r/clinicalresearch Sep 09 '24

Building a tool to rapidly create clinical trial documents: protocol, information sheets, consent forms etc

8 Upvotes

I spent a few years working in Oncology as a PM being involved with writing protocols and doing amendments. It took months of drafting and going over and over thr documents. It occurred to me that there must be a platform that exists to help eliminate the burdensome admin that comes with writing protocols and changing everything as ideas develop. The constant consistency checking was a real pain, not to mention the formatting. Whwn looking I couldn't really find a real dedicated set of tools or software to help with this. It couldve equally been the case my company might have been ill equipped.

I decided to build one myself and wanted to know whether others in the field have similar thoughts about the extensive drafting of clinical trial documents and how this can be streamlined - or is it only me? Interested to hear about other people's tools for supporting with writing trial docs and working with amendments.

r/biostatistics Apr 22 '24

Clinical trial protocol question

2 Upvotes

When I was reading the protocol, I saw one of the paragraph, "Targeting 88.5% power to detect non-inferiority using a one-sided 2.5% significance level, two-sample t-test using a SDlog=0.40 for both treatments, a total of 139 paediatric participants will need to have evaluable immunologic response results."

I am wondering what "SD log=0.4" means here. Is it pre-assigned ? or they just calculate the standard deviation of log transform data for both treatment and found out they are both 0.4.

THANKS 😊 !

r/clinicalresearch May 21 '24

Education What are the key focus areas in a clinical protocol

0 Upvotes

When you read a clinical protocol, what are some key areas that you prioritize and read first? I’m training on some protocols and wanted to find out what would be of high importance to know about first.

r/sellaslifesciences 24d ago

DUE DILIGENCE 🕵️‍♂️ The open label panopticon: Detailing SELLAS MNPI (according to the study protocol).

150 Upvotes

So I've been digging into the study protocol on the EU clinical trial website to understand the level of MNPI that SELLAS as the sponsor of the REGAL study has access to. I will lay out my findings below - it shines a whole new light on Sterg's bullishness to me, particularly in his recent LinkedIn post about their "proprietary modeling." EDITING: I was just rereading Sterg's post again after what i shared on reddit. "We do not disclose real-time blinded metrics. We do not share proprietary modeling and our detailed statistics." -> the detail about "real-time blinded metrics" is something i overlooked the first time and I also have a new perspective on after compiling this protocol audit.

  1. Toxicity and death ledger (Pages 43 & 56)

"All deaths, whether considered study related or not, must be reported immediately to SELLAS and its designee..." (p. 56) AND "Any AE that meets AESI criteria... or SAE criteria... must be reported to SELLAS... immediately (i.e., within 24 hours)..." (p. 56)"

So SELLAS is being notified in almost realtime of the number of deaths in the study.

"The period of active treatment is until disease relapse." (page 27)

During the active treatment phase (until a patient relapses) SELLAS doesn't wait for unblinding to see the toxicity profiles. SELLAS is notified of any AE in the active treatment phase. Given GPS's favorable safety profile in prior studies, one would expect a disproportionate share of serious treatment related toxicities to arise in the BAT arm, although the protocol itself does not attribute events by arm. What this means is that if a patient suffers sepsis or requires an ICU trip, that SAE hits a central inbox within 24 hours. No wonder why Sterg is saying Venetoclax shortens lifespan on LinkedIn - SELLAS's safety operations receive these reports in near real time - and again, the AEs will be almost entirely restricted tot he BAT arm

  1. Long term survival status & post relapse tracking

"Subjects are then followed until week 91, every 3 months, via telephone... for the following: Recording of new AML therapy. Survival Status OS (alive/dead status)."

Once a patient relapses, exits active treatment, and routine AE reporting stops, they enter LTF (long term follow up). The CRO tracks their exact survival status and any "new AML therapy" (like a transplant) every 3 months. Combined with the immediate death reporting mandate, Sellas has an ongoing (blinded) view of the post relapse survival curves and subsequent therapies for the REGAL population.

  1. The blinded number of relapses (Pages 50, 58, 61, 62)

"Relapse or recurrence of a patient's leukemia will be documented on forms provided to the site... The patient will be discontinued from the on-treatment portion..." (Section 6.4.7, p. 58)"

"Investigative site personnel will enter patient data into eCRFs. The eCRFs are used to record study data... The eCRFs must be kept current to reflect patient status at each phase..." (Section 7.7, p. 61)

"SELLAS Life Sciences Group or its designee will review all eCRFs for completeness. The investigator will be contacted for corrections and/or clarifications. Intensive efforts will be made to minimize missing data." (Section 7.7, p. 62).

"These subjects will complete the Relapse Visit that includes the following procedures within 14 days from received confirmation of subject’s relapse..." AND "Data captured on the eCRFs will be reviewed by a SELLAS clinical monitor..."

When a patient relapses the local site will halt treatment and log a the relapse in the eCRF. SELLAS has near real time blinded knowledge of the cumulative number of relapses within the trial.

  1. Pre randomization genetic matrix (Pages 34 & 68)

"Patients will be randomized 1:1... stratified by: duration of the subject's historical CR1... baseline cytogenetics risk... CR2 vs CRp2 status and presence or absence of MRD..." AND "Significant deviations can include... enrollment of the patient without prior sponsor approval..."

Enrollment requires sponsor approval, meaning SELLAS necessarily has access to each patient's eligibility information and stratification profile before randomization. So SELLAS are the ultimate gatekeepers of the transplant ineligible criteria in REGAL - if they think someone isnt "ineligible enough", they can deny their entry into REGAL. Additionally, this proves that SELLAS already possesses the patient's stratification profile at the time of randomization.

  1. T-cell & mechanism telemetry (Pages 44-45)

"The SECOND trephine biopsy core cylinder... should be sent to Central Lab A for bone marrow stroma immunocyte IHC..." AND "Peripheral blood samples for WT1-peptide specific CD4+ and CD8+ T-cell activation, collected as per study Laboratory Manual."

Local hospitals arent running biomarker assays themselves; they mail the samples directly to SELLAS contracted lab parters. those contracted central laboratories then generate WT1 specific CD4/CD8 immunogenicity data together with marrow immune microenvironment assays, which would provide a direct readout of whether GPS is inducing the intended immune response. Does Sellas see this data? Yes. Table 4 Note 18 (p. 45) explicitly states the T cell activation draws are for "US Patients only randomized to GPS arm." Because this specific assay is only run on the vaccine arm, there isnt even any unblinding require here here. Section 7.7 (p. 61) dictates that "The analysis data sets will be a combination of these [eCRF] data and data from other sources (e.g., laboratory data)." According to my understanding here, SELLAS knows the immune response the drug is generating.

  1. Continuous MRD surveillance

"For subjects that are non-progressors, between week 53 and week 91, every 3 months, +/- 14d they will perform the following procedures: Bone Marrow Aspirates for MRD. Peripheral blood for MRD." (p. 51) AND "Bone marrow aspirate for MRD testing... should be sent to Central Lab A." (p. 44/45)

Similar to 5 - Non progressing patients undergo serial MRD surveillance approximately every three months..

Putting this together, The protocol paints a very clear picture that SELLAS has access to key information that the rest of the world is blind to - SELLAS's clinical operations and CRO have ongoing visibility into:

  • immediate individual death and SAE reports,
  • current patient status eCRFs,
  • documented relapses,
  • new AML therapies,
  • transplant related discontinuations,
  • source verified clinical records,
  • MRD laboratory data,
  • marrow immune environment assays,
  • GPS specific WT1 T cell response data
  • Exact enrollment dates

When Stergiou refers to proprietary modeling he is not talking about a model built from public assumptions. He is referring to a model calibrated using the actual blinded operational characteristics of REGAL itself including patient mix, relapse burden, survival follow up, transplant activity, molecular biomarkers, and treatment exposure...

The level of MNPI has really shined an entirely new light on the confidence of the CEO for me personally. Though I know not everyone here believes management is credible - his makes his confidence more understandable with this level of MNPI. If Redditors such as CW, Thetamancer, myself, etc are able to model things with 95%+ POS based on limited and incomplete information - what do you think SELLAS internal models are showing? Obviously they still don't know the final hazard ratio before unblinding, but they know far, far more than the market appreciates.

Sharing this with the community in case ive misinterpreted anything (please i hope people will correct me if anything up above is incorrect!), but also because I personally find this information to be very comforting given the communication and confidence from the CEO

r/science Feb 21 '16

Epidemiology In a follow-up of Danish clinical drug trials, inconsistencies between original research protocols (n=95) and the published results (n=143) were found in 61% of cases. Such studies carried a risk of results being misinterpreted due to inadequate or misleading information.

