Poorly Controlled Type 1 Diabetes in children linked to MASLD irrespective of overweight: Study

Recent research study has highlighted the intricate connection between metabolic dysfunction associated with steatotic liver disease (MASLD) and diabetes, particularly type 2 diabetes (T2D). MASLD, characterized by liver steatosis, presents a significant health concern, particularly in individuals with diabetes. Effective management of T1D is essential to mitigate the risk of liver injury in pediatric patients.

This study aimed to explore the relationship between poorly controlled T1D and liver injury in children and adolescents. The study was published in the Journal Of Pediatric Gastroenterology and Nutrition. The study was conducted by Koutny F. and colleagues.

The prevalence of diabetes, including T1D, among children and adolescents is a growing public health concern. While MASLD is well-established in individuals with T2D, its association with T1D requires further investigation. Elevated alanine aminotransferase (ALT) levels serve as a proxy for MASLD, highlighting liver injury in diabetic patients. Effective glycemic control is crucial to prevent complications such as MASLD in pediatric patients with T1D.

The study analyzed clinical and laboratory data from pediatric patients (aged 2-17 years) with T1D across multiple centers in Germany, Austria, Switzerland, and Luxembourg. Researchers examined the association between poorly controlled T1D, indicated by hemoglobin A1C (HbA1C) levels, and elevated ALT levels, a marker of MASLD.

The key findings of the study were as follows:

  • Among 32,325 participants, 14.4% presented with elevated ALT levels at baseline.

  • Factors such as overweight status (BMI ≥ 90th percentile) and poorly controlled T1D (HbA1C ≥ 11%) were associated with higher odds of elevated ALT levels, indicating liver injury.

  • Long-term follow-up data revealed that inadequately controlled T1D increased the risk of elevated ALT levels over a period of up to 5.5 years.

  • Children with HbA1C ≥ 11% and overweight status had the highest risk of liver injury, emphasizing the importance of glycemic control and weight management.

The study underscores the critical role of effective diabetes management in pediatric patients with T1D to prevent liver injury associated with MASLD. Regular monitoring of liver enzymes is essential for early detection and intervention. These findings emphasize the complex interplay between glycemic control, weight status, and liver health in children and adolescents with T1D, highlighting the need for comprehensive care strategies to optimize patient outcomes.

Reference:

Koutny F, Wiemann D, Eckert A, et al. Poorly controlled pediatric type 1 diabetes mellitus is a risk factor for metabolic dysfunction associated steatotic liver disease (MASLD): An observational study. Journal of Pediatric Gastroenterology and Nutrition. https://doi.org/10.1002/jpn3.12194

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Gestational Hypertension Linked to Cognitive Decline in new research

Hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, and eclampsia, are known to have significant implications for maternal and fetal health during pregnancy. However, their potential long-term impact on cognitive function later in life remains unclear, particularly among Hispanic/Latina individuals in the United States.

A recent study conducted as part of the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) aimed to address this gap in knowledge. The study was published in the journal Obstetrics and Gynecology. The study was conducted by Elfassy T. and colleagues.

Hypertensive disorders of pregnancy are prevalent and can have serious consequences for both maternal and infant health. Understanding their association with cognitive decline later in life is essential for identifying potential long-term health risks among affected individuals, particularly in diverse populations such as Hispanic/Latina communities in the United States.

The study analyzed data from the HCHS/SOL, a population-based study of Hispanic/Latino individuals aged 18–74 years from four U.S. communities. Participants included parous individuals aged 45 years or older who underwent neurocognitive assessments at two study visits: visit 1 (2008–2011) and visit 2 (2015–2018). Hypertensive disorders of pregnancy were retrospectively assessed, and cognitive functioning was measured using standardized tests. Linear regression models were used to assess the association between hypertensive disorders of pregnancy and cognitive decline, adjusting for various factors.

The key findings of the study were as follows:

  • The analysis included 3,554 individuals with a mean age of 56.2 years, among whom 13.4% reported at least one hypertensive disorder of pregnancy.

  • Gestational hypertension was associated with a 0.17-standard deviation (SD) decline in Digit Symbol Substitution scores (95% CI, −0.31 to −0.04) after an average of 7 years of follow-up.

  • However, neither preeclampsia nor eclampsia was associated with neurocognitive differences.

