Latest news with #Valhalla
Medscape
3 days ago
- Health
- Medscape
Weekly Pill Succeeds in Schizophrenia, With Broader Promise
A novel once-weekly capsule loaded with the antipsychotic risperidone, LYN-005, provided similar bioavailability and symptom control as daily doses of the drug in a phase 3 trial of patients with schizophrenia or schizoaffective disorder. The study was stopped early for success after an interim analysis showed all pharmacokinetic values met primary endpoint criteria. Weekly LYN-005 could bridge the gap between daily oral medications and long-acting injectable antipsychotics, which are not universally offered or accepted by patients, the researchers noted. 'One of the biggest obstacles in the care of people with chronic illness in general is that medications are not taken consistently. This leads to worsening symptoms, and in the case of schizophrenia, potential relapse, and hospitalization,' lead author Leslie Citrome, MD, MPH, New York Medical College School of Medicine, Valhalla, New York, said in a news release. 'Having the option to take medication by mouth once a week represents an important option that can assist with adherence for the many patients who would prefer oral medications vs injectable formulations,' he added. The study was published online on June 10 in The Lancet Psychiatry . More Than a Decade in the Making The investigational capsule is about the size of a multivitamin and once ingested, the pill unfolds into a star shape designed to prevent it from being passed from the stomach while the drug is released. Over time, enteric and time-dependent layers on the prongs of the star become more pliable and/or break off, easing passage out of the stomach and through the intestinal tract. Initial details of the drug-delivery platform were reported in 2016 by researchers at the Massachusetts Institute of Technology, Cambridge, Massachusetts, and Brigham and Women's Hospital, Boston, with further development of the star capsule by the current study sponsor, Lyndra Therapeutics. The STARLYNG-1 trial enrolled 83 patients, aged 18-64 years, across five US sites who had schizophrenia or schizoaffective disorder for at least 2 years and were stabilized on any oral antipsychotic drug for 6 weeks or longer. Participants were also required to have no hospital admission for worsening schizophrenia within the past 6 months, a Clinical Global Impressions Scale-Severity score ≤ 4, and a Positive and Negative Syndrome Scale (PANSS) score ≤ 80. After a 7-day run-in period with immediate-release daily risperidone (2 mg or 6 mg), participants received five weekly doses of LYN-005 (15 mg or 45 mg, respectively), with a supplemental half-dose of daily immediate-release risperidone during week 1 of LYN-005 dosing. Participants were inpatients from day -5 to day 8 and from day 14 to the end of treatment and participated as outpatients on days 9-13 to ensure consistent blood sampling and treatment compliance. They were followed for safety for 4 weeks after treatment. Medications for agitation, anxiety, and insomnia were permitted during the study and nine participants received rescue risperidone. In all, 47 participants completed the study and 44 were included in the pharmacokinetic analysis. Sustained Release, No Unexpected Safety Signal The primary endpoints were the minimum concentration (C min ) of the active moiety of LYN-005 at weeks 1 and 5, and the maximum concentration (C max ) and average concentration (C avg ) of the active moiety of LYN-005 at week 5 compared with immediate-release risperidone on day -1. Geometric mean ratios (GMRs) of LYN-005 vs immediate-release risperidone were 1.02 for C min at week 1 (90% CI, 0.93-1.12), and 1.04 for C min (90% CI, 0.87-1.23), 0.84 for C max (90% CI, 0.77-0.92), and 1.03 for C avg (90% CI, 0.93-1.13) at week 5. LYN-005 concentrations were maintained above the target threshold (C min : GMR, 1.04) and remained below peak concentrations of immediate-release risperidone, suggesting stable drug delivery over time, the authors noted. Changes in mean PANSS total scores were minimal regardless of LYN-005 dose and scores were maintained in the mid-50s throughout treatment, indicating relatively mild symptom severity and stable disease control with LYN-005, they added. Among 67 participants who received at least one dose