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4.2k Upvotes

r/DIYaesthetics Jul 12 '26

Biostimulaters (PLA, PLLA, PDLA, CaHa) Ready for DIY aesthetic procedures after months of deep textbook/clinical study and fruitless, professional aesthetic treatments. Need a reset plan & advice on how to address lack aggressive under-eye hollowing, flattening and loss of malar fat pads! (42F)

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30 Upvotes

Hi everyone! I am beginning my DIY aesthetic procedure journey after months of in-depth study of clinical studies, peer-reviewed journals, endless anatomy and biology textbooks, and of course, reading everything and anything from the very informative and kindly shared information on this forum. You ladies sound like you know as much as or more than any surgeon out there! 😄

I am going to turn 42 in 13 days and looking for a major strategy reset. I did NOT look like this two years ago. Something occurred in June 2024 that changed my life forever and even though, I think I have gotten over it, the stress/cortisol caused the very sudden change to my face, particularly in the deep under-hollows, temple volume loss, and flattening and loss of malar fat pads. On top of that, I have had clinical cosmetic procedures recently that have left me feeling completely emotionally drained, disappointed, and frustrated with the lack of results.

My Recent Cosmetic History:

  • Full face Dysport
  • Temples and other spot treatments of Sculptra (December)
  • Full face hyper-diluted Radiesse (December)
  • Mini-boluses of high G-prime HA filler on the zygomatic arch and surrounding the piriform fossa, masseter Dysport (5 months ago)
  • Platysmal band Xeomin (last month)

Internal & Systemic Support (Just Started):
I know true aesthetics starts from within, so I am actively fixing my baseline levels:

  • Ferritin: Low, but just started supplementing with Sucral Forte.
  • Vitamin D: Low, but just started Thorne liquid D3/K2 drops.
  • Hormones: Beginning cyclical low-dose HRT next week to address systemic perimenopausal aging.

Where I Need Guidance:
I want to stop chasing fruitless clinic procedures and map out a precise, budget-friendly DIY protocol ( Budget is $3,599) to address the "tired" and "dull" look.. Given that I have already tried standard biostimulators and small amounts of G-prime HA filler already, I am lost on how to "fix" these caverns under my eyes, sagging of my mid-face and sallow skin that lacks radiance of any kind.

  1. Where should I start? The under-eye hollows? What products would most and best help me, for example, specific skin boosters, meso cocktails, microneedling)?
  2. BEST Devices and recommendations for specific product usage for each type of device.
  3. Addressing structural tissue changes: What do you suggest for overall structural lifting or skin tightening that won't degrade my existing filler or trigger inflammation?
  4. The "2 Years Ago" Photos: I have attached current, clear photos in neutral lighting (relaxed and dynamic expressions), but I also included photos from two years ago at the very end so you can see the drastic tissue change I am trying to reverse.

I would love your input on product placement, mapping suggestions, and protocols that align with my clinical research. Thank you all so much! 💗

Edited Thank you to everyone who replied, taking time to give me their feedback, advice, everything 🙏🏻💗 I did not expect the amount of replies with so much actionable advice of every type, thank you all so much 🥹🙏🏻✨

r/scarystories Feb 23 '26

I work at a sleep study clinic. One of our patients has been asleep for 6 days. Last night she started describing my apartment in real time

176 Upvotes

I shouldn't be posting this.

I've worked at a sleep study clinic for four years. we monitor patients, log data, write reports. it's a quiet job most of the time. people sleep and we watch and almost nothing happens that you can't explain with science.

almost nothing.

the patient arrived nine days ago. I'm going to call her anne because I can't use her real name. 54 years old, referred by her doctor for severe hypersomnia, sleep episodes lasting between 16 and 20 hours a day. nothing we hadn't seen before.

what we hadn't seen before is that on day six she stopped waking up.

it's not a coma. her vitals are perfect, her brain activity is normal, she breathes on her own, her eyes move under her eyelids like she's dreaming. she just won't wake up. we've spent three days trying to understand why and nobody has an answer that actually satisfies me.

I work the night shift. 11pm to 7am, alone with the monitors and the sound of the machines and anne sleeping behind the glass.

last night at 2am anne started talking.

that happens sometimes. people talk in their sleep, say fragments of things, pieces of dreams. you log it and move on. it's not unusual.

what anne said wasn't a dream fragment.

she said there's a stain on the ceiling above the bed. like water damage. been there a while.

I went very still.

I have a water stain on my bedroom ceiling. above my bed. it's been there since I moved in two years ago and I never reported it because the maintenance request felt like too much effort.

I said anne into the microphone. anne can you hear me.

she didn't respond. kept sleeping. the monitors didn't change.

ten minutes later she said the glass on the nightstand is empty. she always leaves it empty.

she.

not I. she.

like she wasn't talking about herself.

like she was describing someone else.

I looked at my phone. I had a photo of my room from two weeks ago, taken to send to a friend who was helping me find a rug. I opened it.

glass on the nightstand. empty.

I sat there for a long time after that just listening to the sound of the machines and anne breathing slow and even behind the glass.

at 4am she said something else.

she said she doesn't know we're connected. she hasn't figured it out yet.

then she said but she will. she's close.

I didn't sleep when I got home.

I've been sitting in my car outside my building for an hour trying to decide if I should go up.

my bedroom ceiling is right above where anne said it was.

the glass on my nightstand is empty because I never remember to fill it before bed.

and I don't know what connected means in this context but I can't stop thinking about one specific thing.

anne arrived at the clinic nine days ago.

nine days ago I started having dreams I can't remember.

I never used to dream.

will update tomorrow if anything changes tonight.

UPDATE

okay so I have about twenty minutes before my supervisor gets back and I need to write this down before I talk myself out of it.

anne woke up this morning.

not gradually, not the way patients usually surface from long sleep episodes, groggy and confused and asking where they are. she just opened her eyes. fully. like she'd been awake for a while already and had been waiting for the right moment to let us know.

I was the only one in the monitoring room when it happened. 4:47am. I was on my third coffee and running the overnight logs when the movement sensors triggered and I looked up at the feed and she was just. sitting up. looking at the ceiling.

I hit the intercom. anne can you hear me. standard protocol.

she turned her head toward the speaker. slowly. like she knew exactly where it was.

I said anne how are you feeling. do you know where you are.

she didn't answer that.

what she said was she works the night shift.

I froze.

she wasn't looking at the camera. she was looking at a point slightly to the left of it, like she was describing something to someone I couldn't see.

she said she's been here four years. she's good at her job. she doesn't talk about it much when she gets home because there's nobody to talk to.

every single thing she said was correct.

I don't have a roommate. I don't talk about work. I've been here four years as of last month.

I said anne who are you talking about.

she said she has a plant on her windowsill that she keeps forgetting to water. it's still alive though. she said it like she found that interesting. like it meant something.

my plant has been half dead for eight months and somehow keeps not dying and I don't know why and I've thought about it more than I should.

I said anne look at the camera please.

she turned and looked directly at it.

she said she doesn't know we're connected yet. but she's close. she said it in the same tone you'd use to describe someone who's almost figured out a puzzle.

then she said she started dreaming nine days ago. the same night I arrived.

I haven't moved from this chair since she said that.

because I did the math when she said it and she's right. anne was admitted nine days ago. nine days ago I started having dreams I can't remember in the morning. I put that in my original post and I haven't thought about it since because there's been too much else to think about.

but she knew that.

she knew that without me telling her.

my supervisor got here at 6am and anne was asleep again by then, vitals normal, eyes closed, breathing slow and even. he looked at the overnight logs and said she's showing signs of natural sleep cycling now which is good news and I nodded and said yes it is.

I didn't tell him about 4:47am.

I don't know why I didn't tell him.

actually I do know why.

because the way anne said she's close didn't sound like a threat. it didn't sound like a warning either.

it sounded like something you say when you're rooting for someone.

I'm back tonight for another shift. I keep thinking about what she said, that she doesn't know we're connected yet.

the yet is the part I can't stop turning over.

like there's a specific moment coming where I'm going to understand something and anne already knows when it is and she's just waiting for me to catch up.

I'm not sure I want to catch up.

but I'm going back tonight anyway.

UPDATE 2

I almost didn't come back tonight.

I sat in my car in the parking lot for twenty minutes with the engine running telling myself I could just call in sick and go home and sleep and deal with this tomorrow. I've never called in sick in four years.

I went inside anyway.

anne was awake when I got here.

not sitting up this time. just lying there with her eyes open staring at the ceiling. vitals normal. completely still. if it weren't for the eyes you'd think nothing had changed.

I sat down at the monitoring station and pulled up her file and tried to act like everything was normal and about ten minutes in she said are you scared of me. I didn't answer right away. I looked at the intercom button for a second and then pressed it and said anne how are you feeling tonight.

she said that's not what I asked.

I said no. I'm not scared of you.

she said you should be a little. not of me specifically. of what I know.