  • Individuals with hypertensive disorders of pregnancy had higher mean systolic blood pressure, fasting glucose, and body mass index compared to those without.

The study concludes that among the U.S. Hispanic/Latina individuals, gestational hypertension alone is associated with decreased processing speed and executive functioning later in life. However, there was no significant association observed between preeclampsia or eclampsia and cognitive decline. These findings highlight the importance of identifying and managing gestational hypertension to potentially mitigate the risk of cognitive impairment in later years. Further research is needed to elucidate the underlying mechanisms and develop targeted interventions for at-risk individuals.

Reference:

Elfassy, T., Kulandavelu, S., Dodds, L., Mesa, R. A., Rundek, T., Sharashidze, V., Paidas, M., Daviglus, M. L., Kominiarek, M. A., Stickel, A. M., Perreira, K. M., Kobayashi, M. A., Garcia, T. P., Isasi, C. R., Lipton, R. B., & González, H. M. (2024). Association between hypertensive disorders of pregnancy and interval neurocognitive decline: An analysis of the Hispanic Community Health Study/study of Latinos. Obstetrics and Gynecology, 10.1097/AOG.0000000000005571. https://doi.org/10.1097/aog.0000000000005571

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CT Fractional Flow Reserve imaging may predict which CAD patients would benefit from PCI: Study

A recent retrospective observational study has unveiled a transformative approach to managing coronary artery disease (CAD) utilizing CT fractional flow reserve (CT-FFR) analysis. The study, conducted without heart rate control, showcases the potential of this technique to significantly reduce the need for invasive procedures in patients with significant stenosis, revolutionizing the landscape of cardiac care. The study results were published in the journal Radiology: Cardiothoracic Imaging. 

Conducting CT fractional flow reserve (CT-FFR) analysis on dual-source CT scans, administered without the need for heart rate regulation, among patients presenting significant stenosis, demonstrated a notable reduction in the incidence of invasive procedures such as coronary angiography and percutaneous coronary intervention (PCI), all while maintaining safety standards. Hence, researchers conducted a retrospective observational study to analyze the clinical outcomes of CT fractional flow reserve (CT-FFR) analysis using dual-source coronary CT angiography (CTA) scans performed without heart rate control. 
Also Read: CT Scans may help distinguish Between Transudates and Exudates in Pleural Effusion: Study
Spanning from August 2020 to August 2021, the study included all patients undergoing clinically indicated coronary CT angiography (CTA). Notably, scans were performed in the late systolic to early diastolic period without heart rate control and analyzed based on the interpreting physician’s discretion. Through meticulous chart review, researchers assessed demographic data, coronary CTA features, and clinical outcomes at 3 months post-procedure, including rates of invasive coronary angiography (ICA), percutaneous coronary intervention (PCI), myocardial infarction, and all-cause death. Out of 3098 patients undergoing coronary CTA, a subset of 292 individuals (9.7%) was referred for CT-FFR analysis.
Findings:
  • Throughout the study duration, 3098 patients underwent coronary computed tomography angiography (CTA), with 113 individuals having undergone coronary bypass grafting being excluded from the analysis.
  • Among the remaining 2985 patients, 292 (9.7%) were referred for CT fractional flow reserve (CT-FFR) analysis.
  • A small proportion, comprising two studies (0.7%), was disqualified from CT-FFR analysis, while six (2.1%) analyses did not assess the target lesion.
  • Notably, 160 patients (56.3%) exhibited CT-FFR values exceeding 0.80.
  • Among patients diagnosed with significant stenosis via coronary CTA, those who underwent CT-FFR analysis demonstrated markedly reduced rates of invasive coronary angiography (ICA) (74.5% vs 25.5%, P = .04) and percutaneous coronary intervention (PCI) (78.9% vs 21.1%, P = .05).
Also Read: Low-Dose CT Scans Show Promise in Evaluating Kidney Volume in Polycystic Kidney Disease
The study’s findings challenge traditional approaches to CAD management, particularly in patients with significant stenosis and an average heart rate of 65 beats per minute, where heart rate control may not be deemed necessary. By leveraging dual-source coronary CTA acquisition, CT-FFR analysis emerges as a game-changing tool, guiding clinicians towards more precise and tailored treatment strategies. By harnessing the power of CT-FFR analysis, clinicians can now navigate the complexities of CAD with greater precision and confidence, sparing patients unnecessary invasive procedures while ensuring timely and effective treatment. As further research and validation efforts unfold, the widespread adoption of CT-FFR analysis promises to revolutionize the standard of care for CAD patients worldwide. 
Further reading: Randhawa, Mangun K et al. “Selective Use of CT Fractional Flow at a Large Academic Medical Center: Insights from Clinical Implementation after 1 Year of Practice.” Radiology. Cardiothoracic imaging vol. 6,2 (2024): e230073. doi:10.1148/ryct.230073

