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#clinical monitor
inkskinned · 10 months
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so one of the things that's so horrifying about birth control is that you have to, like, navigate this incredibly personal choice about your body and yet also face the epitome of misogyny. like, someone in the comments will say it wasn't that bad for me, and you'll be utterly silenced. like, everyone treats birth control like something that's super dirty. like, you have no fucking information or control over this thing because certain powerful people find it icky.
first it was the oral contraceptives. you went on those young, mostly for reasons unrelated to birth control - even your dermatologist suggested them to control your acne. the list of side effects was longer than your arm, and you just stared at it, horrified.
it made you so mentally ill, but you just heard that this was adulthood. that, yes, there are of course side effects, what did you expect. one day you looked up yasmin makes me depressed because surely this was far too intense, and you discovered that over 12,000 lawsuits had been successfully filed against the brand. it remains commonly prescribed on the open market. you switched brands a few times before oral contraceptives stopped being in any way effective. your doctor just, like, shrugged and said you could try a different brand again.
and the thing is that you're a feminist. you know from your own experience that birth control can be lifesaving, and that even when used for birth control - it is necessary healthcare. you have seen it save so many people from such bad situations, yourself included. it is critical that any person has access to birth control, and you would never suggest that we just get rid of all of it.
you were a little skeeved out by the implant (heard too many bad stories about it) and figured - okay, iud. it was some of the worst pain you've ever fucking experienced, and you did it with a small number of tylenol in your system (3), like you were getting your bikini line waxed instead of something practically sewn into your body.
and what's wild is that because sometimes it isn't a painful insertion process, it is vanishingly rare to find a doctor that will actually numb the area. while your doctor was talking to you about which brand to choose, you were thinking about the other ways you've been injured in your life. you thought about how you had a suspicious mole frozen off - something so small and easy - and how they'd numbed a huge area. you thought about when you broke your wrist and didn't actually notice, because you'd thought it was a sprain.
your understanding of pain is that how the human body responds to injury doesn't always relate to the actual pain tolerance of the person - it's more about how lucky that person is physically. maybe they broke it in a perfect way. maybe they happened to get hurt in a place without a lot of nerve endings. some people can handle a broken femur but crumble under a sore tooth. there's no true way to predict how "much" something actually hurts.
in no other situation would it be appropriate for doctors to ignore pain. just because someone can break their wrist and not feel it doesn't mean no one should receive pain meds for a broken wrist. it just means that particular person was lucky about it. it should not define treatment.
in the comments of videos about IUDs, literally thousands of people report agony. blinding, nauseating, soul-crushing agony. they say things like i had 2 kids and this was the worst thing i ever experienced or i literally have a tattoo on my ribs and it felt like a tickle. this thing almost killed me or would rather run into traffic than ever feel that again.
so it's either true that every single person who reports severe pain is exaggerating. or it's true that it's far more likely you will experience pain, rather than "just a pinch." and yet - there's nothing fucking been done about it. it kind of feels like a shrug is layered on top of everything - since technically it's elective, isn't it kind of your fault for agreeing to select it? stop being fearmongering. stop being defensive.
you fucking needed yours. you are almost weirdly protective of it. yours was so important for your physical and mental health. it helped you off hormonal birth control and even started helping some of your symptoms. it still fucking hurt for no fucking reason.
once while recovering from surgery, they offered you like 15 days of vicodin. you only took 2 of them. you've been offered oxy for tonsillitis. you turned down opioids while recovering from your wisdom tooth extraction. everything else has the option. you fucking drove yourself home after it, shocked and quietly weeping, feeling like something very bad had just happened. the nurse that held your hand during the experience looked down at you, tears in her eyes, and said - i know. this is cruelty in action.
and it's fucked up because the conversation is never just "hey, so the way we are doing this is fucking barbaric and doctors should be required to offer serious pain meds" - it's usually something around the lines of "well, it didn't kill you, did it?"
you just found out that removing that little bitch will hurt just as bad. a little pinch like how oral contraceptives have "some" serious symptoms. like your life and pain are expendable or not really important. like maybe we are all hysterical about it?
hysteria comes from the latin word for uterus, which is great!
you stand here at a crossroads. like - this thing is so important. did they really have to make it so fucking dangerous. and why is it that if you make a complaint, you're told - i didn't even want you to have this in the first place. we're told be careful what you wish for. we're told that it's our fault for wanting something so illict; we could simply choose not to need medication. that maybe if we don't like the scraps, we should get ready to starve.
we have been saying for so long - "i'm not asking you to remove the option, i'm asking you to reconsider the risk." this entire time we hear: well, this is what you wanted, isn't it?