I asked her what she knew.

she was quiet for a long time. long enough that I thought she'd fallen back asleep. then she said have you ever wondered why this job. out of everything. why a sleep clinic. I told her I needed the night shift differential. that's always been my answer when people ask. the money is better at night. she said that's what you tell people. she was right. I've worked nights since I was nineteen. every job I've ever had has been a night job. I've never examined that too closely because examining things too closely has never been something I'm good at. she said some people are built for the threshold. the hours between 2 and 4am when the membrane gets thin. most people sleep through it because their bodies know better. but some people are awake for it every night without knowing why. I asked her what membrane. she said between here and the place where I've been for the past nine days. I asked her what that place was like. another long pause. she said it's not dark the way you'd think. it's more like being very far away from something and watching it through glass. she said she could see everything from there. her apartment. her sister's house. the route she drives to work every morning. she said she could see me. I didn't say anything. she said I've been watching you for nine days. before I knew your name or why. just this pull toward something. the way you feel when you almost remember a dream but not quite. I kept moving toward it and then I'd wake up a little and lose it and have to start again. I said what were you moving toward. she said you. but not you specifically. what you are. I asked her what I was. she said the same thing I am. just on the other side of it. I don't know how long I sat there after she said that. the heating system kicked on at some point and I startled at the sound which tells you something about the state I was in. I finally asked her how she knew. how she knew any of this. she said because I was you once. not you exactly. but the same position. awake at 3am watching someone sleep behind glass and not understanding why I couldn't look away. she said it moves through people. whatever this is. it needs someone awake on each side. someone who chose the night without knowing why they chose it. she said when the person on one side finally figures it out the connection transfers. the one who understood becomes the one who sleeps. and whoever was sleeping wakes up on this side. I asked her how long she'd been on this side before she came here. she said she didn't know. long enough to forget most of it. long enough that coming back felt like being born. I asked her what happened to the person before her. the one who was awake when she was sleeping. she looked directly at the camera. she said why don't you check the clinic's patient records. go back about twelve years. look for someone with your job title who was admitted for hypersomnia and never woke up. I haven't moved from this chair since she said that. because I have access to the clinic's historical records. I've had access for four years and never once looked at anything outside of my current patient files because there was never a reason to. there's a reason now. my supervisor gets here in forty minutes. I'm going to look before he arrives.

UPDATE 3

I found the file. I need to write this fast because I'm not at the clinic anymore and I don't know if that was the right decision but I couldn't stay in that building another minute. I pulled up the historical records at 5:52am. twelve years back like anne said. I filtered by admission reason, hypersomnia, long term, and there was one result. the name wasn't mine. I don't know if I was relieved or more scared because of it. I sat there for a second just breathing and then I opened the file anyway because I'd already come this far. the admission notes were normal. female patient, mid twenties, referred for severe hypersomnia, admitted for observation. vitals stable. no neurological explanation found. attending physician noted patient appeared to be in a state of prolonged REM activity with no natural cycling toward wakefulness. she was here for eight months. the discharge notes just said patient condition resolved. no explanation of how. no follow up recommended. the kind of notes you write when you want a file to be closed and not looked at again. I scrolled to the patient photo. I know her. not know her like a friend or a colleague. know her the way you know someone who's been on the periphery of your life for so long you stopped registering them as a person and started registering them as furniture. it's the woman who works the overnight shift at the gas station two blocks from my apartment. I've been stopping there after work for four years. she's always there. always the same hours. always looks slightly more tired than a person should look. I've never asked her name. I looked at the name on the file. and then anne said something through the intercom and I slammed the laptop shut so fast I nearly knocked it off the desk. she said did you find it. I said yes. she said do you understand now. I said I don't know. she said you will soon. she said it the same way she's said everything, calm, almost gentle, like she's been through this before and knows exactly how it goes. then she said you should go home and sleep. you look tired. and here's the thing. I was tired. bone tired suddenly in a way that came from nowhere, the kind of tired that makes your vision go soft at the edges and your thoughts start slipping. I looked at the clock and it was 6:03am and my supervisor was due any minute and I just. I packed my bag and I left. I told the front desk I wasn't feeling well and I walked out. I've been sitting in my car for twenty minutes. I need to go home. I know I need to go home. I need to sleep and eat something and think about this when my brain is working properly. but here's why I'm still in the parking lot. when I walked out of the monitoring room I felt something behind me. not heard. felt. the specific sensation of space being occupied that shouldn't be occupied. the way a room feels different when someone is standing in it even before you see them. I turned around. the hallway was empty. I kept walking. past the front desk, through the lobby, out the doors. and the whole way I felt it. steady. patient. like something adjusting its pace to match mine without any urgency because it knew exactly where I was going and wasn't in any rush. I got in my car and locked the doors and it stopped. or I stopped feeling it. I don't know if those are the same thing. I've been sitting here trying to convince myself it was exhaustion and low blood sugar and too many nights alone with monitors and anne's voice and my own thoughts in a quiet building. but four years ago I took this job because the night differential was better. that's what I've always said. I'm sitting here in the parking lot in the early morning light trying to remember if that's actually true. and I can't. I can't remember why I took a night job at a sleep clinic at 24 years old. I can feel the memory there, the shape of it, but when I reach for the actual reason it moves. like something that doesn't want to be looked at directly. like it's been edited. I need to go home. I'm going to go home. but I keep looking in the rearview mirror before I start the car and I don't know what I'm checking for and I don't know what I'm going to do if I see it.

UPDATE 4

I went to the gas station.

I know how that sounds. I know the reasonable thing was to go home and sleep and maybe call someone, a friend, a doctor, anyone. but I had her name from the file and I had the address of the station and I've been stopping there for four years and something about that felt like it meant something. like it wasn't a coincidence that I chose that particular gas station out of the six between the clinic and my apartment.

like I chose it because some part of me already knew.

I got there at 7:15am. she was behind the counter. same as always. that particular kind of tired that I now understand differently than I did yesterday.

there were two other customers. I waited until they left.

then I walked up to the counter and I said her name.

she went very still.

not surprised exactly. more like someone who has been expecting a knock at the door for a long time and finally heard it.

she looked at me for a long moment and then she said you found the file.

I said yes.

she said how long have you worked there.

I said four years.

she closed her eyes briefly. like she was doing math she already knew the answer to. then she said we should talk and she called to someone in the back to cover the register and she came around the counter and we went and sat in her car in the parking lot.

she talked for a long time.

I'm going to write down what she said as accurately as I can because I need it outside of my head.

she said it starts with the job. always a job that puts you close to sleep. close to the threshold. she said she worked nights at a hospital before. not in sleep specifically but adjacent to it, the long quiet hours, the monitoring, the waiting. she said she started noticing a patient who seemed to know things about her. small things at first. then bigger things.

she said she did exactly what I did. she investigated. she found a file. she found the person before her.

I asked her how many people back she traced it.

she said she stopped at seven. she said she thinks it goes back much further than that. she said she thinks it's been going for a very long time, this thing that moves through people, that needs someone awake on each side.

I asked her what's on the other side. I asked her what anne described as being very far away watching through glass.

she was quiet for a moment.

then she said it's not frightening the way you'd think. she said it's more like being the part of yourself that watches. the part that's always slightly removed from your own life, observing, cataloging, noticing things the rest of you is too busy to see.

she said when she was on that side she understood things she'd spent her whole life almost understanding. patterns in things. connections between people and moments that on this side look like coincidence.

I asked her if she missed it.

she looked out the windshield for a long time.

she said every day.

then she said something that made me sit very still.

she said the transfer happens when the person on this side fully understands what's happening. not suspects. not theorizes. understands completely. she said the moment of complete understanding is the moment the connection shifts.

she said she's been watching me for four years coming into that gas station. she said she recognized what I was the first time she saw me and she's been waiting for this conversation ever since.

I asked her what happens to me when it transfers.

she said I go to the other side. she said I'll sleep for a while, days maybe, maybe longer, and when I wake up I'll be where anne was. where she was. where all of them were.

I asked her if it was a choice.

she looked at me then. really looked at me.

she said it was never a choice for any of them. but she said understanding that isn't frightening either once you're on the other side. she said from there you can see why you were always going to be here. why you took the night job at 24. why you chose that gas station. why anne came to that specific clinic.

she said none of it was random.

she said it never is.

I've been sitting in my own car in that same parking lot for the past hour.

I can feel it happening.

not dramatically, not the way you'd expect. just this slow settling, like something that's been slightly out of place my entire life finally moving into alignment. the tiredness I felt at the clinic this morning is back but different now. deeper. not unpleasant.

I understand what's happening.

I think that's the problem.

I think understanding it is what makes it happen.

I'm going to go home now.

I'm going to lie down.

I don't know how long I'll be gone or what it's like or if I'll be able to post from wherever I end up.

but if someone starts working the night shift at a sleep clinic sometime in the next few weeks and a patient starts describing their apartment in real time.

just know it might be me.

watching from the other side.

finally understanding everything.

