Surgery best option for treating nodular primary localized cutaneous amyloidosis, states research

A new study published in the journal of Clinical and Experimental Dermatology showed that for non-nodular primary localized cutaneous amyloidosis (PLCA), laser therapy is recommended, but surgery is the most effective treatment for nodular amyloidosis.

Amyloid buildup in the dermis without systemic involvement is the hallmark of primary localized cutaneous amyloidosis which is an uncommon skin condition. Instead of coming from immunoglobulin or serum protein deposits as in systemic types of amyloidosis, amyloid in PLCA is formed from the keratin peptides of necrotic keratinocytes.

Amyloid development in the skin is thought to be caused by the deposition of filamentous material as a result of severe scratching brought on by pruritogenic processes. Atopic dermatitis is one condition where chronic scratching can lead to keratinocyte destruction and localized amyloid development. This study was set to review the existing treatment approaches and to offer a modern viewpoint on PLCA therapy.

This study examined the Cochrane Library, EMBASE, and PubMed databases for relevant articles. While case reports and case series were assessed using the Mann-Whitney U test, cohort studies were meta-analyzed using a random effects model to assess the results of various therapies.

In all, a total of 535 patients from 117 trials were included. With statistically significant differences for the other treatments, surgery was the preferred treatment for nodular amyloidosis (NA). 20 cohort studies (418 patients) and 62 case-level studies (79 patients) were examined independently for the non-NA group. Biological medicines and JAK inhibitors may be viable treatment for refractory lesions, despite the fact that the case-level studies did not find any statistically significant differences between regimens.

Transcutaneous electrical nerve stimulation, topical therapies, laser therapies, micro-needling, and systemic immunosuppressants had partial response (PR) rates of 100.0%, 100.0%, 97.5%, 96.9%, and 94.4%, respectively, while surgical procedures and laser therapies had complete response (CR) rates of 22.2% and 2.5%.

Overall, the study found surgery to be the best course of action for NA individuals, whereas laser treatment is advised for non-NA patients. For lesions that do not improve with traditional treatments, biologic medicines and JAK inhibitors could be interesting alternatives. JAK inhibitors and biological agents offer potential for refractory lesions. Also, a 100% partial response rate was obtained using transcutaneous electrical nerve stimulation and micro-needling which demonstrated a range of PLCA therapy alternatives.

Source:

Wang, Q.-X., Ye, Q., Zhou, K.-Y., Luo, S.-Y., & Fang, S. (2025). A systematic review and meta-analysis of treatments and outcomes of primary localized cutaneous amyloidosis. Clinical and Experimental Dermatology. https://doi.org/10.1093/ced/llaf081

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Psychosocial Interventions reduce depressive symptoms among Chronic Kidney Disease Patients: Study

Researchers in a new study have highlighted the positive impact of psychosocial interventions on patients with chronic kidney disease, emphasizing their role in improving patient well-being and outcomes.

Depression is prevalent among individuals with chronic kidney disease (CKD) and those undergoing dialysis, with significant impacts on morbidity and mortality. This systematic review and meta-analysis was done to evaluate the efficacy of psychosocial interventions in managing depressive symptoms in patients with chronic kidney disease. This systematic review and meta-analysis adhered to PRISMA guidelines. A literature search was conducted across PubMed, Embase, Google Scholar, and Cochrane Library databases from January 2007 to July 2024. Randomized controlled trials (RCTs) investigating psychosocial interventions in chronic kidney disease patients (Stage 4 or 5 or on hemodialysis) were included. The primary outcome was the change in depressive symptoms, measured by standardized clinical tools. Quality of life was a secondary outcome. Data extraction and bias assessment were conducted using ROB-2 and GRADEpro GDT tools. Results: Twelve studies with a total of 792 participants (420 in the intervention group and 372 in the control group) were included. Cognitive-behavioral therapy (CBT) was the most common intervention. Psychosocial interventions significantly reduced depressive symptoms compared to routine care (mean difference [MD]: −4.22; 95% CI: −6.67, −1.76; P = 0.0008). High heterogeneity (I2 = 89%) was noted. Sensitivity analysis confirmed the robustness of the results. The impact on quality of life was not statistically significant (MD: 0.94; 95% CI: −0.61, 2.49; P = 0.24). Moderate-quality evidence suggests that psychosocial interventions effectively reduce depressive symptoms in chronic kidney disease patients. While no significant improvement in quality of life was observed, these interventions provide an alternative to pharmacological treatments, potentially minimizing drug-related side effects