#where's the word woman in this u might wonder if u suck#good news i am nonbinary and have a uterus so that is something that can happen#im also gender fluid tho which means im immune to certain psychic damage bc if u call me a woman i'll be like <3 okay <3#writeblr#the tightrope of ''ppl need access to this''#and like also#''what the fuck is going on over there'' is like. so difficult as an activist#i was <3 punctured <3 during mine#and almost bled out on the table :) they didn't have anyone standing by bc it's ''just a little insertion''#so i started crashing and i vaguely remember apologizing for the fuss as i heard my heart rate monitor start going <3 tachycardic <3#she wasn't even a bad doctor tbh#ps btw the reason i even HAD a heart monitor is that i have a genuine heart condition and they knew GOING IN that there was a chance#i'd crash on the table#like my heart just likes to do fun little tricks and <3 stop working <3 (i do not want to discuss the specifics ty i am okay im ontop of it#and they were like 'oh u will be fine' and then she did do a puncture thru my uterus . pop!#and im sitting there dizzy and feeling my heartrate start to drop bc it feels almost. beautiful. like. the whole ground just#woosh! out from under you. and shit is like grey's anatomy. i'm looking up at her grey eyes#she's old she wears this nice shawl she's like got Cool Lesbian vibes and people are sprinting into the room#from other parts of the clinic unrelated to me. while the monitor is like a little aria singing#and shes like hey youre okay stay awake stay with me something went wrong we have to keep trying#and i remember thinking - i was trying to think of nice things. i have so many beautiful places that now overlap#with this terrible memory#i became dimly aware that there was too much on her wrists and hands. like#that was too many liters#and then when they had finished all this. i packed up and drove myself home#i have had (bad thing) happen to me. and the same feeling happened after#that numb almost lamblike bleating. you cry without noise. like. ur body is so shocked and ur mind so empty#you just stare at the road and everything everything is happening behind glass and static and you are standing so far away from it#while you hold ur hands at 10 and 2. and something in ur brain is SCREAMING at you - IT WAS BAD AND IT SHOULDNT HAVE HAPPENED#and ur just watching the alarms in your body going off and youre thinking. a little pinch! ha. i think i just lost something important.
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ccrpsorg · 1 year
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Clinical Research Monitoring: A Guide to Clinical Monitoring
Clinical research monitoring is a vital part of clinical trials and it involves various activities to ensure the safety and accuracy of the data collected. It is important that the clinical trial is conducted in a way that meets regulatory standards, protects human studies participants, and minimizes potential risks to their health and well-being. Clinical trial monitoring can include activities such as auditing study sites, evaluating data for accuracy and completeness, review of protocols and amendments, reviewing case report forms (CRFs), identifying any deviations from the standard operating procedures (SOPs) or protocols, managing corrective action plans (CAPs), following up on safety reports, tracking progress against enrollment goals and much more. Apart from evaluating data quality, clinical research monitoring also ensures compliance with all regulatory standards like GCP (Good Clinical Practices) ICH (International Conference on Harmonization), FDA regulations and local laws. In addition to this ongoing monitoring throughout a study's duration, there may be audits conducted by sponsors or regulatory authorities at any time during or after completion of a clinical trial. All these efforts are dedicated towards ensuring that the results obtained from a clinical trial are accurate, reliable and applicable for use in making medical decisions.
Steps to Clinical Monitoring
1. Establish an Effective Monitoring Plan: Ensure that the plan is comprehensive and contains all applicable elements, such as the types of monitoring activities to be conducted, frequency of monitoring visits, data collection methods, and specific criteria for acceptable performance.
