anthonyyazdaniml/gliner-biomed-curated-corpus huggingface dataset:
A randomized placebo-controlled clinical trial (Trial 3, NCT04029116) was conducted to evaluate the safety and efficacy of BREXAFEMME 300 mg (two 150 mg tablets) administered approximately 12 hours apart (e.g., in the morning and in the evening) for one day, for a total daily dosage of 600 mg (four 150 mg tablets) administered once monthly for six months. Trial 3 was conducted in the United States (33%), Bulgaria (28%), Poland (12%), and Russia (28%). Non-pregnant post-menarchal females presenting with a symptomatic VVC episode and a history of recurrent VVC (at least 3 episodes of VVC in the previous 12 months) were eligible. The symptomatic episode at Screening was treated with 3 doses of fluconazole 150 mg 3 days apart. 

To be randomized, patients had to have a culture-confirmed VVC  episode at Screening and had to achieve significant resolution of their vulvovaginal signs and symptoms (defined as a total composite score ≤ 2 on the VSS Scale) after fluconazole treatment. Patients were randomized at a 1:1 ratio to receive double-blind BREXAFEMME or placebo administered as a single-day treatment repeated every 4 weeks for a total of 6 single-day treatments. Study visits included the test of cure (TOC) at Week 24 (4 weeks after the last dose) and a follow-up visit at Week 36. The intent to treat (ITT) population was all randomized patients. 

The ITT population consisted of 130 patients treated with BREXAFEMME and 130 patients treated with placebo. The average age was 34 years (range 18-65 years) with 95% less than 50 years. Ninety percent (90%) of patients were White, 8% were Black or African American, and 2% were Asian and other race. Eight percent (8%) of patients were of Hispanic or Latino ethnicity. The average BMI of the patient population was 25 and 16.5% were obese (BMI >30).

Efficacy was assessed as the percentage of patients with Clinical Success, defined as subjects with No Culture Proven, Presumed or Suspected Recurrence of VVC requiring antifungal therapy up to TOC at Week 24. Clinical success was also assessed at the Week 36 Follow-up visit.

Statistically significantly greater percentages of patients experienced Clinical Success at TOC compared to placebo. The clinical success rate at TOC was lower for patients in the United States when compared to patients outside the United States (ex-US) for both BREXAFEMME and placebo groups. In both regions, the BREXAFEMME group had a higher clinical success rate compared to placebo (US: 33% vs 23% and ex-US: 81% vs 68% in BREXAFEMME vs placebo arms, respectively) and the difference between the treatment groups was consistent [US: 10.1% (-9.0, 29.1) and ex-US: 12.9% (0.04, 25.7)]. Clinical Success at Week 36 was also greater for BREXAFEMME compared to placebo. The results for clinical success and reasons for clinical failure are presented in Table 5.

Abbreviations: CI = confidence interval; TOC = test of cure.