Reference:

Chahal JS, Saini S, Bansal P, et al. Impact of Psychosocial Interventions on Depression in Chronic Kidney Disease: A Systematic Review and Meta-Analysis. The International Journal of Psychiatry in Medicine. https://doi.org/10.1177/00912174251326009

Keywords:

Psychosocial, Interventions, Benefit, Chronic Kidney Disease, Patients, Study, Chahal JS, Saini S, Bansal P

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Epidural Steroid Injections for Back Pain Treatment offer mixed results: AAN

A review by the American Academy of Neurology (AAN) has found that epidural steroid injections (ESIs) provided short-term relief for patients with radiculopathy. However, their effectiveness in other cases was unclear or limited, with minimal impact on reducing overall back pain and disability. The recent study was conducted by Carmel A. and fellow researchers.

ESIs are commonly used for managing pain and disability associated with cervical and lumbar spinal stenosis and radiculopathies. While ESIs have been widely adopted, their long-term effectiveness remains uncertain. This systematic review evaluated evidence from 90 RCTs conducted between January 2005 and January 2021, aiming to clarify the extent of pain relief and functional improvement achieved through ESIs.

The researchers conducted a search of multiple databases for RCTs evaluating the effectiveness of ESIs in cervical and lumbar spinal stenosis and radiculopathies. Because of the large variability in outcome measures across studies, SRD was used to synthesize data standardized for analysis. NNT was also computed for clinical interpretation. The outcomes of short-term and long-term pain and disability measurements were evaluated to determine the efficacy of ESIs.

Key Findings

  • In cervical and lumbar radiculopathies, ESIs probably reduce short-term pain (SRD -24.0%, 95% CI −34.9 to −12.6, NNT 4) and short-term disability (SRD −16.0%, 95% CI −26.6 to −5, NNT 6).

  • ESIs possibly reduce long-term disability in radiculopathies (SRD −11.1%, 95% CI −25.3 to 3.6, NNT 9).

  • There is insufficient evidence to confirm that ESIs reduce long-term pain in radiculopathies (SRD −10.3%, 95% CI −27.8 to 7.6).

  • In lumbar spinal stenosis, ESIs possibly reduce short-term disability (SRD −26.2%, 95% CI −52.4 to 3.6, NNT 4) and long-term disability (SRD −11.8%, 95% CI −26.9 to 3.8, NNT 8).

  • However, ESIs do not significantly reduce short-term pain in lumbar stenosis (SRD −3.5%, 95% CI −12.6 to 5.6).

  • There is insufficient evidence to determine whether ESIs reduce long-term pain in lumbar stenosis (SRD −6.5%, 95% CI −22.5 to 9.8).

  • In cervical spinal stenosis, evidence is insufficient to determine the effectiveness of ESIs for either pain or disability.

The study authors concluded that ESIs provide only limited benefits in managing pain and disability in cervical and lumbar radiculopathies, with some possible effectiveness in lumbar spinal stenosis, particularly in the short term. Given the variability in outcome measures, further high-quality research is needed to establish the true clinical effectiveness of ESIs.

