Single serum hCG level 16 days after ovulation useful predictor of pregnancy outcome, suggests study

After assisted reproductive technology (ART) cycles,
elevated serum hCG at 16 days after ovulation is used as an endocrine marker of
pregnancy. Whether the pregnancy is ongoing is uncertain at this stage.
Diagnosis of pregnancy has both emotional and practical implications for the
pregnant woman, her family, and health care practitioners. Early diagnosis with
knowledge of prognostic outcome has the potential to reduce the stress often
associated with the uncertainty of outcome in ART treatment. The pregnancy test
under evaluation was obtained from a single blood test taken 16 days after
ovulation, which is assayed for levels of hCG and progesterone. Human chorionic
gonadotropin is secreted from the implanting blastocyst and appears in maternal
blood approximately 6–8 days after fertilization.

It would be beneficial for the patient, her family, and the
clinical team to have a reliable prognostic marker of pregnancy outcome at this
early stage. For the patient, ART treatment is often stressful, and waiting for
pregnancy test results can be a time of tension and uncertainty. Information
provided by staff to patients may be inconsistent or nonspecific, causing
further stress and uncertainty.

The objective of this retrospective study study by Gillian
Homan was to assess the predictive value on pregnancy outcome based on serum
hCG and progesterone levels 16 days after ovulation. Other factors, such as
treatment method, ovarian stimulation, luteal support, and age, were also
included in the analysis.

The data were obtained from two integrated Adelaide-based
clinics: the Queen Elizabeth Hospital and Wakefield Clinic. Patient(s): Women
who have achieved a pregnancy through ART treatment. Analysis of data using
logistic regression (STATA v.5.0) to predict a binary outcome: ongoing
pregnancy or miscarriage. Ongoing pregnancy was defined as progression to >20
weeks’ gestation. Miscarriage included spontaneous abortion, biochemical and
ectopic pregnancies, and blighted ovum.

Human chorionic gonadotropin was found to be the main
determinant of ongoing pregnancy. Age and progesterone had minor effects,
whereas stimulation, luteal support, and treatment types were nonpredictive.
Low hCG levels between 25 and 50 IU/L are associated with a low probability of
ongoing pregnancy (<35%), whereas levels of >500 IU/L predict a >95%
chance of ongoing pregnancy.

This study confirms the hypothesis that serum levels of hCG
in samples taken 16 days after ovulation are powerful predictors of good or
poor pregnancy outcome. Because of the large sample size, statistical modeling
could predict with precision, on the basis of the hCG level alone, the
probability of ongoing pregnancy. The strength of the relationship was
sufficient to allow its use at a clinical level for the prediction of pregnancy
outcome to the exclusion of all other markers.

In conclusion, a single serum sample taken and assayed 16
days after ovulation, following ART treatment, is clinically useful in
predicting pregnancy outcome. This is valuable information for both patients
and practitioners, because it does reduce anxiety and provide a basis for early
pregnancy management and monitoring. The findings of this study could be
included in a patient information sheet, because the relationship between the
level of hCG, age, and the predictive value of pregnancy outcome is
comprehensible to patients. This study included all ART treatment cycles;
therefore, this information can be used for all patients in units where a
variety of ART procedures are practiced.

Source: Gillian Homan, B.N., Susan Brown, R.N., John Moran; FERTILITY
AND STERILITY

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Losartan hydrogel may decrease size of scar and remodel tissue to enhance wound repair: Study

Losartan hydrogel may decrease size of scar and remodel tissue to enhance wound repair suggests a study published in the Journal of Biomaterials Applications.