1Imputed recurrences are subjects whose clinical outcome cannot be determined due to early termination or missing critical efficacy assessment at TOC.
Cancer has long been viewed as a genetic disease of cumulative mutations. This notion is fuelled by studies showing that ageing tissues are often riddled with clones of complex oncogenic backgrounds coexisting in seeming harmony with their normal tissue counterparts. Equally puzzling, however, is how cancer cells harbouring high mutational burden contribute to normal, tumour-free mice when allowed to develop within the confines of healthy embryos. Conversely, recent evidence suggests that adult tissue cells expressing only one or a few oncogenes can, in some contexts, generate tumours exhibiting many of the features of a malignant, invasive cancer. These disparate observations are difficult to reconcile without invoking environmental cues triggering epigenetic changes that can either dampen or drive malignant transformation. In this Review, we focus on how certain oncogenes can launch a two-way dialogue of miscommunication between a stem cell and its environment that can rewire downstream events non-genetically and skew the morphogenetic course of the tissue. We review the cells and molecules of and the physical forces acting in the resulting tumour microenvironments that can profoundly affect the behaviours of transformed cells. Finally, we discuss possible explanations for the remarkable diversity in the relative importance of mutational burden versus tumour microenvironment and its clinical relevance.
The aim is to determine the safety, tolerability and PK of AMG 479 with sorafenib. AMG 479 will be given bi-weekly; sorafenib will be given daily.
Study K862-08-2002 is a multicenter, randomized, double-blind, placebo-controlled study assessing the analgesic efficacy and safety of T-62 in subjects with postherpetic neuralgia (PHN) and its associated pain. Up to 20 centers in the United States will participate in the trial. Two doses of T-62 and placebo will be evaluated in parallel design. Approximately 130 subjects will be enrolled to complete approximately 100 subjects. Each subject will complete a 7-day Screening Period , a 28-day Treatment Period, and a 14-day Post-Treatment Period. Each subject will complete 8 clinic visits over the course of the study during which procedures and assessments of safety, efficacy, and protocol compliance will be performed.
FIELD: medicine, gastroenterology. SUBSTANCE: method involves oral administration to patient a bactisporin solution by 3 doses, 3 times per a day before eating for the first 3 days, then by 2 doses, 2 times for 7 days. Method ensures to effect on microorganisms Helicobacter pylori and stimulate the regeneration of stomach and duodenum mucosa and prevent the development of dysbacteriosis. Invention can be used for healing chronic gastritis and duodenum ulcer disease. EFFECT: enhanced effectiveness of healing. 1 tbl, 2 ex
This is a randomized controlled single-blinded intervention study in 111 overweight and obese subjects with risk factors of developing type 2 diabetes, with the aim to investigate effects of isoenergetic high cereal fiber versus high protein diets over 6 and 18 weeks. We also investigate effects of a combined high-cereal-fiber/high-protein (mix) diet, and effects in a control group. All diets are based on foods from plants and whey products commonly assumed to be healthy. This trial is designed as a proof of principle study focusing on participants that are likely to adhere to the respective isoenergetic diets, in order to show whether high protein versus high cereal fiber diets indeed affect insulin sensitivity, as indicated by epidemiological observations. Study participants will receive intensive and regular nutritional advice in order to achieve the respective dietary targets. Dietary adherence of the participants will be supported by providing tailored dietary supplements in all four groups, twice daily over 18 weeks. Supplements are provided for twice daily consumption for all participants in all four dietary intervention groups, throughout the 18-wk intervention (each of the participants will be instructed to consume a total 252 portions of tailored supplements during the intervention, which will handed to the participants in sealed single portions at weeks 0, 3, 6 and 12, totalling 63 portions at each occasion). The packaging of the sealed portions for the 4 intervention arms do not indicate the type of dietary intervention for the participant, but are coded for identification by the supplier. Energy contents of the supplements are considered when calculating individual energy intake. Supplements have been specifically designed for this intervention study, in order to facilitate achieving dietary targets. A 6 week strictly controlled isoenergetic study period (regular group and individual sessions, daily food diaries/FFQs over the first 6 weeks with adaptation of food intake, if necessary, as indicated by direct analysis of FFQs and food protocols, and by weighing the participants; 3-day food protocols at weeks 0, 6, 12, and 18; various biomarkers of dietary adherence) will be followed by a further 12 week ad libitum period, with ongoing intake of the respective diet including the supplements, but no further dietary advice. The primary outcome measure is the detection of diet-induced changes in insulin sensitivity during weight maintaining isoenergetic conditions. Secondary outcomes are changes in factors that may explain potential diet-induced alterations of insulin sensitivity. During the 12-weeks ad libitum period we will further investigate potential effects of the respective diet on changes in body weight, body composition and biomarkers related to energy intake. Participants will be re-invited for anthropometric measurements and measurement of biomarkers in blood (18 weeks after completion of the study), as well as for taking a second muscle tissue biopsy (subset of participants that agreed to this procedure).