Reference:

Armon, C., Narayanaswami, P., Potrebic, S., Gronseth, G., Bačkonja, M.-M., Cai, V. L., Dorman, J., Gilligan, C., Heller, S. A., Silsbee, H. M., & Smith, D. B. (2025). Epidural steroids for cervical and lumbar radicular pain and spinal stenosis systematic review summary: Report of the AAN guidelines subcommittee. Neurology, 104(5). https://doi.org/10.1212/wnl.0000000000213361

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Can long-term use of anti-inflammatory medications prevent dementia?

Past research has suggested that inflammation may contribute to the development and progression of dementia and that non-steroidal anti-inflammatory (NSAID) medications may help protect against dementia due to their anti-inflammatory effects. A new large prospective study published in the Journal of the American Geriatrics Society provides additional evidence, showing that long-term NSAID use is linked to a decreased risk of developing dementia.

In the population-based study of 11,745 adults with an average follow-up of 14.5 years, 9,520 participants had used NSAIDs at any given time, and 2,091 participants developed dementia. Long-term NSAID use was associated with a 12% reduced risk of developing dementia. Short- and intermediate-term use did not provide benefits. Also, the cumulative dose of NSAIDs was not associated with decreased dementia risk.

The findings suggest that prolonged, rather than intensive, use of anti-inflammatory medications may help protect against dementia.

“Our study provides evidence on possible preventive effects of anti-inflammatory medication against the dementia process. There is a need for more studies to further consolidate this evidence and possibly develop preventive strategies,” said corresponding author M. Arfan Ikram, MSc, MD, PhD, of Erasmus MC University Medical Center Rotterdam, in the Netherlands.

Reference:

vom Hofe, I., et al. (2025) Long-Term Exposure to Non-Steroidal Anti-Inflammatory Medication in Relation to Dementia Risk. Journal of the American Geriatrics Society. doi.org/10.1111/jgs.19411.

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Glycosylated Fibronectin May be Potential Biomarker for Preeclampsia Diagnosis: Study Finds

China: A recent meta-analysis published in BMC Pregnancy and Childbirth confirmed a significant increase in serum glycosylated fibronectin (GlyFn) levels in preeclampsia (PE) and highlighted its high diagnostic accuracy. These findings suggest that GlyFn could be a promising biomarker for PE’s screening and diagnosis.

Preeclampsia, characterized by high blood pressure and organ dysfunction during pregnancy, remains a major cause of maternal and neonatal morbidity. Early detection is crucial for effective management, yet current diagnostic methods rely on clinical symptoms that may appear late in the disease process. Identifying reliable biomarkers could enhance early diagnosis and improve outcomes for at-risk pregnant individuals.

Studies have indicated that maternal serum glycosylated fibronectin levels are significantly higher in individuals with preeclampsia than those without the condition. This elevation suggests GlyFn’s potential as a novel biomarker for PE screening and diagnosis. Building on this evidence, Rong Zhou, NHC Key Laboratory of Chronobiology, Sichuan University, Chengdu, China, and colleagues seek to assess GlyFn levels in maternal serum and determine their diagnostic accuracy in detecting PE.

For this purpose, the researchers conducted a systematic literature search across PubMed, EMBASE, Web of Science, and the Cochrane Library until January 15, 2024. Study quality was assessed using the Newcastle-Ottawa Scale and the QUADAS-2 tool. Heterogeneity was analyzed using I² statistics. Standardized mean differences with 95% confidence intervals were calculated to compare maternal serum GlyFn levels between PE and controls. Sensitivity, subgroup analyses, and publication bias assessments ensured result reliability. Diagnostic accuracy was evaluated using pooled sensitivity, specificity, and the area under the summary receiver operating characteristic curve.

Key Findings

  • The meta-analysis included 11 studies assessing maternal serum GlyFn levels in preeclampsia.
  • GlyFn levels were significantly higher in the PE group compared to the control group (SMD = 1.08).
  • Heterogeneity was observed, potentially due to detection and study design variations.
  • The pooled sensitivity and specificity of GlyFn for diagnosing PE were 0.81 and 0.80, respectively.
  • The overall diagnostic accuracy, measured by the area under the curve, was 0.90.