Skin tissue engineering has become an increasingly popular alternative to conventional treatments for skin injuries. Hydrogels, owing to their advantages have become the ideal option for wound dressing, and they are extensively employed in a mixture of different drugs to accelerate wound healing. Sodium alginate is a readily available natural polymer with advantages such as bio-compatibility and a non-toxicological nature that is commonly used in hydrogel form for medical applications such as wound repair and drug delivery in skin regenerative medicine. Losartan is a medicine called angiotensin receptor blocker (ARB) that can prevent fibrosis by inhibiting AT1R (angiotensin II type 1 receptor). In this research, for the first time, three-dimensional scaffolds based on cross-linked alginate hydrogel with CaCl2 containing different concentrations of losartan for slow drug release and exudate absorption were prepared and characterized as wound dressing. Alginate hydrogel was mixed with 10, 1, 0.1, and 0.01 mg/mL of losartan, and their properties such as morphology, chemical structure, water uptake properties, biodegradability, stability assay, rheology, blood compatibility, and cellular response were evaluated. In addition, the therapeutic efficiency of the developed hydrogels was then assessed in an in vitro wound healing model and with a gene expression. The results revealed that the hydrogel produced was very porous (porosity of 47.37 ± 3.76 µm) with interconnected pores and biodegradable (weight loss percentage of 60.93 ± 4.51% over 14 days). All hydrogel formulations have stability under various conditions. The use of CaCl2 as a cross-linker led to an increase in the viscosity of alginate hydrogels. An in vitro cell growth study revealed that no cytotoxicity was observed at the suggested dosage of the hydrogel. Increases in Losartan dosage, however, caused hemolysis. In vivo study in adult male rats with a full-thickness model showed greater than 80% improvement of the primary wound region after 2 weeks of treatment with alginate hydrogel containing 0.1 mg/mL Losartan. RT-PCR and immunohistochemistry analysis showed a decrease in expression level of TGF-β1 and VEGF in treatment groups. Histological analysis demonstrated that the alginate hydrogel containing Losartan can be effective in wound repair by decreasing the size of the scar and tissue remodeling, as evidenced by future in vivo studies.

Reference:

Zamani S, Salehi M, Abbaszadeh-Goudarzi G, et al. Evaluation effect of alginate hydrogel containing losartan on wound healing and gene expression. Journal of Biomaterials Applications. 2024;0(0). doi:10.1177/08853282241292144

Keywords:

Losartan, hydrogel, may, decrease, size, scar, remodel, tissue, enhance , wound, repair, Study , Journal of Biomaterials Applications, Zamani S, Salehi M, Abbaszadeh-Goudarzi G

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Study finds direct correlation between number of eggs at retrieval and pregnancy rate among women above 40

In August 2010 the Quebec Government funded the costs of in
vitro fertilization in exchange for greater use of single embryo transfer. As a
result, stimulation protocols became gentler. S. Ouhilal et al sought to
determine the optimal number of eggs at oocyte retrieval by carrying out a
Cohort study.

Authors compared the number of eggs at oocyte retrieval and
the clinical pregnancy rate in all our fresh stimulated cycles between August
2010 and December 2012. The number of eggs at retrieval were divided as
follows: 1–4 eggs, 5 to 9 eggs, 10–14 eggs, 15–19 eggs, >20 eggs. Data was
subdivided based on age less than 35, age 35-39, and age 40 and over.

A total of 1615 consecutive stimulated fresh IVF cycle starts
that resulted in retrieval of at least one egg were analyzed. In women age less
than 35 (n=590), the clinical pregnancy rate was optimal (≥44%)
when there were at least 10 eggs at retrieval. For women with 1–4 eggs at
retrieval it was 30.8% and for 5–9 eggs it was 36.2%. In women age 35–39 (n=543),
optimal pregnancy rates (34.8%) were achieved with 5–9 eggs at retrieval. Less
than 5 eggs significantly reduced the pregnancy rate (15.6%) whereas more than
10 eggs yielded pregnancy rates between 28 and 29%. In women over 40 (n=482),
authors found a stepwise improvement in pregnancy rates with increased number
of eggs at retrieval (1–4: 11%, 5–9: 21%, 10–14: 26%, 15–19: 33%).

In women 40 and over, there is a direct correlation between
the number of eggs at retrieval and pregnancy rate whereas in women age less
than 35 there was no improvement in pregnancy rates beyond 10 eggs.
Interestingly, in women age 35 to 39, a modest number of eggs at retrieval
(5–9) is associated with the best outcomes.