Both HCV and HIV are associated with an increased risk of osteoporosis and osteoporotic fractures among HIV-infected patients and the general population. While HIV significantly increases cardiovascular risk, the contribution of HCV to cardiovascular disease (CVD) is less certain. Increased inflammation could potentially underlie the effect of HCV on CVD, bone health, and other extra-hepatic complications. HCV appears to remain an independent predictor of osteoporotic fractures even after controlling for severity of liver disease. The impact of HCV therapy on inflammation, CVD and bone health is unclear. Our previous studies suggest a beneficial impact of interferon therapy on bone turnover and some CVD markers, while others studies have found on-treatment increases in bone mineral density with interferon-based therapy. Whether these are related to the interferon itself or the virologic response, and whether changes in biomarkers lead to improved fracture risk or CVD morbidity is uncertain. Investigator propose to conduct a prospective analysis of markers of inflammation, immune activation, and bone turnover as well as bone mineral density (BMD) among both HIV/HCV co-infected and HCV mono-infected patients undergoing treatment with the novel direct-acting antiviral elbasvir/grazoprevir (EBR/GZR). Should EBR/GZR therapy significantly improve CV risk and bone health, it would be an additional benefit and indication for its use in HCV therapy.
OBJECTIVE: Treating high-level athletes involves a balance between early and safe return to play. Various types of protective immobilization have been recommended after operatively treated Bennett's fracture. The purpose of this study was to investigate if hand-based immobilization offers protection equivalent to forearm-based immobilization.
MATERIALS AND METHODS: A cadaveric model of Bennett's fracture was created in 8 fresh-frozen, cadaveric forearms. Osteosynthesis was performed using a single headless compression screw. Three matched pairs were casted in either hand-based or forearm length, thumb spica casts, while 2 specimens remained un-casted as controls. Specimens were mounted on a custom testing apparatus. Weights were added in 6.8-kg increments until fixation failed and the fracture displaced. Fluoroscopy was performed after each trial. We used the Kruskal-Wallis non-parametric test to compare the groups. We considered P<.05 statistically significant.
RESULTS: Failure of fixation occurred at 6.8 kg in the control specimens. Fixation failed in hand-based and forearm length casts at a mean of 18.1±5.1 kg. We did not find a statistically significant difference between median values of load at failure in kilograms across control specimens and 2 immobilization categories (P=.114). All specimens in the hand-based group sustained additional wrist injuries, while no additional injuries were noted in the forearm length group.
CONCLUSION: Our study results showed that hand-based immobilization provides equivalent protection against fixation failure for operatively treated Bennett's fractures but may predispose athletes to increased risk of wrist injury compared with traditional, forearm-based casting. [Orthopedics. 2024;47(3):157-160.].
The cellular and molecular mechanisms governing sexual reproduction are conserved across eukaryotes. Nevertheless, hybridization can disrupt these mechanisms, leading to asexual reproduction, often accompanied by polyploidy. In this study, we investigate how ploidy level and ratio of parental genomes in hybrids affect their reproductive mode. We analyze the gametogenesis of sexual species and their diploid and triploid hybrids from the freshwater fish family Cobitidae, using newly developed cytogenetic markers. We find that diploid hybrid females possess oogonia and oocytes with original (diploid) and duplicated (tetraploid) ploidy. Diploid oocytes cannot progress beyond pachytene due to aberrant pairing. However, tetraploid oocytes, which emerge after premeiotic genome endoreplication, exhibit normal pairing and result in diploid gametes. Triploid hybrid females possess diploid, triploid, and haploid oogonia and oocytes. Triploid and haploid oocytes cannot progress beyond pachytene checkpoint due to aberrant chromosome pairing, while diploid oocytes have normal pairing in meiosis, resulting in haploid gametes. Diploid oocytes emerge after premeiotic elimination of a single-copied genome. Triploid hybrid males are sterile due to aberrant pairing and the failure of chromosomal segregation during meiotic divisions. Thus, changes in ploidy and genome dosage may lead to cyclical alteration of gametogenic pathways in hybrids.
Paget's disease of bone is a chronic, focal skeletal disorder characterized by greatly increased and disorderly bone remodeling. Excessive osteoclastic bone resorption is followed by osteoblastic new bone formation, leading to the replacement of the normal bone architecture by disorganized, enlarged, and weakened bone structure.