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AI-assisted breast-cancer screening may reduce unnecessary testing, finds study

The researchers developed an algorithm that identified normal mammograms with very high sensitivity.

They then ran a simulation on patient data to see what would have happened if all of the very low-risk mammograms had been taken off radiologists’ plates, freeing the doctors to concentrate on the more questionable scans.

The simulation revealed that fewer people would have been called back for additional testing but that the same number of cancer cases would have been detected.

“False positives are when you call a patient back for additional testing, and it turns out to be benign,” explained senior author Richard L. Wahl, MD, a professor of radiology at Washington University’s Mallinckrodt Institute of Radiology (MIR) and a professor of radiation oncology.

“That causes a lot of unnecessary anxiety for patients and consumes medical resources. This simulation study showed that very low-risk mammograms can be reliably identified by AI to reduce false positives and improve workflows.”

The study is published April 10 in the journal Radiology: Artificial Intelligence.

Wahl previously collaborated with Whiterabbit.ai on an algorithm to help radiologists judge breast density on mammograms to identify people who could benefit from additional or alternative screening.

That algorithm received clearance from the Food and Drug Administration (FDA) in 2020 and is now marketed by Whiterabbit.ai as WRDensity.

In this study, Wahl and colleagues at Whiterabbit.ai worked together to develop a way to rule out cancer using AI to evaluate mammograms.

They trained the AI model on 123,248 2D digital mammograms (containing 6,161 showing cancer) that were largely collected and read by Washington University radiologists.

Then, they validated and tested the AI model on three independent sets of mammograms, two from institutions in the U.S. and one in the United Kingdom.

First, the researchers figured out what the doctors did: how many patients were called back for secondary screening and biopsies; the results of those tests; and the final determination in each case.

Then, they applied AI to the datasets to see what would have been different if AI had been used to remove negative mammograms in the initial assessments and physicians had followed standard diagnostic procedures to evaluate the rest.

For example, consider the largest dataset, which contained 11,592 mammograms.

When scaled to 10,000 mammograms (to make the math simpler for the purposes of the simulation), AI identified 34.9% as negative.

If those 3,485 negative mammograms had been removed from the workload, radiologists would have made 897 callbacks for diagnostic exams, a reduction of 23.7% from the 1,159 they made in reality.

At the next step, 190 people would have been called in a second time for biopsies, a reduction of 6.9% from the 200 in reality.

At the end of the process, both the AI rule-out and real-world standard-of-care approaches identified the same 55 cancers.

In other words, this study of AI suggests that out of 10,000 people who underwent initial mammograms, 262 could have avoided diagnostic exams, and 10 could have avoided biopsies, without any cancer cases being missed.

“At the end of the day, we believe in a world where the doctor is the superhero who finds cancer and helps patients navigate their journey ahead,” said co-author Jason Su, co-founder and chief technology officer at Whiterabbit.ai. “The way AI systems can help is by being in a supporting role. By accurately assessing the negatives, it can help remove the hay from the haystack so doctors can find the needle more easily. This study demonstrates that AI can potentially be highly accurate in identifying negative exams. More importantly, the results showed that automating the detection of negatives may also lead to a tremendous benefit in the reduction of false positives without changing the cancer detection rate.”