In conclusion, the meta-analysis confirmed that maternal serum GlyFn levels are significantly elevated in preeclampsia and demonstrate high diagnostic accuracy, highlighting its potential as a reliable biomarker for early detection.

The researchers suggest, that “incorporating GlyFn into screening strategies could offer a faster, more accurate, and cost-effective approach to diagnosing PE, ultimately benefiting maternal and fetal health.” However, they stress the need for further large-scale, longitudinal studies to refine diagnostic thresholds and validate clinical utility for routine practice.

Reference:

Liao, L., Liu, M., Yin, Y. et al. Glycosylated fibronectin in preeclampsia: a systematic review and meta-analysis. BMC Pregnancy Childbirth 25, 228 (2025). https://doi.org/10.1186/s12884-025-07243-6

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Acupuncture with Medication Promising for COPD Treatment: Study Finds

China: A recent multicenter randomized controlled trial has highlighted the potential benefits of acupuncture as a complementary therapy for patients with chronic obstructive pulmonary disease (COPD).

The study, published in Complementary Therapies in Medicine, found that combining acupuncture with conventional drug treatment led to significant improvements in exercise capacity, quality of life, and breathlessness reduction compared to using either approach alone.

COPD, a progressive lung disease that causes breathing difficulties, is typically managed with medications such as bronchodilators and corticosteroids. However, the researchers note that many patients experience persistent symptoms that impact their daily lives. Acupuncture has shown therapeutic benefits for patients with chronic obstructive pulmonary disease, but its effectiveness compared to medications remains unclear.

Considering this, Jiansheng Li, Henan University of Chinese Medicine, Zhengzhou, Henan, China, and colleagues aimed to assess the effectiveness and safety of acupuncture, conventional drugs, and their combination in treating COPD.

For this purpose, the researchers conducted a multicenter, open-label randomized controlled trial using a central randomization system. A total of 150 COPD patients were randomly assigned in a 1:1:1 ratio to receive either acupuncture, conventional drug treatment, or a combination of both for 12 weeks, followed by a 12-week observation period without treatment. The primary outcomes measured were the six-minute walk distance (6MWD) and St. George’s Respiratory Questionnaire (SGRQ), while secondary outcomes included the modified Medical Research Council (mMRC) dyspnea scale, acute exacerbations, lung function, and quality of life assessed through the COPD Assessment Test.

The following were the key findings of the study:

  • The study included one-fifty patients, with 143 completing the trial.
  • There were significant time, group, and interaction effects among the three groups.
  • The acupuncture plus conventional drug group showed a significant increase in six-minute walk distance (6MWD) at 4, 8, and 12 weeks of treatment, as well as at 12 weeks of follow-up, compared to the conventional drug group.
  • Symptom scores, motor scores, impact scores, and total St. George’s Respiratory Questionnaire (SGRQ) scores changed over time across all groups, showing a time effect. However, there was no significant group or interaction effect.
  • Among secondary outcomes, time effects were observed in the number of acute exacerbations, forced expiratory volume in one second (FEV1), and the FEV1/forced vital capacity (FEV1/FVC) ratio across all groups.
  • The modified Medical Research Council (mMRC) dyspnea scale showed time and group effects.
  • The COPD Assessment Test (CAT) demonstrated significant time, group, and interaction effects.

“The study findings align with expectations, showing that combining acupuncture with conventional drug treatment is more effective than using either approach alone for managing stable COPD. This combination improves exercise capacity, enhances quality of life, and reduces breathlessness while being a safe and well-tolerated complementary treatment,” the researchers wrote.

“These results highlight the potential of acupuncture as an adjunct therapy and encourage further research on its benefits in COPD management,” they concluded.