Source: S. Ouhilal, H. Lachgar, N. Mahutte. Montreal
Fertility Centre, Montreal, QC, Canada;

FertilitySterilty

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Endoscope-Assisted Revision Surgery after Lumbar Fusion with Pedicle Screw Fixation: Hope for Failed Back Surgery Patients

A groundbreaking study has revealed new possibilities for patients suffering from failed back surgery syndrome, offering hope through minimally invasive endoscopic revision procedures. The research, published in Neurology India, demonstrates how this endoscopic technique can help patients who continue to experience pain after initial spine fusion surgery.

The study examined 231 endoscopic spine procedures performed between January 2021 and October 2022. While 23 patients underwent endoscopic revision surgery, researchers focused on three specific cases where patients experienced recurring nerve pain following lumbar fusion with pedicle screw fixation. The surgical team utilized two minimally invasive approaches: Percutaneous Endoscopic Lumbar Discectomy (PELD) and Unilateral Biportal Endoscopy (UBE).

“Traditional revision surgery often requires extensive tissue dissection, leading to longer recovery times and increased risk of complications,” explain the authors, who specialize in minimally invasive techniques. “This endoscopic approach represents a significant advancement in our field.”

The results were encouraging, with all three patients showing marked improvement after surgery. Pain scores decreased significantly, and spinal cord function improved according to standardized measurements. Notably, there were no complications during or after the procedures.

The technique proves particularly relevant for Indian healthcare settings, where cost-effectiveness and reduced hospital stays are crucial factors. The endoscopic approach offers several advantages over traditional revision surgery. It minimizes tissue damage, reduces post-operative pain, and lowers the risk of surgical site infections – a significant concern in our tropical climate. The smaller incisions also mean better cosmetic outcomes, which matters to many patients.

However, the study does have limitations. With only three patients and a relatively short follow-up period averaging less than a month, more research is needed. Two patients required additional interventions during follow-up, suggesting that patient selection criteria need careful consideration.

The technique could be particularly valuable in India, where we’re seeing an increasing number of spine surgeries, especially among our aging population. As more surgeons gain expertise in this approach, it could become a standard option for managing post-fusion complications.

This research marks an important step forward in spine surgery, potentially offering a safer, more effective solution for patients who thought they had run out of options. As more data becomes available and surgical expertise grows, this technique could transform how we approach failed back surgery syndrome in India.

Reference

Zhang, Jia-xuan; Ke, Zhen-yong; Zhong, Dian; Liu, Yang; Wang, Li-yuan; Wang, Yang. Endoscope-Assisted Revision Surgery after Lumbar Fusion with Pedicle Screw Fixation: A Case Series and Literature Review. Neurology India 72(5):p 988-996, Sep–Oct 2024. | DOI: 10.4103/neurol-india.Neurol-India-D-23-00115

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Central quadriceps tendon graft effective for ACL reconstruction with excellent functional outcomes: study

Anterior cruciate ligament (ACL) injuries are common, particularly among athletes, and often result in knee instability and decreased functionality. Arthroscopic ACL reconstruction is the standard treatment, typically using a patellar tendon bone graft (PTBG) or hamstring tendon graft (HTG). The central quadriceps tendon graft (QTG) has been proposed as a superior alternative due to its structural properties.

Ambareesh P et al conducted a study involving patients undergoing ACL reconstruction using the central quadriceps tendon graft. Functional outcomes were assessed using the Tegner Lysholm knee score at preoperative and postoperative intervals of two weeks, three months, and six months. Statistical analysis compared these scores over time.

The study was conducted at Vydehi institute of medical sciences and research centre, Bengaluru, Karnataka. It has been published in Cureus journal.

Key findings of the study were:

• In the study, 62.5% were in the age group <30 years, 25.0% were in the age group 31 to 40 years, and 12.5% were in the age group >40 years.

• The most common mode of injury was sports injury and road traffic accidents (RTA) accounting for 46.9% of the subjects, while only 6.2% of the subjects reported falling from height.