Reference: Stefano Pedemonte, Trevor Tsue, Brent Mombourquette, Yen Nhi Truong Vu, Thomas Matthews, Rodrigo Morales Hoil, Meet Shah, Nikita Ghare, Naomi Zingman-Daniels, Susan Holley, Catherine M. Appleton, Jason Su, Richard L. Wahl. A Semiautonomous Deep Learning System to Reduce False-Positive Findings in Screening Mammography. Radiology: Artificial Intelligence, 2024; DOI: 10.1148/ryai.230033

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Endoscopic Assisted Percutaneous Fixation of Anterior Inferior Iliac Spine Avulsion Fracture: Surgical Technique

Avulsion fractures of the anterior inferior iliac spine rarely occur in adolescent athletes during rectus femoris contractions or eccentric muscle lengthening while the growth plate is still open. Currently, there are no official guidelines in the literature on the treatment indications of this type of fracture or the type of surgical technique to be used. Nowadays, young and athletic patients desire a quick return to their previous activities, which makes surgical treatment a reasonable choice. Open reduction and internal fixation with an anterior approach are usually recommended when the avulsion fragment has more than 1.5–2 cm displacement on plain radiographs. However, ORIF is associated with a higher risk of heterotopic ossifications and increases the risk of damage to the Lateral femoral cutaneous nerve (LFCN).

Alessandro Aprato et al designed an endoscopic technique to reduce these complications. The technical note describes a procedure of percutaneous fixation to AIIS through 3 endoscopic portals that could potentially minimize complications associated with an open surgical dissection, allowing anatomic reduction under direct visualization. It has been published in ‘Indian Journal of Orthopaedics.’

Technical note:

On a radiolucent bed, the limb to be operated on is left free so that the hip can be flexed during surgery if necessary. Through intraoperative x-rays, the AIIS is identified so the three endoscopic portals can be located:

(1)Lateral Portal (LP): 2 cm lateral to the AIIS;

(2)Direct Portal (DP): directly on the AIIS;

(3)Inferior Portal (IP): 1 cm inferior to the AIIS.

Starting from the LP and DP portals, nitinol wires are introduced, and then the 30° optic and the radiofrequency are placed. The water pump is activated until a pressure of 40 mmHg is reached. Approaching the LP it is crucial to avoid being too lateral to the AIIS as there is a risk of entering the territory of the LFCN; in fact, it emerges under the inguinal ligament, just medial to the ASIS and descends along the surface of the sartorius muscle, in case of injury there is a risk of causing paresthetic meralgia.

On the medial side, femoral vascular-nervous structures are at risk, so care must be taken to locate the DP and IP portals. By endoscopic vision, the fracture is identified; through the use of a shaver and radiofrequency, an accurate debridement of the fracture’s interface is performed, allowing it to be mobilized. Through the IP, a switching stick or a shaver is inserted, and it can be used for the reduction maneuver, with the aim of reducing the fragment as anatomically as possible. If there is difficulty in retracting the avulsed fragment, flexion of the hip can be helpful, detending the rectus femoris muscle. Once anatomical reduction is achieved, a 2 mm k-wire is inserted perpendicular to the fracture by the same portal, and an intraoperative x-ray check is necessary to confirm adequate temporary reduction. Finally, the definitive fixation can be performed with a partially threaded cannulated inter fragmentary screw 4.5 mm in diameter inserted by the IP.

Limitation of the proposed technique is the cost associated with the arthroscopic instrumentation, a possible extension of surgical time and the demand for excellent arthroscopic skills.

Further reading:

Endoscopic Assisted Percutaneous Fixation of Anterior Inferior Iliac Spine Avulsion Fracture, Surgical Technique

Alessandro Aprato et al

Indian Journal of Orthopaedics (2024) 58:433–438

https://doi.org/10.1007/s43465-024-01107-5

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Non-invasive ventilation and early mobilization improves VAP prevention: Study

A recent study published in the Journal of Hospital Infection found selective decontamination of the digestive tract (SDD) and the non-invasive ventilation (NIV) use to protect against Ventilator-Associated Pneumonia (VAP) which is a significant threat to critically ill patients on mechanical ventilation.

The comprehensive analysis reviewed a total of 34 interventions across 31 studies and identified the key strategies to reduce the incidence of VAP in intensive care practices. VAP poses a formidable challenge in critical care, with its incidence directly impacting the patient outcomes and healthcare costs. The meticulous review of randomized and quasi-randomized controlled trials revealed that 19 of the total interventions studied markedly reduced VAP incidents. This study highlighted the effectiveness of selective decontamination of the digestive tract and the use of non-invasive ventilation in weaning patients from mechanical ventilation as the most promising preventive measures.