of LYN-005, 56 (84%) had at least one adverse event and nine (13%) participants had an event that led to study withdrawal. Gastrointestinal-related events were the most common (66%) and most were mild (75%) and lasted < 3 days. GI events that persisted for more than 3 days included gastroesophageal reflux disease, dyspepsia, and constipation. Other common adverse events were headache (12%), nausea (10%), and back pain (8%). One serious treatment-emergent adverse event (esophagitis) was reported during follow-up and resulted in full recovery. There were no fatal adverse events. Mean Somatic Symptom Scale-8 scores were none to minimal (0-3 score) across the 5 weeks and were weakly correlated with the number of gastrointestinal-related adverse events reported over the same period. Two thirds (68%) of patients and 53% of physicians reported a score ≥ 3 on a 5-point Likert scale, with 1 being very dissatisfied and 5 very satisfied with LYN-005. 'It works and the whole point of treating schizophrenia is adherence, getting them to take the medicine,' Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford University School of Medicine, Stanford, California, told Medscape Medical News . 'Some patients will take it oral; some take it injectable; and there are some patients who are very resistant. This sounds like another way a doctor can try.' The investigators acknowledge that the relatively stable trial population does not represent the heterogeneity seen in clinical practice and that strict inclusion criteria might limit generalizability to the broader schizophrenia population. Other limitations include few female participants (25%) and that the controlled clinical setting with structured support and regular inpatient monitoring might have allowed for greater adherence. The double-blind, placebo-controlled trial STARLYNG-2 trial was to evaluate the long-term safety and tolerability of LYN-005 but the trial was withdrawn in April 2025. Lyndra Therapeutics is investigating the use of the star capsule to deliver other drugs, including weekly levomethadone for treatment of opioid use disorder, monthly contraceptives, and an oral biweekly ivermectin for malaria, according to the company website.
Gizmodo
6 days ago
- Entertainment
- Gizmodo
The MCU Might Be Planning Even More Returning Faces
James Gunn teases the arrival of Superman's 'Justice Gang'. Don't expect a sequel to Transformers One. Plus, what's coming on the next Rick and Morty. To me, my spoilers! The MCU During a recent interview with THR, Karen Gillan only answered 'I can't say, but watch this space' when asked about Nebula's potential return to the MCU. Thor 5 According to insider Alex Perez, there is 'interest' at Marvel to bring Cate Blanchett's Hela back, likely for scenes set in Valhalla in an upcoming Thor project. I know there's interest in bringing the character back, but I don't think it's for the Avengers movies. Maybe in Thor 5? Superman James Gunn shared a behind-the-scenes photo of himself alongside Nathan Fillion's Guy Gardner, Isabela Merced's Hawgirl, Edi Gathegi's Mr. Terrific, and Anthony Carrigan's Metamorpho on the set of Superman. Transformers One, Part II According to a new report from Transformers World 2005, director Josh Cooley confirmed there are 'no plans' for a sequel to Transformers One at Paramount. Went Up the Hill Stranger Things' Dacre Montogermy plays a man named Jack opposite Phantom Thread's Vicky Krieps as a woman named Jill who become alternately possessed by the spirit of Jack's late mother (named Elizabeth…) in the trailer for Went Up the Hill. Crystal Lake Deadline reports Devin Kessler, Gwendolyn Sundstrom, and Cameron Scoggins have joined the cast of the upcoming Friday the 13th TV series, Crystal Lake. Kessler will play a new character named Briana Brooks, while Sundstrom is said to play someone named Grace. Scoggins has been cast as Officer Dorf, a minor character first played by actor Ron Millkie in the original Friday the 13th. Resident Alien Harry and D'arcy travel back in time to 1970 in the trailer for next week's episode of Resident Alien. Revival Syfy has also released a new 'this season on…' trailer for its new series, Revival. Rick and Morty Finally, Rick and Morty loot an interstellar ark while its crew are in suspended animation in the trailer for next week's episode.