2. Develop Appropriate Documentation: Design protocol-specific monitoring tools and forms to document information from site visits including source documents, data collection instruments, case report forms (CRF). In addition, develop a Monitoring Log or Tracking System which will enable better accountability for study activities.
3. Execute Monitors’ Visits: Depending on the complexity of the trial and regulatory requirements, conduct pre-study qualification visits (PSQV), pre-initiation visits (PIV), initiation visits (IVs), periodic monitoring visits (PMV) and close out visits (COV). During each visit, ensure that good clinical practice is followed at all times by reviewing source documents and data collection instruments. Review patient enrollment logs to ensure accuracy and record any discrepancies in the visit report.
4. Report Findings: Generate detailed yet concise reports per each monitor's visit with clear recommendations for corrective actions if required; provide professional feedback to investigators regarding their performance; identify any areas of noncompliance with protocol requirements or applicable regulations; recommend training or educational sessions when appropriate; track all follow up activities related to corrective actions taken in response to findings from monitors' visits; ensure that essential documentation is complete before closing out a particular study site.
5. Quality Assurance: Validate accuracy of tracking systems used by monitors during their visits; assess risk associated with various deficiencies identified during monitoring process; carry out periodic internal audits/assessments to ensure compliance with established SOPs/guidelines related to clinical research monitoring activities; take preventive measures based on audit/assessment results in order to strengthen internal quality system processes.
Types of Clinical Trial Monitoring
1. Types of Clinical Research Monitoring: Clinical research monitoring is the process to assess the quality and integrity of clinical trial data and ensure compliance with applicable regulatory requirements. It can be done through three primary methods: onsite monitoring, centralized or remote monitoring, and risk-based approaches.
2. Onsite Monitoring: Onsite monitoring is considered the "gold standard" for clinical research monitoring, as it requires the presence of a monitor at a study site during the entire duration of a trial. The monitor will typically review source documentation such as patient records, lab results, and investigational product dispensing logs to assess accuracy and conformance with study protocols and good clinical practices (GCP). The monitor also interviews staff members responsible for conducting the trial to verify that procedures are being followed properly.
3. Centralized or Remote Monitoring in Clinical Trials: Centralized or remote monitoring enables sponsors to conduct clinical research monitoring without needing to send someone onsite to each study location. This is accomplished by using technology such as web portals, video conferencing, and virtual meetings that allow monitors to remotely review data from various sites simultaneously and quickly flag any issues that arise. Additionally, centralized/remote monitoring allows sponsors to be more proactive in identifying potential risks associated with a trial prior to sending monitors onsite for an assessment.
4. Risk-Based Approaches: Risk-based approaches use data analytics tools such as descriptive statistics and predictive algorithms to identify potential trends or outliers in clinical trial data that may represent heightened risk of noncompliance with GCPs or other regulations. By leveraging technology, these approaches can help sponsors identify issues earlier in the course of a trial so they can take corrective action before something goes wrong.
5. Benefits of Clinical Research Monitoring: Utilizing effective clinical research monitoring strategies helps ensure that trials are conducted ethically, safely, correctly according to protocol standards, within timelines agreed upon with regulatory authorities, and within budget constraints set out by sponsors/CROs/investigators/other stakeholders involved in a study’s execution.. Clinical research monitors act as an independent third party who are able to provide objective insight into how studies are being conducted across multiple sites which helps minimize errors due to bias from investigators or other personnel who may have vested interests in outcomes associated with their studies.. In addition, effective clinical research monitoring helps ensure patient safety by providing oversight about how drugs or medical devices used in trials are administered as well as ensuring patient confidentiality is maintained throughout the course of a study.. Lastly, robust clinical research monitoring protocols help reduce costs associated with delays caused by errors made during trials which can add up significantly over time if not avoided through proper oversight methods both pre-study start up until closeout occurs after all enrolled patients have completed their participation in a given trial
Clinical Research Monitoring Guide
1. Understand the Basics of Clinical Research Monitoring: Clinical research monitoring is a key part of the clinical research process, ensuring the safety and accuracy of results. It involves periodically assessing study sites to confirm that data is being collected properly, according to ethical and legal requirements, as per Good Clinical Practice (GCP) guidelines.