SDD involved the application of topical antibiotics in the oropharynx and gastrointestinal tract and was backed by highly suggestive (Class II) evidence showing a risk ratio (RR) of 0.439. This indicates a significant reduction in VAP rates among the patients receiving SDD when compared to the individuals who did not. Also, NIV showed a compelling reduction in VAP incidence, with its evidence strength upgraded to highly suggestive (Class II) based on a risk ratio of 0.32 that highlights its efficacy in safely reducing the duration of mechanical ventilation.

The study points to early mobilization of patients as a beneficial strategy that is supported by suggestive (Class III) evidence. This approach significantly shortens the length of stay in the ICU and reduces the duration of mechanical ventilation in contributing to better outcomes for critically ill patients. However, this study also underscores that none of the preventive interventions demonstrated robust evidence for reducing mortality. This emphasizes the complexity of VAP management and the need for multifaceted strategies to prevent the condition and also to improve the overall patient survival.

The beneficial results of this study suggests that incorporating SDD, NIV and early mobilization into the ventilator care bundle could revolutionize the efforts of VAP prevention. These strategies enhance the patient care by reducing the burden of VAP in critical care settings and ultimately improving the prognosis of critically ill patients.

Reference:

Zhu, D., Zhao, Q., Guo, S., Bai, L., Yang, S., Zhao, Y., Xu, Y., & Zhou, X. (2024). Efficacy of preventive interventions against ventilator-associated pneumonia in critically ill patients: an umbrella review of meta-analyses. In Journal of Hospital Infection (Vol. 145, pp. 174–186). Elsevier BV. https://doi.org/10.1016/j.jhin.2023.12.017

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Drug Safety Alert: IPC Flags ADR Linked To Cefuroxime, Nimesulide, Dutasteride plus Tamsulosin and some Beta-blockers

New Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert, has revealed adverse drug reactions linked with the popular antibiotic Cefuroxime, fixed-dose combination drug Dutasteride plus Tamsulosin, non-steroidal anti-inflammatory drug Nimesulide, and beta blockers such as Metoprolol, Propranolol, Atenolol.

In accordance with the drug safety alert, Cefuroxime which is an antibiotic, indicated for lower and upper respiratory tract infections, urinary tract infections (UTI), gynecological infections, and skin or soft tissue infections, etc can cause Acute Generalized Exanthematous Pustulosis (AGEP).

Acute generalized exanthematous pustulosis (AGEP) is a rare, acute eruption characterized by the development of numerous nonfollicular sterile pustules on a background of edematous erythema.

The warning also stated that palpitations may occur from the fixed-dose combination medication Tamsulosin + Dutasteride, which is used to treat benign prostatic hyperplasia. Dutasteride and tamsulosin combination is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign prostatic hyperplasia (BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older.

In addition to the aforementioned, the warning claimed that the non-steroidal anti-inflammatory medication nemesulide may cause fixed drug extinction (FDE). A fixed-drug eruption (FDE) is a unique cutaneous adverse drug effect in the form of recurrent lesions at the same site after re-exposure to the offending agent.

Nemesulide is used in Inflammatory conditions including joint disorders such as rheumatoid arthritis, post-traumatic and post-operative painful conditions, fever, and acute pain in Orthopaedic, ENT, Dental, and post-operative conditions. Additional indications of nimesulide include short treatment of adult patients with inflammation and pain associated with arthritis, soft tissue, ENT condition, trauma, dental pain, Musculo skeletal and gynecology, and obstetric painful conditions. It is also used for the treatment of pyrexia and inflammatory conditions in livestock.

Furthermore, the alert cited a link between reversible erectile dysfunction and beta blockers such as metoprolol, propranolol, and atenolol.

Metoprolol is used for the treatment of essential hypertension in adults, functional heart disorders, migraine prophylaxis, cardiac arrhythmias, prevention of cardiac death and reinfarction after the acute phase of myocardial infarction, and stable symptomatic CHF. Propranolol is indicated for cardiac arrhythmias; tachycardia; hypertrophic obstructive cardiac myopathy; pheochromocytoma; thrombosis; management of angina; essential and renal hypertension; and prophylaxis of migraine. Atenolol is used for the treatment of hypertension, angina pectoris, and cardiac arrhythmias.

In line with the drug safety alert beta-blockers such as Metoprolol, Propranolol, and Atenolol can cause reversible erectile dysfunction.