Reference:

Li, J., Xie, Y., Wang, Y., Wu, L., Yu, X., Bai, L., Shao, S., Zhou, M., Zhang, M., Yu, X., Han, W., Li, X., & Chen, T. (2025). Effect of acupuncture on patients with chronic obstructive pulmonary disease: A multicenter randomized controlled trial. Complementary Therapies in Medicine, 89, 103146. https://doi.org/10.1016/j.ctim.2025.103146

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MP Medical Council FMG Clinical Clerkship, Internship Counselling FAQs released, details

Madhya Pradesh- The registration process for MP Medical Council FMG Clinical Clerkship/Internship Counselling (December 2024) is currently ongoing. In this regard, MPDME has released a notification regarding Frequently Asked Questions (FAQs) by the candidates for counselling.

As per the notification, there are a total of 6 key questions which have been frequently asked by the candidates regarding the MPMC-FMG Clinical Clerkship/Internship Counselling for December 2024.

Below are the FAQs-

Q1 I have not yet received my FMGE Pass Certificate from NBE. What should I do?

A Candidates who have not received their FMGE Pass Certificate can use their FMGE Scorecard to apply for an internship in Madhya Pradesh (MP) State. Once you receive your FMGE Pass Certificate, you must get it verified and submit a copy of the same at your respective college.

Q2 What should candidates do if they have a NEET Scorecard instead of an Eligibility Certificate?

A Exceptions have been made regarding the eligibility certification for the 2013 and 2018 batches. The NMC has not issued eligibility certificates for these batches, but instead, the NEET Passing Certificate or Score Card is recognized as their Eligibility Certificate for the 2018 batch.

Candidates who have a NEET Scorecard instead of an Eligibility Certificate can-

i Fill in the NEET Roll Number in place of the certificate number.

ii Use the passing date in place of the certificate date.

iii Upload the NEET Scorecard in place of the Eligibility Certificate.

Q3 The guidelines mention a Provisional Registration Receipt. Is it required at the time of joining?

A Candidates are eligible to apply for provisional registration after joining their internship. Therefore, at the time of college admission, they may exclude the provisional registration receipt and inform the college authorities that they will apply for it after starting their internship.

During the verification process, colleges are requested to omit the verification of the provisional registration receipt.

Q4 Is the Domicile Certificate compulsory?

A i MP State Domicile- Candidates who are domiciled in Madhya Pradesh (MP) State must submit their domicile certificate.

ii Non-MP Domicile- Candidates from other states can submit their own state domicile certificate if available. If they do not have a domicile certificate from their state, they must submit a self-declaration stating that they are not from MP and do not currently have their state domicile certificate.

Applicants who have been granted merit due to MP domicile must produce a valid MP Domicile Certificate, otherwise, they lose their candidature.

Q5 Is an Affidavit compulsory?

A Yes, a self-undertaking affidavit is compulsory. The affidavit must-

i Be notarized.

ii Be on a 50/- stamp paper for MP candidates.

iii For non-MP candidates, it should be made on the requisite stamp paper as per their state’s regulations.

Q6 The candidates who want to cancel their admission by themselves or cancellation by college due to any discrepancy found.

A In cases where a candidate wishes to cancel their admission or if the college cancels the admission due to any discrepancies found, the college must obtain a written undertaking from the candidate confirming the cancellation. The college should then generate a cancellation slip, print it, clearly state the reason for cancellation (e.g., eligibility issue, discrepancy found, or voluntary withdrawal), and obtain the candidate’s signature for confirmation.

Meanwhile, the online registration by eligible candidates of FMGE Dec 2024 on the MPMC-DME portal is already ongoing which will end on 16 March 2025 up to 11:59 PM. Below is the complete schedule-

SCHEDULE

S.NO

EVENT

DURATION

NO. OF DAYS

1

Online Registration by eligible candidates of FMGE Dec 2024 on the MPMC-DME portal.

05 to 16 March 2025 (up to 11:59 PM)

12 Days

2

Edit in Registration Form.

05 to 16 March 2025 (up to 11:59 PM)

3

Publication of Vacancies/Seats.