2. Know What Types of Studies are Monitored: Clinical research monitoring can be used for a variety of studies, including clinical trials, observational studies, epidemiologic studies, and public health surveys. It is important to know what type of study you are monitoring in order to ensure that the appropriate procedures are followed.
3. Understand How to Monitor a Study Site: The primary goal of clinical research monitoring is to confirm that the protocol and informed consent form have been followed properly at each site. This requires a thorough review of all relevant documents such as case report forms (CRFs), source documentation (e.g., physician notes), internal audit reports (audit trails), and external quality assurance reports. Additionally, it involves evaluating compliance with GCP guidelines during study visits or remote reviews, as well as conducting interviews with staff members to assess how they are handling data collection and reporting processes.
4. Become Familiar With Regulatory Requirements: In addition to GCP guidelines, there may be applicable regulations from local governments or other institutions that must be adhered to when conducting clinical research monitoring activities. Understanding these regulations is essential for ensuring compliance with applicable laws and regulations related to clinical research activities.
5. Develop an Effective Monitoring Plan: An effective monitoring plan should include a detailed timeline for visiting sites, information about any specific areas where focused attention is required (e.g., enrolling/randomizing patients or managing adverse events), and plans for auditing/reviewing data generated by the study site(s). Additionally, it should incorporate measures for controlling risk associated with data collection processes so that issues can be identified early on in the study process before they become problematic later on down the line.
Clinical Research Monitor Job
The job of a Clinical Research Monitor is to ensure that clinical trials are conducted ethically, safely and in compliance with established standards. The primary responsibility of the monitor is to protect the rights, safety and well-being of the human subjects enrolled in the trial. Duties typically include developing protocols for clinical studies; coordinating study start up activities; conducting site visits; monitoring data for timeliness, accuracy and completeness; auditing files for regulatory compliance; managing investigator queries/issues; preparing visit reports; reviewing update protocols related to study operations; resolving issues raised through audit reports or other sources; providing technical guidance to sites regarding protocol implementation or study conduct; and escalating complex issues or potential risks as needed.
Clinical Research Monitor Salary
Salaries for this position tend to vary depending on education level, experience and geographical location but can range from $60,000 per year for entry level positions up to around $90,000 per year for more experienced professionals. In addition to salary many employers also offer benefits such as paid vacation days, health insurance plans and retirement packages.
Resources for Clinical Research Monitoring
1. National Institutes of Health (NIH): Clinical Research Monitoring
This link provides information on NIH's guidelines for monitoring clinical research, which include topics such as the roles and responsibilities of the investigator, data safety monitoring boards, and protocols for reporting unanticipated problems and adverse events.
2. National Institutes of Health (NIH): Guide to Clinical Research Monitoring
This comprehensive guide walks readers through all aspects of clinical research monitoring, including topics such as study design, randomization strategies, regulatory compliance requirements, data management, monitoring plans and reports, quality improvement initiatives, and safety assessments.
3. US Food and Drug Administration (FDA): Guidelines for Clinical Trials Monitoring
This resource from the FDA outlines the importance of effective monitoring in clinical trials and provides an overview of the different roles within a clinical trial as well as details about essential elements for implementation of an effective monitoring strategy such as risk assessments and adverse event tracking.
4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
ICH has developed standards that provide a set of harmonized technical requirements for clinical trials conducted across countries in the European Union (EU), Japan, and US with an emphasis on quality assurance and safety monitoring during trials.
5. Association of Clinical Research Professionals (ACRP)
ACRP's guidelines provide best practice recommendations for conducting clinical research studies in accordance with applicable regulations and standards to ensure patient safety monitoring during studies as well as data integrity throughout the process from start to finish.