This came after a preliminary analysis of Adverse Drug Reactions (ADRs) from the Pharmacovigilance Programme of India (PvPI) database.

The analysis of Adverse Drug Reactions (ADRs) from the PvPI database revealed the following;

S. No.

Suspected Drugs

Indications

Adverse Drug Reactions

1

Cefuroxime

Antibiotic- Indicated for lower & upper respiratory tract infection, Urinary Tract Infection (UTI), gynecological infection, skin or soft tissue infection, etc.

Acute Generalized Exanthematous Pustulosis (AGEP)

2

Dutasteride + Tamsulosin

In the treatment of Benign Prostatic Hyperplasia

Palpitation

3

Nimesulide
  • Use in Inflammatory conditions including joint disorders such as rheumatoid arthritis, post-traumatic and post-operative painful conditions, and fever.
  • Acute pain in Orthopaedic, ENT, Dental, and Post Operative conditions.
  • Additional indication; for short treatment of adult patients with inflammation & pain associated with arthritis, soft tissue, ENT condition, trauma, dental pain, Musculo skeletal & gynecology & obstetric painful condition.
  • For the treatment of pyrexia and inflammatory conditions in livestock

Fixed Drug Eruption (FDE)

4

Beta-blockers (Metoprolol, Propranolol, Atenolol)

Metoprolol: For the treatment of essential hypertension in adults, functional heart disorders, migraine prophylaxis, cardiac arrhythmias, prevention of cardiac death and reinfarction after the acute phase of myocardial infarction, stable symptomatic CHF.

Propranolol: Cardiac arrhythmias; tachycardia; hypertrophic obstructive cardiac myopathy; pheochromocytoma; thrombosis; management of angina; essential and renal hypertension; prophylaxis of migraine.

Atenolol: For the treatment of hypertension, angina pectoris, cardiac arrhythmias

Erectile dysfunction (Reversible)

In light of the above, the Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, has advised Healthcare Professionals, Patients/Consumers to closely monitor the possibility of the above ADRs associated with the use of the above-suspected drugs.

Further, the safety alert added, “If such reaction is encountered, please report to the NCC-PvPI, IPC by filling of Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in), through Android Mobile App “ADR PvPI App” and PvPIHelpline No. 1800-180-3024 (Toll Free).”

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/drugsafetyalertsmarch2024-236152.pdf

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CDSCO Panel Approves J&J’s Protocol Amendment Proposal For Amivantamab, Lazertinib combination

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Johnson & Johnson’s proposal for the protocol amendment of the fixed-dose combination ( FDC) anti-cancer drug Amivantamab Plus Lazertinib.

This came after the firm presented protocol amendment 4 dated 14 November 2023 protocol No.73841937NSC3003. The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Amivantamab is used alone or with other drugs to treat adults with non-small cell lung cancer that has spread and has an abnormal EGFR gene. It is used in patients whose cancer has not been treated with other anticancer therapy or has gotten worse during or after platinum chemotherapy.

The synergistic mechanisms of action of amivantamab, which targets the extracellular ligand binding domain, combined with lazertinib, which targets the intracellular active site, have the potential to more potently inhibit the EGFR pathway than either agent alone.

Lazertinib is a potent, central nervous system (CNS) active, mutation-selective, third-generation TKI that targets T790M and sensitizing mutations while sparing wild-type EGFR. Preclinical studies demonstrated several potential differentiators of lazertinib over osimertinib.

At the recent SEC meeting for Oncology held on 5th March 2024, the expert panel reviewed the protocol amendment proposal presented by the drug major J&J.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read:Conduct bioequivalence study: CDSCO Panel Tells Emcure Pharmaceutical on Ferric Maltol Capsules

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CDSCO Panel Approves Roche’s Protocol Amendment Proposal For Anti-cancer Drug Atezolizumab, Lenvatinib, and Sorafenib Study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Roche’s proposal for the protocol amendment of the Clinical trial titled “A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab”.

This came after the firm presented protocol amendment version 4 dated 09 November 2022 and protocol amendment version 5 dated 31 March 2023 protocol no. MO42541. This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

Atezolizumab injection is used alone to help prevent non-small cell lung cancer (NSCLC) from coming back in patients whose tumor has been removed by surgery and who have received other cancer medicines (eg, platinum). It is given to patients who have stage 2 to stage 3A NSCLC and whose tumors express PD-L1.