10 March 2025

2 Days

4

Invitation of objection against vacancies from respective colleges.

10 to 11 March 2025 (05:00 PM)

5

Disposal of objection and publication of final vacancies.

12 March 2025

1 Day

6

Publication of Merit list of registered candidates.

17 March 2025

1 Day

7

Choice filling and locking by registered candidates.

18 to 23 March 2025 (up to 11:59 PM)

5 Days

8

Edit in Choice Filling and Locking.

18 to 23 March 2025 (up to 11:59 PM)

9

Allotment Result.

25 March 2025

10

Reporting at allotted Medical college in person for document verifications and admission.

26 to 31 March 2025 (up to 05:00 PM)

6 Days

11

Online Resignation/Cancellation of admission at college level.

26 to 31 March 2025 (up to 05:00 PM)

6 Days

To view the notification, click the link below

https://medicaldialogues.in/pdf_upload/mpdme-277599.pdf

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Pitt study makes new insights into origins of ovarian cancer

Researchers at the University of Pittsburgh have identified a novel trigger of a deadly form of ovarian cancer: a subset of progenitor cells that reside in fallopian tube supportive tissue, or stroma.

The discovery of these high-risk cells, described in a new study published in Cancer Discovery, a journal of the American Association for Cancer Research, could pave the way for better approaches to prevent and detect high-grade serous ovarian cancer (HGSOC), the most common form of ovarian cancer, which kills more than 12,000 women in the U.S. each year.

“Ovarian cancer is the leading cause of death from gynecologic cancer in the Western world, but we currently have no way to detect it early and no prevention strategies apart from surgical castration, which is only indicated in high-risk women,” said co-senior author Lan Coffman, M.D., Ph.D., associate professor of malignant hematology and medical oncology in the Pitt School of Medicine and member of Magee-Womens Research Institute and UPMC Hillman Cancer Center. “Understanding the underlying biology of how ovarian cancer forms is critical to improving outcomes for our patients.”

HGSOC begins in the fallopian tubes when healthy epithelial cells transform into precursor lesions known as serous tubal intraepithelial carcinoma (STIC). Similar to how precancerous colon polyps can become colorectal cancer, STIC lesions often develop into HGSOC tumors.

But why do healthy cells become STIC? To find out, Coffman and her team turned to the stroma, the non-cancerous connective tissue that helps cancer grow.

“Most researchers have been focused on the epithelial cells that turn into these STIC lesions and eventually into cancer,” said Coffman. “Until now, no one has really looked at the surrounding stromal microenvironment of these lesions.”

In the stroma of ovarian cancer, a type of progenitor cell normally involved in growth and repair of healthy tissue-mesenchymal stem cells (MSCs)-become reprogrammed by tumor cells to support cancer growth. Coffman started by asking when these cancer-associated MSCs form and how early they play a role in cancer formation.

When she and her team profiled MSCs in the fallopian tubes of patients who did not have cancer, they were surprised to find cells that looked like cancer-associated MSCs in these healthy women. These cells, which the researchers named high-risk MSCs, were more common in women with higher risk of ovarian cancer-those of older age or with mutations in the BRCA gene-suggesting that they play a role in cancer initiation.

When the researchers introduced these high-risk MSCs into organoids, or mini organs, derived from patient fallopian tube tissue, healthy epithelial cells transformed into cancerous cells.

“High-risk MSCs promote DNA damage in epithelial cells and then help those mutated cells survive,” explained Coffman. “It’s the perfect storm for cancer initiation.”

High-risk MSCs also promoted tumor cell growth and increased resistance to a chemotherapy drug.

In search of a mechanism for why high-risk MSCs drive ovarian cancer, the researchers found that these cells have loss of an antioxidant called AMP kinase. Lower levels of AMP kinase led to higher levels of a protein called WT1, which in turn drove formation of compounds that cause DNA damage.