6. Pharmaceutical Research & Manufacturers of America (PhRMA)
The PhRMA guidelines provide an overview of expectations around clinical research activities with respect to ethics, data integrity, safety reporting, resource allocation and more. It defines roles and responsibilities of all those involved in overseeing a clinical trial such as a Clinical Research Monitor or CRA who has primary responsibility for ensuring that the protocol is implemented correctly throughout a study’s duration
Clinical Research Monitoring Review
1. What is the main purpose of clinical research monitoring?
A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards
B) To ensure that data collected during a research study is accurate and reliable
C) To evaluate the safety of participants enrolled in a research trial
D) To oversee the financial management of a research project
Answer: A) To ensure that a research study is conducted in accordance with applicable regulations and ethical standards. Clinical Research Monitors are responsible for ensuring compliance with Good Clinical Practice guidelines, protecting participant privacy, verifying data accuracy, and evaluating protocol deviations. In addition, they may also be involved in reviewing participant eligibility requirements, conducting site assessments, providing training to investigators and staff on proper study procedures, as well as monitoring progress towards completion of all requirements of the study.
2. What type of individuals typically serve as clinical research monitors?
A) Physicians
B) Nurses
C) Regulatory specialists
D) All of the above
Answer: D) All of the above. Clinical Research Monitors can come from various backgrounds such as medical doctors (MDs), nurses (RNs), pharmacists (RPhs), regulatory specialists (e.g., Regulatory Affairs Professionals or Paralegals), or biostatisticians/data analysts who have experience in clinical trials and understand local regulations related to human subject protection. Each monitor has specific job duties depending on their education and experience, such as assessing compliance with regulatory guidance or analyzing data sets for accuracy, completeness, integrity, or validity.
3. What kind of activities do clinical research monitors need to perform?
A) Protocol reviews or verifications
B) Ensuring appropriate documentation completion
C) Site visits to observe investigator conduct
D )All of the above
Answer: D )All of the above. Clinical Research Monitors need to perform several activities including protocol reviews or verifications; ensuring appropriate documentation completion; site visits to observe investigator conduct; liaising between sponsors and sites; assisting with resolving issues associated with adverse events; reviewing case report forms for completeness, accuracy, consistency and correctness; evaluating subject safety throughout enrollment process;and writing reports detailing their findings at each visit.
4. What is one benefit gained from having an effective Clinical Research Monitor on-site? A) Reduced risk for legal liability stemming from negligence
B) Improved protocol adherence by investigators
C) Increased patient engagement during trial period
D )All of the above
Answer: D) All of the above . An effective Clinical Research Monitor encompasses several benefits such as reduced risk for legal liability stemming from negligence due to thorough oversight and accurate record keeping; improved protocol adherence by investigators through continued communication between sponsor representatives and researchers on-site regarding best practices; increased patient engagement during trial period due to more detailed explanations about potential risks/benefits offered by having monitor on-site ; and improved efficiency when dealing with complex protocols that require multiple levelsof oversight due to familiarity with protocol specifics which decreases time spent troubleshooting errors or unclear instructions..
5. How often should Clinical Research Monitors visit a particular site?
A) Weekly B) Biweekly C) Monthly D) Quarterly
Answer: C) Monthly . It is recommended that Clinical Research Monitors visit sites at least once per month in order to maintain active surveillance over ongoing studies at each location while also providing timely feedback regarding any issues discovered while on-site visits are taking place within a shorter timeframe if needed based upon changes made midstream or other unanticipated circumstances which might require immediate attention by sponsor personnel.
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bbreaddog · 5 months
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#personal#finally got an appt with my psych this morn and FINALLY got her to write a support letter for my disability support pension claim#GOD#only took like 3 emails in the past week and a friend to call them up on my behalf to pester them about it#just submitted my claim#I was told I’d be exempt from my mutual obligations to meet my benchmark work hours while the claim processes#so hopefully means I can catch a whole break instead of the half I’ve been given the past month#I hope this works#I really hope this works#I don’t wanna have to rely financially on my parents when I already rely on them so much for everything else#also health update: currently wearing a 28-day heart monitor and it is so itchyyyyy#I have follow up appts with the cardiology clinic for other tests in the next month#seeing rheumatologist in march#yet to book with audiologist bc the clinic I’d contacted said they don’t offer the services I’m after and referred me to their other clinic#which is on the other side of the city#and I’m trying to find a different clinic that’s closer and offers the services I need#god but for now#I think I’m just gonna fuckin#not think about health and appts for a while#at least for the week#I’ve been invited to work dinner tomorrow and it’s gonna be my first time seeing everyone in like 1.5 months#they’re all around or younger than my age so like#I know they’re not gonna comment negatively about my appearance#but god do I have such anxiety about it#I’m so used to brown parents commenting on weight loss and acne and complexion whenever I’m ill#but that’s a different generation#these colleagues are alright#I just hope I have enough energy to last the night
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toonfinatic · 1 day
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Debating on maybe getting some food at the marketplace tomorrow because it's Vappu
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lesbiten · 2 months
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theres a cat whose been hospitalized at work for the past week, and i met him for the first time yesterday. came in, immediately went "...is he dead?"