• Among the subjects, 90.6% were male and 9.4% were female.

• Right-side injuries were more prevalent (65.6%).

• The mean time from injury to surgery was 9.37 months.

• The mean graft size was 8.75 mm, and the mean tourniquet time was 105.94 minutes.

• Preoperative tests showed positive results for anterior drawer, Lachman, and pivot shift tests in most patients, which were negative postoperatively.

• Significant improvements in knee flexion and Lysholm knee scores were observed.

• Preoperative knee flexion ranged from 0-100° to 0-120°, improving to 0-120° to 0-130° six months postoperatively. The mean Lysholm knee score improved from 47.06 preoperatively to 93.16 at six months.

• Excellent outcomes were seen in 78.1% of the patients, with 21.9% achieving good outcomes.

The authors concluded that – “The central quadriceps tendon graft is an effective option for ACL reconstruction, offering excellent functional outcomes and low complication rates. It shows promise as a better alternative to traditional graft types, although further research is necessary to confirm these findings.”

Further reading:

Parameshwar A, Kumar L, Donthi S R, et al. (July 25, 2024) Analysis of the Functional Outcome of Arthroscopic Anterior Cruciate Ligament Reconstruction Using the Central Quadriceps Tendon Graft.

Cureus 16(7): e65351. doi:10.7759/cureus.65351

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Long term outcomes of mandibular coronectomy satisfactory when enamel is completely removed, suggests study

A study published in the Journal of Cranio-Maxillofacial Surgery suggests that the long-term outcomes of mandibular coronectomy are satisfactory and successful when enamel is completely removed.

This study aimed to analyze post-coronectomy complications, chronological root survival rate (success rate) using Kaplan–Meier analysis, and postoperative radiographic signs for root extraction. A total of 555 mandibular third molar coronectomies were clinically and radiologically evaluated (mean follow-up period, 27.2 months; range, 1 month to 10.5 years). Complications were observed in 22 (4.0%) cases. Temporary inferior alveolar nerve damage was observed in one (0.2%) case, and 21 (3.8%) retained roots required extraction between 1 and 64 months after coronectomy due to dry socket (two cases, 0.4%), primary non-wound closure (10 cases, 1.8%), secondary root exposure (seven cases, 1.3%), and submucosal root eruption (two cases, 0.4%). Residual enamel after coronectomy was more significantly found on 13 (61.9%) of 21 extracted roots than on 30 (5.6%) of 534 surviving roots. Kaplan–Meier analysis revealed an overall survival rate of 93.8% at 5 years and 92.2% at 10 years. The 5-year survival rates differed significantly (p < 0.001) between the enamel-free (97.0%) and residual enamel-attached (58.3%) roots. The Cox proportional hazards model showed a hazard ratio of 20.87 (95% confidence interval, 8.58–50.72). The long-term outcomes of coronectomy were satisfactory, and a higher success rate is expected when the enamel is completely removed during coronectomy.

Reference:

Kenichi Kurita, Hidemichi Yuasa, Shinichi Taniguchi, Motonobu Achiwa, Mitsuo Goto, Eri Kubota, Atsushi Nakayama, Atsushi Abe. Residual enamel removal to improve outcomes of mandibular third molar coronectomy: A single-center retrospective cohort study,

Journal of Cranio-Maxillofacial Surgery. Volume 52, Issue 9, 2024, Pages 1042-1049, ISSN 1010-5182. https://doi.org/10.1016/j.jcms.2024.06.003.

(https://www.sciencedirect.com/science/article/pii/S1010518224001860)

Keywords:

Long term, outcomes, mandibular, coronectomy, satisfactory, successful, enamel, completely, removed, suggests, study, Journal of Cranio-Maxillofacial Surgery, Dental enamel, Complication, Migration, Mandibular third molar, Survival rate, Kenichi Kurita, Hidemichi Yuasa, Shinichi Taniguchi, Motonobu Achiwa, Mitsuo Goto, Eri Kubota, Atsushi Nakayama, Atsushi Abe

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NEET UG 2024: SC Junks Plea Seeking Review of Verdict Refusing to Order Re-Exam

New Delhi: The plea seeking a review of the Supreme Court‘s August 2 verdict where it had refused to allow a fresh NEET-UG 2024 examination has been dismissed by the apex Court.