Clinical manifestations of Paget's disease range from no symptoms to severe morbidity due to bone pain, bone deformity, pathological fractures, and neurological and other complications. Serum alkaline phosphatase, the most frequently used biochemical index of disease activity, provides an objective measure of disease severity and response to therapy.

Alendronate sodium decreases the rate of bone resorption directly, which leads to an indirect decrease in bone formation. In clinical trials, alendronate sodium 40 mg once daily for six months produced significant decreases in serum alkaline phosphatase as well as in urinary markers of bone collagen degradation. As a result of the inhibition of bone resorption, alendronate sodium induced generally mild, transient, and asymptomatic decreases in serum calcium and phosphate.
Participants will perform an exercise program 3 days a week with a physiotherapist. The group will be held maximum 10 people.
Climate change is expected to undermine population health and well-being in low- and middle-income countries, but relatively few analyses have directly examined these effects using individual-level data at global scales, particularly for reproductive-age women. To address this lacuna, we harmonize nationally representative data from the Demographic and Health Surveys on reproductive health, body mass index (BMI), and temporary migration from 2.5 million adult women (ages 15 to 49) in approximately 109,000 sites across 59 low- and middle-income countries, which we link to high-resolution climate data. We use this linked dataset to estimate fixed-effect logistic regression models of demographic and health outcomes as a function of climate exposures, woman-level and site-level characteristics, seasonality, and regional time trends, allowing us to plausibly isolate climate effects from other influences on health and migration. Specifically, we measure the effects of recent exposures to temperature and precipitation anomalies on the likelihood of having a live birth in the past year, desire for another child, use of modern contraception, underweight (BMI < 18.5), and temporary migration, and subsequently allow for nonlinearity as well as heterogeneity across education, rural/urban residence, and baseline climate. This analysis reveals that exposures to high temperatures increase live births, reduce desire for another child, increase underweight, and increase temporary migration, particularly in rural areas. The findings represent clear evidence that anthropogenic temperature increases contribute to temporary migration and are a significant threat to women's health and reproductive autonomy in low- and middle-income countries.
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based cognitive-behavioral intervention designed to cultivate constructive approach-oriented emotional engagement. The 13-week Emotional Resilience Training (ERST) is an adaptation of the UP designed for use as a proactive training course. The ERST frames emotional experiences as natural responses to threat, rather than pathological occurrences to avoid; as such, the ERST is well-suited for mitigating health challenges and the skills may also help PSP to support persons in distress, including other PSP and the community members they all serve. The ERST training materials include an instructor guide, didactic PowerPoints, and a trainee workbook. The ERST was designed for seamless integration with the Cadet Training Program, effective June 2022, which is what creates the augmented training arm (i.e., the ATC).
The precise mechanism of the analgesic action is unknown. However, specific CNS (central nervous system) opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug. In addition, opioid receptors have also been identified within the PNS (peripheral nervous system). The role that these receptors play in these drugs’ analgesic effects is unknown.

Opioids produce respiratory depression likely by direct action on brain stem respiratory centers. The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation.