Medscape
12-06-2025
- Health
- Medscape
The Most Vicious Cycle of All: Cardiac PTSD
Just surviving a major cardiac event is an achievement, but of course getting through whatever initial resuscitation and procedures necessary are merely the first steps. As a patient embarks on their rehabilitation journey, one incredibly dangerous setback cardiologists must be on the lookout for is cardiac posttraumatic stress disorder (PTSD). This remarkably common complication — according to a 2004 study published in Critical Care Medicine , as many as 27% of those who survive cardiac events may develop PTSD — can not only cause noncompliance with medication and other ongoing treatment modalities but also put the patient at an increased risk for a second cardiac event. 'In the aftermath of cardiac arrest or a heart attack, one of the most overlooked aspects of recovery is the emotional toll it takes, said Srihari S. Naidu, MD, a professor of medicine at New York Medical College and director of the Cardiac Cath Labs at the Westchester Medical Center Health Network, both in Valhalla, New York. 'The experience can be deeply traumatic, not just for the patient, but for their loved ones as well. Despite this, mental health remains one of the least systematically addressed components of cardiac care.' One problem, Naidu said, is that we 'still, we lack standardized approaches to routinely screen, diagnose, and treat PTSD in this vulnerable population.' Indeed, the American Heart Association identified this as a problem in its 2020 scientific statement, Sudden Cardiac Arrest Survivorship. In this publication, the association said the coordination of multidisciplinary care, to include emotional care, must start as early as within the ICU, but that it needs to continue throughout the recovery period. Srihari S. Naidu, MD 'Without a coordinated plan during hospitalization to assess both short- and long-term recovery needs, we risk missing the broader picture,' said Naidu, who is also the president of the Society for Cardiovascular Angiography and Interventions. 'In my experience, the outpatient clinic visit is often the first, and sometimes the only, opportunity to uncover these issues, which may manifest as anxiety or persistent thoughts about the event, or a variety of unrelated symptoms.' James Jackson, MD, director of Behavioral Health and professor of medicine and psychiatry at Vanderbilt University in Nashville, Tennessee, said the symptoms are all united by one thing: The fact that the patient has the source of their trauma with them at all times. 'If you're carrying your heart around with you and the heart is the source of the trauma, you're constantly reminded, right? And if your cardiac event developed out of the blue, the concern is it could develop out of the blue again, right? So you're carrying this trauma around with you. It's a constant reminder,' he said. 'The trauma is not parked somewhere in the rear view. The trauma is sort of in the present and even in the future.' Symptom-wise, this trauma manifests itself in a variety of ways and can often go overlooked due to the focus on the physical recovery, Naidu said. 'During follow-up, subtle cues begin to emerge; patients who seem emotionally distant, who have trouble sleeping, or who avoid talking about what happened (can be red flags),' he said. 'PTSD doesn't always present dramatically.' Sometimes, Naidu said, it's the patient who suddenly bursts into tears when recalling the event. Other times, it's the one who avoids follow-ups, skips cardiac rehab, or steers clear of anything that reminds them of the hospital. Early symptoms may include hypervigilance, nightmares, intrusive memories, emotional numbness, and avoidance. The Cycle Folds Onto Itself When you break it down and look at triggering factors, it's not hard to understand how PTSD becomes a self-fulfilling prophecy. 'Often with patients in a cardiac context, they get quite anxious. Their heart starts beating fast, and then they really worry. And so their response to that is, I'm going to withdraw. I'm going to disengage,' Jackson said. While physical activity or exercise often helps reduce stress, patients are often short of breath and are reminded how it felt when they were having the attack. James Jackson, MD 'And so if they start to exercise, it's all well and good,' Jackson said. 'But as soon as they get slightly short of breath, even if they're fine physiologically, as soon as they get short of breath, they're going to shut that down. And this is just one example, but it becomes a very isolating sort of process.' Patients left in this sustained crisis state experience a significantly diminished overall quality of life, and a study led by Antonia Seligowski and published in the March 2024 issue of Brain, Behavior, and Immunity found that PTSD after cardiac arrest significantly increases the risks for both major adverse cardiovascular events and all-cause mortality within just 1 year of discharge. This is supported by the findings of Donald Edmondson, MD, associate professor of behavioral medicine in medicine and psychiatry at Columbia University Irving Medical Center, New York City, both in his 2013 study published in the American Heart Journal and in research he has done since. 'Over the years now, we've studied cardiac patients, both acute coronary syndrome, so myocardial infarction, as well as cardiac arrest and stroke,' Edmondson said. 