While considering the review plea by one Kajal Kumari, the Apex Court bench comprising Chief Justice of India (CJI) D Y Chandrachud and Justices J B Pardiwala and Manoj Misra dismissed it after observing that there was no error in its verdict, PTI has reported.

“There is no error apparent on the face of the record. No case for review under Order XLVII Rule 1 of the Supreme Court Rules 2013 has been established. The review petition is, therefore, dismissed,” the top court bench observed in its October 22 order. Further, the top court bench also rejected the request for an open court hearing on the matter. 

Medical Dialogues had earlier reported that the Supreme Court bench on August 2 had dismissed the pleas seeking a re-test for the NEET-UG 2024 exam after holding that there was no sufficient material on its record to establish that there was a systemic leak or malpractice, compromising the integrity of the examination.

“…sufficient material is not on record at present which indicates a systemic leak or systemic malpractice of other forms. The material on record does not, at present, substantiate the allegation that there has been a widespread malpractice, which compromised the integrity of the exam. To the contrary, an assessment of the data shows there are no deviations which indicate that systemic cheating has taken place,” the top court bench had earlier held in its order.

Also Read: SC Junks Plea Challenging two Questions in NEET 2024

CJI Chandrachud, who had authored the verdict on behalf of the bench, observed at that stage the information did not show the question paper being disseminated widely through social media, or the internet, or the answers being communicated to students using sophisticated electronic means, which could prove difficult to trace.

The top court, however, was critical of the conduct of the NTA. It said while the various issues the court dealt with did not lead to the conclusion that the integrity of the NEET was vitiated at a systemic level, “the manner in which NTA organised the exam” in 2024 had given rise to “serious concerns”.

It said a body such as the NTA, which was entrusted with the immense responsibility of conducting highly important competitive exams, couldn’t afford a “misstep” or take an incorrect decision, amending it at a later stage.

The top court had, therefore, directed the NTA to ensure all concerns highlighted by the court in its judgment were addressed and requested the seven-member committee headed by the former ISRO chairman to be mindful of the same while making recommendations.

Back then, the Supreme Court had also expanded the remit of the Centre-appointed panel — headed by former Indian Space Research Organisation (ISRO) Chief K Radhakrishnan — constituted to review the functioning of the National Testing Agency (NTA), which holds the National Eligibility-cum-Entrance Test (Undergraduate) (NEET-UG), and recommend examination reforms.

As the remit of the panel had been expanded, the top court said the committee would submit its report on various measures to rectify deficiencies in the examination system.

Over 23 lakh students took the NEET-UG 2024 held on May 5 for admissions to MBBS, BDS, AYUSH and other related courses.

Also Read: No Systemic Breach in NEET 2024! says Supreme Court, Slams NTA for ‘Flip-flops’ in Exam

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CDSCO panel Approves AstraZeneca’s Protocol Amendment proposal for Datopotamab Deruxtecan study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca‘s protocol amendment proposal to study anticancer drug Datopotamab Deruxtecan (DATODXT, DS-106)

This came after the firm presented protocol amendment 3.0 version 4.0 dated 30 July 2024, protocol no. D926PC00001. This is a study of Dato-DXd Versus the Investigator’s choice chemotherapy in Patients with Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

Dato-DXd is a combination of a humanized anti-TROP2 antibody and a topoisomerase I inhibitor payload. The antibody binds to TROP2, a protein that’s overexpressed in tumors and associated with increased aggressiveness and metastasis. The payload is then released, which targets DNA topoisomerase I and inhibits DNA replication, resulting in tumor cell death.

Dato-DXd is being studied in clinical trials for multiple cancers, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and HR-positive, HER2-negative breast cancer.

At the recent SEC meeting for Oncology held on 23rd October 2024, the expert panel reviewed the protocol amendment 3.0 version 4.0 dated 30 July 2024 protocol no. D926PC00001.