Opioids depress the cough reflex by direct effect on the cough center in the medulla oblongata. Antitussive effects may occur with doses lower than those usually required for analgesia. Opioids cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations (see OVERDOSAGE: Signs and Symptoms).
Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent liver disorder in China but still has no exact therapy for this disease instead of improving our diet and enhancing physical activity. Silymarin is a mixture of flavonoids extracted from seeds of Silybum marianum or milk thistle, and its major active compound is silibinin. Because of its antioxidant, anti-inflammatory and antifibrotic power, silymarin has important biological effects in NAFLD. Furthermore, some traditional liver protective Chinese medicines are also helpful in controlling the progression of NAFLD, such as pueraria, schisandra and salvia miltiorrhiza. At present, there are few reports on the combination of silymarin and these traditional Chinese medicines in the treatment of NAFLD. This study aims to test the effect of compound silymarin on laboratory markers and clinical evolution of patients with NAFLD.
The sense of body ownership (i.e. the feeling that our body or its parts belong to us) plays a key role in bodily self-consciousness and is believed to stem from multisensory integration. Experimental paradigms such as the rubber hand illusion have been developed to allow the controlled manipulation of body ownership in laboratory settings, providing effective tools for investigating malleability in the sense of body ownership and the boundaries that distinguish self from other. Neuroimaging studies of body ownership converge on the involvement of several cortical regions, including the premotor cortex and posterior parietal cortex. However, relatively less attention has been paid to subcortical structures that may also contribute to body ownership perception, such as the cerebellum and putamen. Here, on the basis of neuroimaging and neuropsychological observations, we provide an overview of relevant subcortical regions and consider their potential role in generating and maintaining a sense of ownership over the body. We also suggest novel avenues for future research targeting the role of subcortical regions in making sense of the body as our own.
A total of 10 scheduled visits are planned. The visits include a screening visit, 2 operative visits, and 7 postoperative visits. Both eyes will be implanted. The second eye implant will occur within 7-21 days of the first eye implant. The primary endpoint data will be collected at the Month 3 visit. Individual subject participation is expected to last 6-7 months. This study will be conducted in Australia and New Zealand.
323,321. Hashimoto, T. Nov. 17, 1928. Addition to 322,607. Medicaments for external application.-A modification of the invention described in the parent Specification wherein a mixture of rubber, tragacanth gum and volatile solvent is boiled under pressure comprises treating the solution so produced to distillation under reduced pressure to expel the volatile solvent. As an example, well ground rubber is dissolved in ether or benzene while heating, 50-100 parts of solvent being used to 10 of rubber. A solution of 0.5 per cent gum tragacanth is added to reduce the rubber to 8-15 per cent concentration. Distilled water is then added to reduce the rubber concentration to 2-5 per cent. The emulsion is boiled under 10 atmospheres pressure for about 30 minutes and is then kept still and cool. It is then distilled under reduced pressure to expel the volatile solvent. Suitable sterilizing, heating or cleansing substances such as boric acid benzoic acid, glycerine alcohol or caustic potash or perfume may be added.
Mediterranean Low-TMAO (MeLT) diet. Used in cohorts 1, 2 and 3.
BACKGROUND: Reversal of ileostomy is associated with morbidity including wound infection and prolonged wound healing. Negative pressure wound therapy (NPWT) has been shown to reduce time to wound healing by secondary intention. The aim of this study was to determine whether NPWT improved wound healing rates, compared with simple wound dressings, in patients undergoing reversal of ileostomy where the skin wound is closed with a purse-string suture.
METHODS: This was a dual-centre, open-label, randomized controlled trial with two parallel intervention arms. Patients undergoing elective loop ileostomy reversal were randomized 1:1 to receive NPWT or simple wound dressings. The primary endpoint of the study was assessment of complete wound healing at day 42 post reversal of ileostomy and the secondary endpoints were patient-reported wound cosmesis using a visual analogue scale and rates of surgical site infection (SSI).
RESULTS: The study was conducted from June 2018 to December 2021. The trial was approved by the local ethics committee. We enrolled 40 patients, 20 in each arm. One patient in each arm was lost to follow up. Nine patients (9/19, 47.36%) in the simple dressing group had wound healing vs. 13 patients (13/19, 68.42%) in the NPWT group (P = 0.188). There was no significant difference in patient- reported wound cosmesis or SSI.
CONCLUSION: There was no difference in wound healing rates when comparing NPWT to simple wound dressings at early and late time points post reversal of ileostomy, where the skin wound was closed with a purse-string suture.