'What we see is that between 15 and 30% of patients will screen positive for PTSD due to that cardiac event 1 month later. Those who screen positive for PTSD are at least at doubled risk, if not greater, for having another cardiac event or dying within the year after that first cardiac event.' These outcomes highlight how critical it is to address PTSD early and effectively, Naidu said. 'As cardiologists, we often focus on optimizing medications, procedures, and physical rehabilitation, but without integrating behavioral support, we're missing a major part of the healing process,' he said. PTSD and cardiovascular disease have a well-documented relationship: PTSD can worsen cardiovascular risk, and in turn, living with heart disease can amplify psychological stress. Jackson said that there are behavioral health approaches at work in other areas that may be useful for cardiac events that are not sudden onset. 'There's a general sort of a movement afoot called prehab,' Jackson said. 'The general idea about prehab would be, 'Hey, you're going to have this surgery. We think that it's going to knock your brain down. So we're going to try to do some brain training with you before the surgery, and we think that in doing that, we're going to build your reserve up.' Is There a Type? Although a 2022 study led by Sophia Armand and published in the Journal of Cardiovascular Nursing showed that younger age, female sex, and high levels of acute stress at the time of the event to be significant risk factors for developing PTSD after cardiac arrest. There's no one overarching 'profile' in terms of who's likely to develop PTSD after any cardiac event. Naidu has his hunches, though. Donald Edmondson, MD 'I would say that I suspect cardiac arrest is more frequently associated with PTSD than other types of cardiac events. Compared to conditions like myocardial infarction or unstable angina, the psychological impact of cardiac arrest, particularly when complicated by anoxic brain injury, tends to be more profound,' Naidu said, cautioning that individual risk factors should be weighed in every case. 'Anoxic injury significantly increases the risk of depression, anxiety, and PTSD, often for an uncertain duration.' At Columbia, Edmondson said there are two indicators that together predict a high risk for a cardiac patient developing PTSD. 'They tend to pay close attention to their cardiac sensations and catastrophize them,' Edmondson said of the patients who go on to develop PTSD. 'Initially, in the ER [emergency room], they're extremely distressed. Then, post event, they'll say over the past 4 weeks, when I feel my heart beating fast, I worry that I'm having another heart attack. Or if I feel short of breath, I worry that I'm going to die.' 'Having those two predictors together, so initial high distress in the emergency department and this sort of high, what we call interoceptive bias, those two things together place people at high risk for developing PTSD at that 1-month period (after their cardiac event).' Regardless, more research must be done on this extremely risky and highly debilitating mental health issue that's so deeply entwined with its cardiac trigger. 'More focused studies are needed to better understand the timing, risk factors, and mechanisms behind these symptoms, and to develop standardized strategies for early screening, intervention, and long-term psychological support,' said Naidu. 'An urgent need exists to screen for and treat PTSD, not just for mental health but to help prevent repeat hospitalizations and improve long-term cardiovascular outcomes.'
Boston Globe
10-06-2025
- Sport
- Boston Globe
Rory McIlroy still looking for motivation after historic Masters win
'I think it's trying to have a little bit of amnesia and forget about what happened,' McIlroy said Tuesday when asked about the difficulties he has faced — on the golf course, at least — since donning the green jacket. 'Then, just trying to find the motivation to go back out there and work as hard as I've been working.' Advertisement That edge has been tough to rediscover, buried somewhere beneath the satisfaction of finally conquering Augusta National to become only the sixth player to win all four majors in his career. He has celebrated by taking more trips, playing more tennis, hanging out at home and 'basically saying 'no' to every request that comes in.' His forays back to his day job — rough. McIlroy arrived at the PGA Championship a month after the Masters only to learn that the driver he'd been using for more than a year had been deemed nonconforming in a routine test. He hit only 46.4 percent of the fairways that week, tying him for 68th out of 74 players in that statistic who played four rounds. Those struggles with the new driver made him a nonfactor and he finished tied for 47th. Advertisement 'It wasn't a big deal for Scottie, so it shouldn't have been a big deal for me,' McIlroy said, noting Scottie Scheffler received the same news about his own driver that week but went on to win the tournament. That the normally closely held news of McIlroy's illegal driver leaked to the media and Scheffler's did not annoyed McIlroy, and he said last week that was why he didn't speak to the media after all four rounds at Quail Hollow. That issue appears to be behind him. The driver? He says he's figured it out — 'I mean, come out and watch me hit balls, and you'll see,' he said — which means the answer must have come during his weekend off after rounds of 71-78 at the Canadian Open last week left him far short of making the cut. The 78 matched the second-worst score he's ever shot in a PGA Tour event. The next test starts Thursday at a brutal, brutish Oakmont course that McIlroy said might be playing easier than the last time he was here. No, he wasn't talking about 2016, when he missed the first of three straight U.S. Open cuts, but rather, last Monday, when he needed to go birdie-birdie down the finish to shoot 81 in a practice round. 