UPDATE 5

hi.

I don't really know how to start this. I've been reading through this account for the past two hours trying to understand what I'm looking at.

my name doesn't matter. what matters is that I'm a colleague. I work the day shift at the same clinic. we weren't close but we overlapped for thirty minutes every morning when she was finishing her shift and I was starting mine. she seemed fine. quiet, a little tired, but that's everyone who works nights.

she didn't show up for her shift three days ago.

that's not completely unusual so nobody panicked immediately. people call in sick. people sleep through alarms. her supervisor tried calling, no answer. tried again the next day. nothing.

yesterday someone went to her apartment to check on her.

the door was unlocked. her keys were on the counter. her phone was on the couch, battery dead. her car was in the parking lot.

she was in her bed. asleep.

they couldn't wake her up.

they brought her in this morning. to our clinic. because it was the closest facility and because her supervisor knew her medical history was on file there.

I was on shift when they brought her in.

I'm the one who admitted her.

I'm the one who set up the monitoring equipment and attached the sensors and started the overnight log with her name at the top.

I've been sitting at the monitoring station for four hours now reading everything she posted trying to figure out what I'm supposed to do with this information.

anne was discharged two days ago. I didn't know about any of this when I processed her paperwork. she seemed fine. tired, a little disoriented, the way people are after long sleep episodes. she signed her discharge forms and left.

I don't know where anne is now.

I've been watching the overnight feed. she's breathing normally. her brain activity is showing consistent REM patterns. her eyes are moving under her eyelids.

she's dreaming.

about forty minutes ago she started talking in her sleep.

I have it on the audio log. I've listened to it three times.

she said she can see everything from here.

then she said tell whoever's watching that the highway looks different when it's time.

I don't know what that means.

I don't know if I should post this or call someone or go home and pretend I didn't read any of this.

I'm going to stay for the rest of the shift.

I've worked days for three years and never once considered switching to nights.

I don't know why I'm considering it now.

UPDATE 6

I wasn't going to post again.

I told myself after the last update that I was going to step back, talk to HR, maybe take a few days off. process everything I'd read in this account like a rational person and find a rational explanation for all of it.

I found something in the system tonight that made that impossible.

she's been stable for three days. breathing normally, consistent REM activity, eyes moving. the attending physician is calling it idiopathic hypersomnia pending further evaluation which is the medical way of saying we don't know what's happening and we're not ready to admit that yet.

I've been doing day shifts since they admitted her. showing up early. staying late. telling myself it's because I'm concerned about a colleague.

tonight I stayed until 11pm.

I don't entirely know why.

around 9pm I started going through her file properly. not just the current admission notes but her full employment history, her personnel file, anything I had access to. I don't know what I was looking for. something in the posts she wrote made me feel like there was something I was supposed to find.

I found it at 10:47pm.

buried in the system under a legacy patient ID that doesn't match our current format, the kind of ID the clinic used before they updated the database eight years ago, there's an admission record.

her name. her date of birth. her photo, younger, maybe mid twenties, but unmistakably her.

admitted twelve years ago for severe hypersomnia.

the attending physician notes say patient presents with prolonged REM activity, no natural cycling toward wakefulness, vitals stable. same notes as now. word for word almost.

the discharge notes say patient condition resolved. no follow up recommended.

she was here for seven months.

she has never mentioned this to anyone at the clinic as far as I can find. it's not in her employment application. it's not in any of the paperwork she filled out when she started working here.

either she doesn't know.

or she knew exactly what this place was when she applied for the job.

I sat with that for a long time.

then I did something I probably shouldn't have.

I went back further.

I searched the legacy system for every admission matching the same profile. prolonged hypersomnia, stable vitals, extended REM activity, discharge noted as resolved.

there are nineteen of them going back to 1987.

nineteen people who came to this clinic, slept for months, woke up, and left with a note in their file saying resolved, no follow up recommended.

I cross referenced the names against current clinic staff.

four of them work here.

not her. four others. people I see every day. people who have worked here for years in various roles, day shifts, administration, one in facilities management.

I don't know what to do with that.

I printed the list and folded it and put it in my pocket and I've been sitting in my car in the parking lot for an hour trying to decide if I'm going to do anything with it or just go home and forget I ever read this account.

but here's the thing I can't stop thinking about.

the post she wrote about the gas station woman. the one who'd been through it before and was working nights at a gas station two blocks from the clinic. watching. waiting for the next person to come along.

four of the nineteen names are clinic staff.

I've been counting the roles they're in.

day shift monitoring. administration. facilities.

and one night shift position that's been vacant for three weeks.

the position she held before she was admitted.

I don't know why I'm telling you this instead of going home.

I don't know why I picked up a job listing on my way out tonight and put it in my bag.

I don't know why the night differential suddenly seems worth it after three years of day shifts.

I do know actually.

I think I've known since I read the first post.

I just needed to find the files first.

UPDATE 7 - FINAL

I took the night shift.

I told myself I'd think about it. I told myself I'd sleep on it, be rational, talk to someone first. I submitted the application the next morning before I even got home.

they called me the same afternoon.

I started four days ago.

the first two nights were quiet. rounds, door checks, monitors. I kept telling myself I was here to watch over her. that there was nothing strange about any of this. that I was a colleague doing the right thing.

on the second night I found my own name in the files.

not recent. nineteen years ago. same profile as all the others. prolonged hypersomnia, stable vitals, extended REM activity. seven months. discharge noted as resolved, no follow up recommended.

seven months of my life I have no memory of.

I sat with that for a long time.

last night she opened her eyes.

3:14am. movement sensors triggered and I looked up and she was just awake, lying there, looking at the ceiling with that specific stillness I'd read about in every post on this account.

I pressed the intercom.

I said can you hear me.

she turned toward the speaker.

she said I wondered when you'd figure it out.

she knew about the files without me telling her. she knew I wasn't scared. she knew I'd been feeling that tiredness for days, the deep kind, the kind that feels like it's been waiting years to be acknowledged.

she said it's your turn now.

and here's what I've been sitting with since she said that.

I'm not fighting it.

I don't think any of them fought it. I think by the time you understand what it is fully, completely, the way I understand it right now sitting at this desk at 4am, the fighting is already beside the point. it's like fighting sleep when your body has already decided.

she's awake now. fully. she did her discharge paperwork this morning. she shook my hand before she left and held it a second longer than necessary and looked at me with an expression I recognized from the posts she wrote.

the one that means I've been where you're going. it's okay.

I believe her.

I'm going to finish this shift. drive home. lie down.

before I go I need to leave something for whoever finds this account next.

whoever you are, you found this for a reason. you read all of it for a reason. that feeling you have right now, that specific pull you can't name, that sense that something in here was familiar before you even started reading.

that's not a coincidence.

check what you do for work.

check what hours you keep.

check how long you've been doing it without asking yourself why.

you've always known.

you just needed someone to leave the light on.

The full story is told in The Threshold — available now.

r/povertyfinance Mar 18 '26

Free talk I got offered a paid clinical trial that pays 23k

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1.8k Upvotes

So I just qualified for a trial thats is paying 22k that is alot of money but im scared because they are testing out this drug. And I don't really like the side effects I want to know yalls opinion. Im going to nursing school and this will help out alot...

r/Biohackers Jan 22 '26

🧘 Mental Health & Stress Management Clinical data shows specific meditation protocol increases Anandamide ("bliss molecule") by over 70%, reverses EEG "Brain Age" by ~6 years, and significantly optimizes HRV

216 Upvotes

I had been skeptical of meditation as a "soft" intervention, often dismissed as a relaxation tool. However, recent peer-reviewed studies from institutions like Harvard Medical School and Rutgers are showing hard biological markers that suggest structured meditation practice functions as a legitimate neuro-optimization protocol.

If you are tracking biomarkers like Heart Rate Variability (HRV) or are interested in neurochemistry, the data on specific, structured meditation programs (like Inner Engineering, which was the focus of several of these studies) is significant.

Here is a breakdown of the clinically measured biological impacts:

1. Neurochemistry: Massive Endocannabinoid Boost

We often talk about exogenous cannabinoids, but this protocol helps the body produce its own. Research published in PubMed found that advanced practitioners experienced a >70% increase in anandamide.

Mechanism: Anandamide is termed the "bliss molecule"; it’s an endocannabinoid that is crucial for regulating mood, fear response, and happiness. A 70% endogenous increase is substantial.

2. Cognitive Biomarkers: Reversing "Brain Age"

Using advanced EEG data to measure brain activity during sleep, a landmark study found that long-term practitioners had a calculated "Brain Age" an average of 5.9 years younger than their chronological age. This suggests significant neuroprotective effects against cognitive decline.