“This is the first report that stromal changes in the fallopian tube actually have a causative role in ovarian cancer initiation,” said Coffman. “It also points to a path where we might be able to intervene.”

For example, already existing drugs that upregulate AMP kinase could potentially prevent or reverse early changes in the stroma that lead to ovarian cancer.

The findings could also inform approaches for early detection, which are sorely lacking for ovarian cancer. According to Coffman, compounds secreted by high-risk MSCs that are detectable in the bloodstream could act as biomarkers for early-stage ovarian cancer.

Reference:

 Aged and BRCA mutated stromal cells drive epithelial cell transformation, Cancer Discovery (2025).

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Fee concession at Rohilkhand Medical College for 6 PG Medical courses announced, check details

Uttar Pradesh- Through a recent notice, the Uttar Pradesh, Director General, Medical Education and Research (UPDGME) has informed regarding fee concession at Rohilkhand Medical College and Hospital for postgraduate (PG Medical) courses for the academic year 2024-25.

As per the letter, Rohilkhand Medical College & Hospital, Bareilly has decided to offer a concession on the fee structure for certain Medical Postgraduate (MD/MS) subjects. This initiative aims to make medical education more accessible and support aspiring professionals in their advanced studies.

Fee concession has been given in total 6 PG medical courses such as Microbiology, Community Medicine, Pharmacology, Biochemistry, Physiology and Anatomy. Earlier the tuition fee fixed by the fee fixation committee of UP government for 6 courses for 2024-25 was Rs 8,88.056/- but now the tuition fee has been fixed by the college for the session (2024-25) as Rs 1,00,000/- for Microbiology and Community Medicine and Rs 50,000/- for Pharmacology, Biochemistry, Physiology and Anatomy courses.

Therefore, in this regard, Rohilkhand Medical College and Hospital has requested UPDGME to publish the revised fee structure for 6 PG medical courses on its official website. This will ensure that students across the state are well-informed and can avail the opportunity accordingly.

The Department of Medical Education plays a pivotal role in developing medical and para-medical personnel to cater to the state’s health needs. The department also has a role to play in establishing and maintaining well-equipped teaching institutions, which are the premier referral centres from peripheral hospitals. Research is another area of activity for the medical education department. The directorate facilitates comprehensive medical and dental education via various medical, dental and paramedical colleges in the state of Uttar Pradesh. On the other hand, it also provides standard medical facilities to the patients. 

To view the letter, click the link below

https://medicaldialogues.in/pdf_upload/rohilkhand-medical-college-seeks-updgme-approval-for-pg-medical-fee-concession-278472.pdf

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Dr Reddy’s Laboratories gets CDSCO Panel nod to study Rabeprazole Sodium Modified Release Capsules

New Delhi: Dr. Reddy’s Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a Phase III clinical trial study of Rabeprazole Sodium Modified Release Capsules 40 mg.

This came after Dr. Reddy’s Laboratories presented a comparative bioavailability study report and Phase III clinical trial protocol before the committee.

Rabeprazole is an antiulcer drug in the class of proton pump inhibitors. It is a prodrug—in the acid environment of the parietal cells it turns into active sulphenamide form. Rabeprazole inhibits the H+, K+ATPase of the coating gastric cells and dose-dependently suppresses basal and stimulated gastric acid secretion.

Rabeprazole is used to treat duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome, a condition where the stomach produces too much acid. It may also be used together with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers associated with infections caused by H. pylori.

At the recent SEC meeting for gastroenterology and hepatology held on February 27, 2025, the expert panel reviewed the comparative bioavailability study report and Phase III clinical trial protocol.

After detailed deliberation, the committee considered the comparative bioavailability study report and recommended the grant of permission to conduct a Phase III clinical trial study as per the protocol presented by the firm.

Also Read: CDSCO Panel suggests revising phase III CT protocol of Zydus Healthcare’s Empagliflozin plus Metoprolol Succinate FDC

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