'It didn't feel like I played that bad,' McIlroy said. 'It's much more benign right now than it was that Monday. They had the pins in dicey locations, and greens were running at 15½ [compared to an estimated 14½ for the tournament]. It was nearly impossible. But yeah, this morning, it was a little softer.' Advertisement Speaking of soft courses, McIlroy said he bristled at the reputation that began developing after his first major title, in 2011, when he demolished a rain-dampened Congressional with a U.S. Open-record score of 268 that still stands. His other majors — at Valhalla, Kiawah, and Royal Liverpool — were also on soft courses. All that, plus his inability to capture the Masters, led critics to label him a player who couldn't conquer firm and fast. 'I didn't like that reputation because I felt like I was better than that reputation, so that's ego driven in some way,' McIlroy said. He tailored his game to handle the toughest conditions the majors can offer. He has runner-up finishes at the last two U.S. Opens as proof that project worked. But golf always presents new challenges. These days, McIlroy's is whether he can find that kind of fire — this week, next month, next year or beyond — now that he had made it over his biggest hump at the Masters. He served up one clue of where his head is when asked what his plan for the next five years might be. 'I don't have one. I have no idea,' he said. 'I'm sort of just taking it tournament by tournament at this point.'
Yahoo
06-06-2025
- Yahoo
Brian Brobbey blackmailed: explosive reports emerge about Ajax striker
As per Het Parool and VoetbalPrimeur, Ajax's Brian Brobbey has reportedly been the victim of blackmail. A good friend of his was 'shot as a result and barely managed to survive'. According to Dutch investigative circles, Brobbey fell victim to what is referred to as the 'Holleeder method'. This refers to when one Willem Holleeder and his accomplices deliberately created fake conflicts in which they made wealthy businessmen believe that they had problems with heavy-hitters from the criminal circuit. They then offered to solve these fictional problems in exchange for large sums of money. Advertisement Brobbey's unfortunate situation concerns the notorious Antillean-Amsterdam criminal Jeymon A. (31) according to sources within the police and justice system. He used a 'classic extortion trick' to get the better of Brobbey. Jeymon A., known in the underworld as 'Piccalo', approached the Ajax striker in 2022 at Valhalla, an annual festival at the RAI complex. During that approach, Brobbey was told that 'Moroccans from Utrecht' were looking for him. Jeymon A. claimed to have solved that for him, but made it quickly known that he wanted a fee. Brobbey claimed that he did not know the 'Moroccans from Utrecht' and told the story to a good childhood friend, who at that time was himself the subject of an investigation into drug trafficking. While it's likely Brobbey did not know that at that time, the childhood friend promised to solve the problem himself. Reports of attacks During the night of 15 to 16 January 2023, Brobbey's mother-in-law's mailbox was damaged with heavy fireworks. Two months later, an explosive was set off at Brobbey's car on the night of the 18th of March. This attack resulted in a tumultuous night for the striker, who came on as a substitute in the 77th minute a day later in De Klassieker, when Ajax lost 3-2 and ultimately gave up the title. Advertisement At first, the police assumed intimidation came from Feyenoord hooligans. However, it was later linked to the extortion of Jeymon A. With this, the incidents only got worse. First, his sister-in-law's car was set on fire. Then, two months later, on July 9, Brobbey went to play padel with his brothers and his childhood friend. In the evening, said friend met Jeymon A. on his own initiative, to try and solve the problem. Following a confrontation, the friend was eventually shot and barely made it to a police station. Reports continue, claiming that although the childhood friend didn't want to say anything about the incident, later phone records show that he 'took a bullet for Brobbey'. Subsequently, the pressure on the Ajax man increased. The striker received a text message that he 'has to pay 150,000 euros before the end of the month, otherwise they will do it differently'. It is also claimed that they know where he lives. Advertisement Fortunately, the shooting incident turned out to be Jeymon A.'s last violent incident after he was arrested for various cases. He has now been sentenced to 10 years in prison for attempted manslaughter of Brobbey's childhood friend, possession of a firearm and possession of 1.6 kilos of MDMA. There are no indications that Brobbey paid the money. The striker is said to have given his childhood friend money, but according to him, that was unrelated to the incident. GBeNeFN | Max Bradfield