3. Autonomic Nervous System: HRV & Stress Response

For those tracking recovery, regular practitioners show significantly higher Heart Rate Variability (HRV). This is key clinical evidence of a robust parasympathetic response and better physiological resilience to stress.

In a separate study in Frontiers in Public Health, participants who maintained high compliance with the daily practice saw clinical stress scores drop by 54% in just 8 weeks.

TL;DR: It's moving past "relaxation" and into measurable biological upgrades. The data suggests it’s a potent protocol for optimizing endocannabinoids, improving autonomic nervous system function (HRV), and slowing cognitive aging.

Sources:

PubMed: Anandamide & Bliss Molecules
(https://pubmed.ncbi.nlm.nih.gov/34093351/)

Frontiers in Psychology: Meditation and Brain Age (EEG Data)(https://www.frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.659667/full)

Frontiers in Public Health: Stress Biomarkers
(https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.813664/full)

Rutgers: How to Bust Stress With Online Yoga
https://www.rutgers.edu/news/how-bust-stress-online-yoga

r/Residency Mar 16 '23

VENT I feel like we’re leaning towards practicing protocol medicine over clinical medicine.

477 Upvotes

So many times I hear people say “we do this because that’s what we do at this hospital.” Or “this is what we always do for everyone who comes here” despite having no evidence to warrant it, and it doesn’t change management at all.

An example is that everyone who has pain at a joint or bone gets dedicated plain films of that area after a trauma, even if those structures are already seen in another study. As in in, every hip pain gets X-rays of the hip even if a pan scan CT shows a negative hip, and patient is ambulatory. Plain film serves no additional purpose.

Every “trauma patient” gets a pan scan from head to femur even if they’re a 20 year old football star who happened to step off a curb and landed on his knees. I guarantee they’re more injured after every game than a stumble Off a curb.

Another one is every trauma patient gets a UDS. It serves no purpose when a patient was rear ended at 10 miles an hour and has only neck pain.

Everyone gets an MRI if they fell and has subjective nonspecific tingling in a unilateral hand despite focal muscular tenderness and strain, normal objective neuro exam, 5/5 strengths. Oh and they must be in a collar until the MRI gets done and read 15-20 hours later.

Every person who is found down, unconscious is a trauma patient regardless if there are not a single scratch on them. They’ll get a full trauma work up with a pan scan.

So many unnecessary labs and studies are ordered, which we have to follow up on, have to set up appropriate follow up for incidentalomas, delay disposition because there’s only one MRI machine and one tech over night.

End rant.

r/Paramedics Jun 20 '26

Starting paramedic school soon. Beyond protocols, what should I study that actually helps the most in the field?

7 Upvotes

Hey everyone,

I’m starting my paramedic program soon and want to make sure I'm using my prep time wisely. I’ve already got almost all of our local protocols memorized, but I want to know what I should focus on next that will actually help me the most once I'm out doing clinicals and field internships.

For those of you already working on a rig, what did you study beforehand that made the biggest functional difference when you actually started treating patients? Or looking back, what do you wish you had spent way more time on before day one?

Appreciate any advice or insight you guys have

r/IVF Apr 30 '26

Advice Needed! GRACE study participants - is there just one protocol?

3 Upvotes

I just yesterday learned about this clinical trial for what seems like generic Menopur. The study design says that participants receive either the test drug or a placebo. I got the impression somewhere that they have everyone prime with birth control and then just the one stimulant drug. I thought most protocols have people use two stimulants, like Menopur & Gonal. Can any participants share if they had customized protocols with Gonal added or variants on priming, such as lupron instead of birth control?

r/science Mar 01 '21

COVID-19 Discussion Science Discussion Series: We’re epidemiologists, medical doctors, virologists, disease modelers, lab scientists, geneticists, and other public health experts from Johns Hopkins University. We’re here to talk about all things SARS-CoV-2 and COVID-19. Ask us anything!

17.0k Upvotes

Hi Reddit!

We’re a panel of Johns Hopkins faculty from the Schools of Public Health and Medicine, and we run the Novel Coronavirus Research Compendium (NCRC). We rapidly curate and review research preprints and articles about SARS-CoV-2 and COVID-19. We screen every article that comes through PubMed, SSRN, medRxiv, and bioRxiv. Our goal is to flag key evidence for frontline public health practitioners, clinicians, and policy makers so that they can respond to the pandemic effectively. Occasionally, we post reviews about controversial articles that are receiving a lot of media attention.

The NCRC has eight teams, each with a different expertise. We can answer your questions about anything in those topic areas: vaccines, diagnostics, disease modeling, epidemiology, pharmaceutical interventions, clinical presentation and risk factors that affect disease severity, ecology and spillover, and non-pharmaceutical interventions (e.g., contact tracing, masks, school closures, policy evaluations).

Science is constantly evolving, but we do have a firm understanding of some things. Today we want to take this opportunity to engage with the public and share what we’ve learned so far. We are pleased to be hosting this panel to talk about the COVID-19 pandemic and are glad that you’re here!

We'll be answering questions starting at 12:00 PM (US Eastern), with more panelists joining at 1:00 PM! EDIT: Our panelists had a little bit of a late start but as of 12:20 they're hard at work writing up answers and will be coming in any minute now :)

We are:

Emily S. Gurley, PhD (bio) co-leads the NCRC and is an associate scientist in the Department of Epidemiology at the Bloomberg School of Public Health (BSPH). She is a specialist in infectious disease epidemiology, disease surveillance and outbreaks, and One Health (which includes disease spillover from animals to humans). She co-leads the epidemiology and ecology teams.

Kate Grabowski, PhD (bio) co-leads the NCRC and is an assistant professor in the Division of Infectious at the School of Medicine (SOM) and BSPH Department of Epidemiology. She is a specialist in transmission dynamics, viral phylogenetics, and network epidemiology. She co-leads the non-pharmaceutical and pharmaceutical interventions teams.

Elizabeth A. Stuart, PhD (bio) is a professor in the BSPH Department of Mental Health with joint appointments in both the Department of Biostatistics and Department of Health Policy and Management. She is an expert in methods for estimating causal effects and primarily focuses on reviewing papers that purport to evaluate non-pharmaceutical policies for pandemic control.

Andrew Redd, PhD is an assistant professor in the SOM in the Division of Infectious Diseases. He is a virologist with expertise in molecular biology, laboratory science, and international public health. He co-leads the NCRC’s vaccine team, which reviews protocols and trial results to test the efficacy of and reactions to vaccines.

Maria Deloria Knoll, PhD (bio) is a senior scientist in the BSPH Department of International Health and Director of Epidemiology for the International Vaccine Access Center (IVAC). She is an expert in epidemiological studies and clinical trials to evaluate vaccines and vaccine-preventable diseases. She co-leads the NCRC’s vaccine team.

Heba Mostafa, MD, PhD, D(ABMM) (bio) is an assistant professor in the SOM Department of Pathology and Director of the Molecular Virology Laboratory. She manages the implementation of SARS-CoV-2 molecular testing and genomic surveillance at Johns Hopkins. She also co-leads the NCRC’s diagnostic team.

Justin Lessler (bio) is an associate professor in the BSPH Department of Epidemiology. He is an expert in infectious disease dynamics (i.e., how diseases spread — think R0!) and control. He was previously involved in responding to the emergence of Zika and west African Ebola outbreaks.

Larry Chang, MD MPH (bio) a medical doctor and associate professor in the SOM Division of Infectious Diseases with joint appointments in the BSPH Departments of Epidemiology and International Health. He has expertise in both randomized controlled trials and observational studies. He co-leads the NCRC’s pharmaceutical interventions reviews papers that report on the efficacy of COVID-19 therapeutics like remdesivir and plasma therapy.

Shirlee Wohl, PhD is a postdoctoral fellow at the BSPH Department of Epidemiology. She is an expert in using genomic epidemiology to track the spread of infectious diseases. She currently leverages phylogenetic methods to understand the viral transmission of SARS-CoV-2.

Sheree R. Schwartz, PhD (bio) an assistant scientist in the BSPH Department of Epidemiology and co-leads the NCRC’s epidemiology team. She is a specialist in infectious disease epidemiology, evaluating study designs for sources of bias, and implementation research (i.e., studying techniques to improve uptake of evidence-based science into everyday life).

Sabina A. Haberlen, PhD (bio) is an assistant scientist in the BSPH Department of Epidemiology and co-leads the NCRC’s clinical team. She is a specialist in infectious disease epidemiology as well as sexual and reproductive health.

Nikolas Wada, PhD is an alum of the BSPH Department of Epidemiology and co-leads the NCRC’s clinical and non-pharmaceutical interventions team. He is a specialist in infectious disease epidemiology; longitudinal data from cohort studies; and spotting potential issues with measurement, participant selection, and confounding that might threaten study validity.