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

Also Read: CDSCO panel approves Sanofi Healthcare’s protocol amendment proposal to study SAR441566

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Abbott Gets CDSCO Panel Nod To Manufacture, Market Clarithromycin ER Tablets 1000 mg

New Delhi: Pharmaceutical major Abbott has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market clarithromycin extended-release (ER) tablets 1000 mg.

However, this approval is subject to the condition that the firm should conduct the Phase IV clinical trial.

This came after the drug maker Abbott presented the justification for the Phase III clinical trial waiver along with the bioequivalence (BE) data before the committee.

Clarithromycin is a macrolide antibiotic used for the treatment of a wide variety of bacterial infections, such as acute otitis, pharyngitis, tonsillitis, respiratory tract infections, uncomplicated skin infections, and helicobacter pylori infections.

Clarithromycin is first metabolized to 14-OH clarithromycin, which is active and works synergistically with its parent compound. Like other macrolides, it then penetrates bacteria cell walls and reversibly binds to domain V of the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome, blocking translocation of aminoacyl transfer RNA and polypeptide synthesis. Clarithromycin also inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein, an energy-dependent drug efflux pump.

At the recent SEC meeting for antimicrobials and antivirals held on October 24, 2024, the expert panel reviewed the justification for the Phase III clinical trial waiver along with BE data presented by drug maker Abbott.

After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of Clarithromycin extended-release tablets, 1000 mg, subject to the condition that the firm shall conduct a Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit a Phase IV clinical trial protocol within 3 months from the date of approval to CDSCO for further review by the committee.

Also Read: CDSCO Panel Approves Pfizer Protocol Amendment proposal to study anti-cancer drug Elranatamab

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Health Bulletin 07/ November/ 2024

Here are the top health news for the day:


Cardiologist contemplates quitting after mob attack amid rising violence against doctors

A recent X (formerly Twitter) post by a senior cardiologist went viral as he narrated how he was attacked by a mob of 20 to 30 people after providing all-day long treatment to a patient, who ultimately passed away.

It has been alleged that when the doctor reached out to the police, the response was “pathetic” and the Inspector of Police at Avalahalli Police Station allegedly pressurised the doctor to delete the post and not to register an FIR!

For more information, click on the link below:
Medical council summons doctor over YouTuber cutting newborn’s umbilical cord at Rainbow Hospital
In the latest update regarding the Rainbow Hospital controversy, where a YouTuber entered the operation theatre of a private hospital and cut his newborn’s umbilical cord, the Tamil Nadu Medical Council (TNMC) has decided to summon the doctor involved in the case, TNIE has reported.

The officials at the State Medical Council informed the Daily that they sought an explanation from the gynecologist and obstetrician who conducted the caesarean. Action from TNMC comes after they received a complaint from the Directorate of Medical and Rural Health Services (DMS) about the incident.

For more information, click on the link below:


Patient dies after 24-hour search for bed as 3 Kolkata government hospitals deny treatment

In a tragic incident, a 48-year-old man passed away after allegedly being denied treatment at three government medical college hospitals in Kolkata. The patient’s family reportedly spent 24 hours trying to secure a hospital bed.

The incident occurred on Tuesday when Haldar, a driver by profession was bleeding from his nose and mouth, and was brought to the hospital by his family in search of medical assistance.

For more information, click on the link below:

SC directs NMC to issue new guidelines for admitting PwD candidates to MBBS courses
In a significant ruling, the Supreme Court recently stressed the importance of creating an inclusive atmosphere for persons with disabilities seeking to pursue medical education, noting it to be a “vital component of quality healthcare”.

Highlighting that Disability Assessment Boards must comply with the rule of law principles by injecting transparency, fairness and consistency in their approach, the Apex Court bench comprising Chief Justice of India D.Y Chandrachud and Justices J B Pardiwala and Manoj Misra directed the National Medical Commission (NMC) to issue fresh guidelines for admitting persons with disabilities into medical courses.

For more information, click on the link below:

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