Lenvatinib is FDA-approved for the treatment of radioactive iodine-refractory differentiated thyroid cancer (DTC), unresectable or advanced hepatocellular carcinoma (HCC), and advanced renal cell carcinoma (RCC). It is a multiple receptor tyrosine kinase inhibitor that demonstrates potent antiangiogenic properties.

Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body. Sorafenib is an antineoplastic (cancer) agent.

At the recent SEC meeting for Oncology on 5th March 2024, the expert panel reviewed the proposal amendment version 4 dated 09 November 2022, and protocol amendment version 5 dated 31 March 2023 protocol no. MO42541 .

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read: Biocon Biologics, CSSC collaborate for Mission 10 cents

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Applications Open: Assistant Professor Post At Kerala Public Service Commission, Apply Now

Kerala: The Kerala Public Service Commission (KPSC) has released Vacancies for Assistant Professor posts on Direct Recruitment Basis in Medical Education Department. The selection will be done based on the written exam and interview. 

KPSC is a body created by the Constitution of India. The Commission advise the Government on all matters relating to civil services referred to it under Article 320 (3) of the Constitution and publish notifications inviting applications for selection to various posts as per the requisitions of the appointing authorities, conduct written test and/or practical tests, physical efficiency test and interview, prepare ranked list based on the performance of the candidates and advise candidates for appointment strictly based on their merit and observing the rules of reservation as and when vacancies are reported. The Head Office of the Kerala Public Service Commission is situated at Pattom, Thiruvananthapuram, the State Capital.

KPSC Vacancy Details:

Total no of vacancies: 19

The Vacancies are in the department of Cardio Vascular and Thoracic Surgery, and Emergency Medicine.

Last Date of Application: 2nd May 2024.

For more details about Qualifications, Age, Pay Allowance, and much more, click on the given link:
https://medicaljob.in/jobs.php?post_type=&job_tags=kpsc&location=&job_sector=all

Method of Submitting Applications:-

a) Candidates must register as per ‘ONE TIME REGISTRATION’ with the Official Website of Kerala Public Service Commission www.keralapsc.gov.in before applying for the post. Candidates who have registered can apply by logging on to their profile using their User-ID and password. Candidates must click on the ‘Apply Now’ button of the respective posts in the Notification Link to apply for the post. The photograph uploaded should be one taken after 31.12.2014. Candidates who have created new Profile from 01.01.2024 should upload their Photograph taken within a period of 6 months. Name of the candidate and the date of photograph taken should be printed legibly at the bottom portion. The photograph once uploaded meeting all requirements shall be valid for 10 years from the date of uploading.

(b) There is no change in other instructions regarding the uploading of photographs. No application fee is required. Candidates are responsible for the correctness of the personal information and secrecy of password. Before the final submission of the application on the profile candidates must ensure correctness of the information in their profile. They must quote the User-ID for further communication with the Commission. Application submitted is provisional and cannot be deleted or altered after submission. Candidates are advised to keep a printout or soft copy of the online application for future reference. Candidates can take the print out of the application by clicking on the link `My applications’ in their profile. All correspondence with the Commission, regarding the application should be accompanied with the print out of the application.

(c) The application will be summarily rejected if noncompliance with the notification is found in due course of processing. Original Documents to prove qualification, experience, age, Community etc. have to be produced as and when called for. The profile correction made by the candidates themselves or through the office of the KPSC on request after the last date fixed for the receipt of applications will not be reflected in the application. Such corrections will come into effect only on the date on which corrections have been made.

(d) If written/OMR/Online Test is conducted as part of this selection, candidates shall submit a confirmation for writing the examination through their One Time Registration Profile. Such candidates alone can generate and download the Admission Tickets in the last 15 days till the date of Test. The applications of candidates who do not submit confirmation within the stipulated period, will be rejected absolutely. The periods regarding the submission of confirmation and the availability of Admission Tickets will be published in the Examination Calender itself. Information in this regard will be given to the candidates in their respective profiles and in the Mobile Phone Number rgistered in it.

(e) “Candidates who have AADHAAR Card should add AADHAAR as ID Proof in their profile.”

Also Read:Vacancies For Assistant Professor: Walk In Interview At RML Hospital Delhi, View All Details Here

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