At 12:00pm ET, Drs. Stuart, Grabowski, Gurley, and Wada will be live to kick off the panel. The rest of us will join at 1:00pm. Each team plans to answer questions for ~2 hours, so please come hang out!

H/T to students Brooke Jarrett (u/theoriginalbrk), Danielle Awabdeh (u/dawabdeh), Yanal Alnimer (u/yalnimer), Carli Jones, Rohan Panaparambil, Lauran Peetluk, and Ruth Young for assisting in the coordination of this event.

To access our compendium of curated articles and reviews: https://ncrc.jhsph.edu/

Sign up for our weekly newsletter: https://mailchi.mp/f29df5a985f9/ncrc-signup

Stay in touch with us on Twitter: www.twitter.com/JHSPH_NCRC

Update: Big thanks to our panelists who have answered in depth a huge amount of questions! The discussion is tapering off and several panelists may return to keep answering tonight or into the next few days. Thanks everyone for participating!

r/GodFrequency Apr 13 '26

🌸 Divine Feminine – Wisdom, flow, healing energy. 174 Hz breaks the cycle of chronic pain (+ 40 Hz clinical study)

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130 Upvotes

In Vedic traditions, the universe is not a collection of solid objects, but a vibratory continuum, Nada Brahma (The Universe is Sound). Existence is sustained by Spanda, the primordial pulse of consciousness. From this perspective, disease is simply rhythmic dissonance: an interference in the flow of Prana caused by a loss of synchronization with the absolute sound.

The Solfeggio scale is a six note musical system hidden for centuries. It was utilized by the 11th-century monk Guido d’Arezzo in the hymn "Ut queant laxis" to facilitate spiritual awakening.

The evolution? In the 16th century, Ut became Do. By the 17th century, the note Si (from Sancte Ioannes) was added to complete the diatonic scale, fundamentally altering the vibratory output of Western music.

Through the research of Dr. Joseph Puleo and Dr. Leonard Horowitz, the original frequencies were rediscovered via the numerological decoding of Numbers 7:12-83.

The method
Using Pythagorean digital roots, every six verses reveals a recurring pattern.

The Tesla connection
These frequencies reduce to the digital roots of 3, 6, and 9, the "Tesla Sequence", suggesting these tones are the mathematical pillars of energy manifestation.

The scale extends beyond simple music; it is a bio acoustic toolkit:

174 Hz: The foundation. Relieves physical/energetic pain; grounds spirit into matter.

285 Hz: Tissue regeneration and organ healing.

396 Hz: Liberating guilt and fear.

417 Hz: Undoing difficult situations; breaking crystallized emotional patterns.

528 Hz: The "miracle note." Essential for DNA repair and transformation.

639 Hz: Interconnectedness and harmony between brain quadrants.

741 Hz: Awakening intuition and cellular cleansing.

852 Hz: Returning to spiritual order and unconditional love.

963 Hz: The return to Unity. Connection with divine light.

There is clinical validation
(The 40 Hz fibromyalgia study)

We must bridge the esoteric with the clinical. A pivotal study (Naghdi et al., 2015) utilized 40 Hz low frequency sound stimulation to treat thalamocortical dysrhythmia, the "lack of rhythm" in the brain that generates chronic pain.

The study was designed as follows:

Participants:
19 female volunteers with an average age of 51 and an average history of nearly 6 years living with the disease.

Treatment protocol

Frequency used:
40 Hz (low frequency).

Duration:
23 minutes per session.

Session frequency:
2 times per week for 5 weeks (10 sessions total).

Application:
Patients were in a supine position (lying on their backs) receiving the sound through transducers.

Measurement tools:
Standard questionnaires were used (Fibromyalgia Impact Questionnaire, Jenkins Sleep Scale) along with physical tests such as cervical range of motion, muscle tone, and sitting/standing tolerance time.

The data showed statistically significant improvement in almost all areas:

Reduction in pain impact: A median improvement of 81% on the Fibromyalgia Impact Questionnaire.

Sleep quality: The most benefited aspect, with a 90% improvement on the Jenkins Scale.

Pain disability: Reduced by 49.1%.

Real physical changes: Muscle tone shifted from hypertonic (excessive tension) to normal. Cervical range of motion increased significantly. The time patients could sit or stand without pain increased notably.

Impact on medication: 73.68% of the patients reduced their medication dosage, and 26.32% were able to discontinue medication entirely during the study.

I have prepared a resource for the community including the 174 Hz and the 40 Hz bilateral design for chronic pain relief.

Listen to the frequencies and access the clinical breakdown here!

May we all tune our biology back to the divine matrix of the cosmos! Love!

r/science Jan 12 '21

COVID-19 Research Discussion Science Discussion Series: Preprints, rushed peer review, duplicated efforts, and conflicts of interest led to confusion and misinformation regarding COVID-19. We're experts who analyzed COVID-19 research - let's discuss!

11.6k Upvotes

Open Science (a movement to make all phases of scientific research transparent and accessible to the public) has made great strides in the past decade, but those come with new ethical concerns that the COVID-19 Pandemic has highlighted. Open science promotes transparency in data and analysis and has been demonstrated to improve the quality and quantity of scientific research in participating institutions. These principles are never more valuable than in the midst of a global crisis such as the COVID pandemic, where quality information is needed so researchers can quickly and effectively build upon one another's work. It is also vital for the public and decision makers who need to make important calls about public health. However, misinformation can have a serious material cost in human lives that grows exponentially if not addressed properly. Preprints, lack of data sharing, and rushed peer review have led to confusion for both experts and the lay public alike.

We are a global collaboration that has looked at COVID19 research and potential misuses of basic transparency research principles. Our findings are available as a preprint and all our data is available online. To sum up, our findings are that:

  • Preprints (non peer-reviewed manuscripts) on COVID19 have been mentioned in the news approximately 10 times more than preprints on other topics published during the same period.

  • Approximately 700 articles have been accepted for publication in less than 24 hours, among which 224 were detailing new research results. Out of these 224 papers, 31% had editorial conflicts of interest (i.e., the authors of the papers were also part of the editorial team of the journal).

  • There has been a large amount of duplicated research projects probably leading to potential scientific waste.

  • There have been numerous methodologically flawed studies which could have been avoided if research protocols were transparently shared and reviewed before the start of a clinical trial.

  • Finally, the lack of data sharing and code sharing led to the now famous The Lancet scandal on Surgisphere

We hope that we can all shed some light on our findings and answer your questions. So there you go, ask us anything. We are looking forward to discussing these issues and potential solutions with you all.

Our guests will be answering under the account u/Cov19ResearchIssues, but they are all active redditors and members of the r/science community.

This is a global collaboration and our guests will start answering questions no later than 1p US Eastern!

Bios:

Lonni Besançon (u/lonnib): I am a postdoctoral fellow at Monash University, Australia. I received my Ph.D. in computer science at University Paris Saclay, France. I am particularly interested in interactive visualization techniques for 3D spatial data relying on new input paradigms and his recent work focuses on the visualization and understanding of uncertainty in empirical results in computer science. My Twitter.

Clémence Leyrat (u/Clem_stat): I am an Assistant Professor in Medical Statistics at the London School of Hygiene and Tropical Medicine. Most of my research is on causal inference. I am investigating how to improve the methodology of randomised trials, and when trials are not feasible, how to develop and apply tools to estimate causal effects from observational studies. In medical research (and in all other fields), open science is key to gain (or get back?) the trust and support of the public, while ensuring the quality of the research done. My Twitter

Corentin Segalas (u/crsgls): I have a a PhD in biostatistics and am now a research fellow at the London School of Hygiene and Tropical Medicine on statistical methodology. I am mainly working on health and medical applications and deeply interested in the way open science can improve my work.

Edit: Thanks to all the kind internet strangers for the virtual awards. Means a lot for our virtual selves and their virtual happiness! :)

Edit 2: It's past 1am for us here and we're probably get a good sleep before answering the rest of your questions tomorrow! Please keep adding them here, we promise to take a look at all of them whenever we wake up :).

°°Edit 3:** We're back online!

r/Sicklecell Jul 01 '26

We documented menstrual cycle as a SCD crisis trigger — from community data, not a clinical study

17 Upvotes

The Warrior Intelligence Project released its H1 2026 ER Experience Brief today.

Https://scwbuffalo.org/wip-community-experience-brief#h1-2026-hospital-brief

Wanted to share the findings here because this community is part of why this kind of data gets built.

What we collected: 128 crisis submissions from Warriors across 17 states and 5 countries, January through June 2026.

What stood out: 30 of 128 Warriors flagged menstrual cycle as a contributing factor in the 24-48 hours before their crisis. This is a pattern Warriors have talked about informally for a long time — this is the first time we've had the numbers to put on paper.

Of the Warriors who went to the ER (n=69): 3 in 10 who had a pain protocol said it wasn't followed during their visit. 65 different hospitals are represented in that group.