the answer was no, he was just mildly sedated. however, today the answer has changed to "maybe". literally all of his shit is fucked
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finalgoob · 2 years
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so i'm in my anesthesia rotation rn right. i was wondering why the trope of being sedated for tooth extraction and then forgetting thing exists in like . shows and fics n stuff ? when all my life all dental stuff have been just local anesthesia ... WELL turns out its cause i live in a 3rd world country
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annoyingalchemist · 6 months
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Man whenever somebody mentions medical trauma I instinctively go "oh well I dunno much about that most of my experiences have been pretty positive" and then remember the two? weeks I was held hostage in inpatient and the subsequent six months of drug addled, painful recovery, which has left me with a permanent fear of things under my skin or restricting my movement, the latter of which is so severe that I apparently wake up in a panic if my boyfriend accidentally shifts his leg on top of mine.
Your brain is so good at lying to you y'all. It's fucked up.
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singlethread · 8 months
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wink-wonk · 1 year
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I hate meetings I hate meetings I hate meetings I hate meetings I hate meetings I hate meetings I hate meetings!!!
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lvnce-mcclain · 1 year
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// animal clinic //
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miradorhealth · 18 days
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pathologylab · 2 months
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#G2M is thrilled to introduce you to our #RapiCycler 96 Real-Time PCR #System, which is designed for high-end laboratory needs and experimental #analysis characterized by #Polymerase Chain Reaction (PCR) for the purpose of #DNA/RNA detection, and can be widely used in a variety of areas including Clinical #Diagnosis, Epidemiological Monitoring, Food Safety, Forensics & Scientific Research, etc. With the 4 or 6 fluorescence channels, it can process up-to 96 #samples in one run.
Visit our website for more information https://www.genes2me.com/front_asset/products/detail-pdf/RapiCycler%2096.pdf
For more details, Call us at +91-8800821778 or drop us an email at [email protected]
#genes2me #pcr #rtpcr #monitoring #research #ivd #clinicalresearch #devices #rna #detection #madeinindia #india
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danieljosephusa · 6 months
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vimeo
Coronary Angioplasty is a minimally invasive procedure that restores blood flow to the heart by opening blocked arteries. North Queensland Cardiac Clinic (NQCC) in Pimlico, Australia, is a reliable centre for this procedure, offering expert technicians and state-of-the-art equipment. This technique treats coronary artery disease (CAD), which occurs when plaques obstruct blood flow in the coronary arteries. The procedure involves:
● Inserting a catheter with a balloon tip into the narrowed artery.
● Inflating it to widen the passage.
● Often placing a stent for support. This procedure is significant for its life-saving potential and symptom improvement. Afterwards, patients are advised to adopt heart-healthy lifestyle changes for long-term well-being. Contact North Queensland Cardiac Clinic in Pimlico for top-quality Coronary Angioplasty Test services.
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shareyourideas · 7 months
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What Resources You Need for Your Small Clinic
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buyanabolic · 7 months
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What are The Uses, Dosage and Clinical Monitoring of Anastrozole 1mg?
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Breast cancer patients use oral tablets containing anastrozole under the brand name Arimidex. After menopause, these are given to women. A natural hormone called oestrogen causes some breast tumours to grow more rapidly than usual. Women are then given Anastrozole 1mg to reverse or inhibit the growth of breast cancers, therefore lowering the body's oestrogen levels. Anastrozole should not be administered to women who have not reached menopause. If you happen to be pregnant or plan to become pregnant, avoid taking this medication immediately away. 
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