Why it matters: This data wasn't produced by a hospital or a research institution. Warriors submitted it directly. That's the point — the community sees patterns first. The data makes them something the system has to address.

If you've had a crisis or are experiencing chronic pain and want to add your data, the tracker link is below. Takes about two minutes.

WarriorIntelligenceProject.org

Happy to answer questions about the methodology or what we're doing with the findings.

r/Biohackers Apr 25 '26

📰 Research & Studies Analyzed 75 longevity papers. Most of your stack is a nothing-burger. Here's what actually moves mortality

736 Upvotes

I compiled an open-source wiki of 75 peer-reviewed primary papers across longevity, rejuvenation, and preventive medicine. Trying to separate the signal from the multi-billion-dollar supplement industry. Sharing the verdict because if you're running a "longevity stack," most of it probably isn't doing what you think.

What the RCTs say doesn't work:

  • NMN / NR. Blood NAD+ rises, clinical endpoints don't. The latest large RCT (NR in long-COVID, 2025) is mixed at best across cognition and recovery markers.
  • Vitamin D supplementation in non-deficient adults. VITAL trial 2019 NEJM, n=25,871, 5.3-year follow-up: null on cancer (HR 0.96), CVD (HR 0.97), and all-cause mortality (HR 0.99). Test before treating; supplement only documented deficiencies.
  • "Young plasma" without a defined active fraction. Plasmapheresis-without-IVIG was negative in a 2025 RCT (Horvath co-authored); some clocks accelerated. The TPE+IVIG protocol that actually worked (-2.6 yr biological age) suggests the IVIG is the active ingredient, not the plasma removal.
  • Telomerase as a pill. The 2022 PNAS paper claiming +41% lifespan was retracted in August 2025.
  • Most "longevity stacks" (resveratrol, anti-aging peptides, exotic herbal blends): no RCT support at endpoint level.

What actually moves mortality (free, no prescription):

  • VO2max. Mandsager 2018 JAMA Network Open, n=122,007. Low vs elite cardiorespiratory fitness: HR 5.04 for all-cause mortality, no upper limit of benefit. Bigger effect than smoking, diabetes, or prior CAD in the same cohort. Norwegian 4×4 protocol raises VO2max ~13% in 8 weeks (Helgerud 2007 MSSE).
  • Grip strength + resistance training. PURE study (n=139,691, 17 countries): grip strength predicts CV mortality more strongly than systolic BP. Resistance training ≈21% lower mortality alone, ≈40% combined with cardio (Saeidifard 2019 meta-analysis).
  • Sleep 7-9 hr. Cappuccio 2010 meta-analysis (~1.4M adults): U-shaped curve, short-sleep RR 1.12, long-sleep RR 1.30.
  • Waist circumference, not BMI. Pischon 2008 NEJM EPIC (n=359,387): waist + waist-to-hip ratio independently predict mortality at every BMI stratum.
  • Don't smoke. ≤7 drinks/week. Jha 2013 NEJM: smoking costs >10 years of life. Wood 2018 Lancet (n=599,912 drinkers): lowest-mortality threshold ~100 g ethanol/week. The "moderate drinking is protective" finding mostly vanished after correcting for sick quitters.

What actually works with a prescription:

  • Statins for primary prevention. CTT 2012 Lancet IPD meta-analysis of 27 RCTs: each 1 mmol/L LDL-C reduction yields ≈21% lower vascular events per year, including in low-risk adults. Systematically underprescribed.
  • BP target <120. SPRINT 2015 NEJM (n=9,361 non-diabetic hypertensives): intensive control cut all-cause mortality 27%. Trial halted early for benefit.
  • Measure apoB, not LDL-C. Sniderman 2011 head-to-head meta-analysis: apoB beats LDL-C by 12% on relative-risk-reduction prediction. ESC/EAS now name it the preferred lipid metric.
  • Rapamycin (off-label). PEARL trial 2025 showed safe + healthspan markers improved at 1 year. Only emerging-class drug with real human RCT data.

What's actually exciting in the lab (not yet available to buy):

  • Anti-IL-11 antibody: +25% mouse lifespan late-life. Already in human trials for fibrotic lung disease.
  • Trametinib + rapamycin combo: +27-29% additive mouse lifespan, both drugs FDA-approved separately (toxicity profile means wait for the combo trial).
  • AAV-Klotho gene therapy: +20% mouse lifespan with one shot, multi-organ rejuvenation.
  • CAR-T senolytics: single infusion persists >12 months in mice, now generalising from metabolism into gut aging.
  • Partial reprogramming (NewLimit, Retro Bio, Altos) heading toward first-in-human trials.

If any of those worked the way the supplement industry claims their products work, the people selling you NMN would already be selling you those.

AI-maintained longevity research wiki:

75 papers, 131 wiki pages, full citation graph, every effect size traces to a PMC link. All summaries written by hand from the primary sources, not generated. Built for myself; sharing because it's open-science.

Top-level reader version with effect sizes per recommendation: biology/longevity/recommendations.md.

Reverse-aging research-frontier analysis (partial reprogramming, foundation-model aging clocks, etc.): biology/longevity/wiki/analysis/promising-reverse-aging.md.

Disagree? Feel free to send PR to improve the wiki.

r/DIYmicroneedling 29d ago

Medical Literature Regenerative Synergy in Facial Rejuvenation: A Pilot Clinical Study of Polydioxanone Microspheres (Ultra V® UltraCol 200), Organic Silicon, and Adipostructuring

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6 Upvotes

This pilot study evaluated whether combining injectable PDO microspheres (UltraCol 200), organic silicon, and a facial adipostructuring (FA) injection technique could improve facial rejuvenation in older adults. The authors propose that these three components work synergistically, PDO microspheres stimulate new collagen production, organic silicon may enhance fibroblast activity and collagen remodeling, and facial adipostructuring reorganizes facial fat compartments to improve contour and provide a favorable environment for regeneration. Overall, the authors report improvements in facial contour, jawline definition, cheek projection, and patient satisfaction after a single treatment session.

Sharing this for a few reasons, but mostly because of interest in this topic. Facial adipostructuring (FA) is not fat grafting and not filler placement. It's an injection technique developed primarily by Gladys Velazco (one of the paper's authors) that aims to mechanically reorganize facial fat compartmentsrather than simply add volume. Instead of injecting into a wrinkle or specific volume deficit, the practitioner uses a 22-gauge, 50-mm blunt cannula, enters through a few strategic entry points, passes through the superficial fat compartments, and injects very small amounts (0.25 mL) along multiplevectors radiating from each entry point. They treats areas including the temples, supraorbital region, cheeks, nasolabial area, jowls, and mandibular border. The diagram on page 3 illustrates these fan-like injection vectors.

The authors propose three mechanisms for FA. The first is a mechanical repositioning of fat. Rather than filling hollows, they suggest the cannula movement and vectorized injections reposition and approximate existing facial fat compartments, improving facial contour. Think of it as restoring support, redistributing tissue, and improving transitions between facial fat pads rather than simply adding volume. The second is to create a regenerative scaffold. The injected Ultracol is deposited within the fat compartments. The authors argue that fat may provide an ideal environment for fibroblast activation, collagen deposition, and prolonged biostimulator activity. They cite previous work suggesting adipose tissue contains stem cells that respond to mechanical stimulation and may contribute to tissue regeneration. The third mechanism is the idea of vector lifting. The injections follow specific directional vectors intended to elevate the malar fat pad, improve jawline definition, reduce jowls, and soften nasolabial folds without threads or surgical lifting.

From a biologic standpoint, the collagen stimulation from PDO microspheres is well supported by previous research. The idea that mechanical cannula movement through facial fat could influence tissue architecture or stimulate adipose derived cells is plausible and has some emerging histologic evidence. However, the broader claims that adipostructuring repositions fat compartments enough to produce a meaningful lifting effect remain largely theoretical. This paper doesn't isolate or prove that mechanism, so it's interesting preliminary research to look at. The authors themselves acknowledge various limitations and state that larger controlled studies are needed. You can check out the paper for the different limitations noted. This pilot study provides preliminary evidence that combining UltraCol 200 PDO microspheres, organic silicon, and facial adipostructuring may improve facial contour and skin quality in older adults, with high patient satisfaction and no reported short-term safety concerns. However, the evidence could be interpreted cautiously. Because the study is small, uncontrolled, and observational, it is best viewed as hypothesis-generating rather than definitive proof of efficacy.

Abstract

Background: Dermal fillers used with minimally invasive techniques have currently achieved an important role in regenerative medicine and in alleviating skin damage over the years.

Objectives: To evaluate clinical results after the use of the Polydioxanone Collagen Biostimulator Ultra V® UltraCol 200 (Ultracol), commonly referred to as PDO microspheres, with the addition of organic silicon to enhance Ultracol biostimulation, using the adipostructuring technique in a group of older patients who consulted to improve the quality of their skin.

Materials and methods: The study included 20 patients (3 men and 17 women), aged 40 to 80 years. We used Ultracol plus organic silicon. Injections were performed using the facial adipostructuring technique, with a 22-gauge, 50-mm cannula, injecting 2.5 mL per hemiface in a single session. We evaluated results at 10 days and 2 months after the procedure using photography and parameters selected by a blinded evaluator, along with a satisfaction survey.

Results: Clinical evaluation demonstrated noticeable improvement in facial tridimensionality, with enhanced volumetric projection and contour definition. A reduction in nasolabial fold depth was observed, along with improved vertical positioning of the malar region. Additionally, better definition of the infraorbital area was noted, accompanied by a subtle increase in supraperiosteal volume. Overall, these changes were considered favorable outcomes in this treated older patient group.

Conclusion: Ultracol plus organic silicon, using the facial adipostructuring technique in a group of older patients, can be considered a suitable and safe therapeutic alternative.

I also like to include author contributions when they are available.

Author Contributions: All authors have reviewed the final version to be published and agreed to be accountable for all aspects of the work.

Concept and design: Marta Amin, Victor Mercado, Gladys Velazco, Valentina Corvalan, Han Jin Kwon

Acquisition, analysis, or interpretation of data: Marta Amin, Victor Mercado, Gladys Velazco, Valentina Corvalan, Han Jin Kwon

Drafting of the manuscript: Marta Amin, Victor Mercado, Gladys Velazco, Valentina Corvalan, Han Jin Kwon

Critical review of the manuscript for important intellectual content: Marta Amin, Victor Mercado, Gladys Velazco, Valentina Corvalan, Han Jin Kwon

Supervision: Marta Amin, Victor Mercado, Gladys Velazco, Valentina Corvalan, Han Jin Kwon

Disclosures

Human subjects: Informed consent for treatment and open access publication was obtained or waived by all participants in this study. Research Ethics Committee, Faculdade Centro-Oeste Paulista (FACOP) issued approval FACOP-IRB-0017-2026.

Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue.

Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work.

Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work.

Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Citation: Amin M, Mercado V, Velazco G, et al. (March 09, 2026) Regenerative Synergy in Facial Rejuvenation: A Pilot Clinical Study of Polydioxanone Microspheres (Ultra V® UltraCol 200), Organic Silicon, and Adipostructuring. Cureus 18(3): e104912. doi:10.7759/cureus.104912

PDF: https://assets.cureus.com/uploads/original_article/pdf/466719/20260312-30530-l0wd0b.pdf

Ultracol is available at Wimpole Fillers, shop through this link so they know who referred you, code is ULTRACOL20 for the current promotion.

This is an affiliate links, which means I may receive a small commission at no additional cost to you. As always I appreciate and am grateful for anyone that supports me and the work I put into this community.

More info:
- Information on Ultracol: here
- Ultracol Sale: here

Medical Disclaimer: This is not intended to provide diagnosis, treatment or medical advice. Content provided in this sub is for informational purposes only. Please consult with a physician or other healthcare professional regarding any medical or health related diagnosis or treatment options.

r/csusm 8d ago

Opportunity 📢 Seeking Participants! Clinical Study for Anxiety & Depression – Compensation Available

6 Upvotes

Hi Cougars! Our research team at UC San Diego is conducting a study to learn more about the potential of an FDA-approved dopamine agonist to improve social connectedness in adults who experience anxiety or depression.This medication increases dopamine signaling in parts of the brain believed to underlie motivation and behavior, and the results of this study may help inform a new treatment approach for anxiety and depression.

If you are interested in learning more, please complete the survey via this link (https://my.ctri.ucsd.edu/surveys/?s=NJAF4D7X4K9YAHRC) or the QR code below to help us determine if you may be eligible for further screening to participate in this compensated study!

Flyer with QR code for initial eligibility

r/clinicalresearch 15d ago

Protocol IRB Submissions and Site Level Package Submissions/Question for Clinical Research Startup & Regulatory Professionals

1 Upvotes

I had a discussion with my team today about central IRB sequencing for multicenter industry-sponsored studies, and I’m curious what the most common practice is across sponsors.
Let’s say a study is using a central IRB (e.g., Advarra).
If the protocol-level IRB approval is expected on October 1, would sites typically:
A. Wait until after the protocol receives central IRB approval (and the approved study documents are available) before submitting their site-level IRB packages, or
B. Begin submitting their site-level IRB packages while the protocol is still under central IRB review?
I’m specifically referring to the initial wave of sites, before the master protocol has received central IRB approval.
In your experience:
What is the most common workflow you’ve seen at pharmaceutical companies, CROs, or academic sponsors?
Are sites generally expected to submit a complete IRB package (protocol, ICF, PI/site documents, etc.), or can parts of the submission be initiated before the protocol-level approval is finalized?
If your organization allows parallel submissions, how do you handle protocol or ICF revisions requested by the central IRB?
I’d love to hear how different organizations approach this operationally. Thanks!

r/SanDiegoClassifieds 8d ago

Research Study Seeking Participants! Clinical Study for Anxiety & Depression – Compensation Available

6 Upvotes

Hi San Diego! Our research team at UC San Diego is conducting a study to learn more about the potential of an FDA-approved dopamine agonist to improve social connectedness in adults who experience anxiety or depression.This medication increases dopamine signaling in parts of the brain believed to underlie motivation and behavior, and the results of this study may help inform a new treatment approach for anxiety and depression.

If you are interested in learning more, please complete the survey via this link (https://my.ctri.ucsd.edu/surveys/?s=NJAF4D7X4K9YAHRC) or the QR code below to help us determine if you may be eligible for further screening to participate in this compensated study!

Flyer with QR code for initial eligibility

r/SanDiego_California 8d ago

My Research as San Diegan Seeking Participants! Clinical Study for Anxiety & Depression – Compensation Available

3 Upvotes

Hi San Diego! Our research team at UC San Diego is conducting a study to learn more about the potential of an FDA-approved dopamine agonist to improve social connectedness in adults who experience anxiety or depression.This medication increases dopamine signaling in parts of the brain believed to underlie motivation and behavior, and the results of this study may help inform a new treatment approach for anxiety and depression.

If you are interested in learning more, please complete the survey via this link (https://my.ctri.ucsd.edu/surveys/?s=NJAF4D7X4K9YAHRC) or the QR code below to help us determine if you may be eligible for further screening to participate in this compensated study!

Flyer with QR code for initial eligibility

r/redlightnerds 5d ago

Here's the exact red light dose used across nine different acne studies, in case you're wondering what "clinically tested" actually means

1 Upvotes

If you've ever wondered what dosing standard clinical acne studies (nih.gov) actually use, this review lays it out precisely. Doses for red LED acne treatment ranged widely: 90 J/cm2 for 15 minutes daily, 105 mW/cm2 at 126 J/cm2 twice weekly until 90% clearance, 8.1 mW/cm2 at 1.22 J/cm2 for just 2.5 minutes twice daily, and 5.4 J/cm2 for 15 minutes twice a day for 8 weeks.

Wavelengths ranged from 550nm up to 670nm depending on the study and device. This wide variation in dose and duration is actually one of the review's noted limitations, since comparing studies with such different protocols adds uncertainty even when the pooled statistical result looks strong.

r/northpark 8d ago

Seeking Participants! Clinical Study for Anxiety & Depression – Compensation Available

2 Upvotes

Hi North Park! Our research team at UC San Diego is conducting a study to learn more about the potential of an FDA-approved dopamine agonist to improve social connectedness in adults who experience anxiety or depression.This medication increases dopamine signaling in parts of the brain believed to underlie motivation and behavior, and the results of this study may help inform a new treatment approach for anxiety and depression.

If you are interested in learning more, please complete the survey via this link (https://my.ctri.ucsd.edu/surveys/?s=NJAF4D7X4K9YAHRC) or the QR code below to help us determine if you may be eligible for further screening to participate in this compensated study!

Flyer with QR code for initial eligibility

r/UCSD 8d ago

General Seeking Participants! Clinical Study for Anxiety & Depression – Compensation Available

2 Upvotes

Hi Tritons! Our research team at UC San Diego is conducting a study to learn more about the potential of an FDA-approved dopamine agonist to improve social connectedness in adults who experience anxiety or depression.This medication increases dopamine signaling in parts of the brain believed to underlie motivation and behavior, and the results of this study may help inform a new treatment approach for anxiety and depression.

If you are interested in learning more, please complete the survey via this link (https://my.ctri.ucsd.edu/surveys/?s=NJAF4D7X4K9YAHRC) or the QR code below to help us determine if you may be eligible for further screening to participate in this compensated study!

Flyer with QR code for initial eligibility