Preconception stress in women undergoing fertility treatment tied to higher blood sugar during pregnancy

USA: A new study in the Journal of the Endocrine Society showed that maternal stress during preconception was associated with higher blood glucose levels, especially among women using intrauterine insemination to conceive and women of higher socioeconomic status.

Stress during pregnancy is known to influence health outcomes, but the study from Mass General Brigham researchers suggests that stress levels before pregnancy are also important to evaluate. Investigators at Massachusetts General Hospital and Brigham and Women’s Hospital analyzed the link between self-reported stress immediately before conception among women seeking fertility care and blood glucose levels, a marker of heart health. 

“Stress prevalence has increased over the years, particularly for couples who are not able to conceive naturally,” said corresponding author Lidia Mínguez-Alarcón, PhD, MPH, Bpharm, a reproductive epidemiologist in the Brigham’s Channing Division of Network Medicine and co-investigator of the Environment and Reproductive Health (EARTH) study. “We wanted to evaluate how this stress affects health during pregnancy, which can affect both the mother and child in the long term.”

Mínguez-Alarcón and colleagues analyzed data from the EARTH study conducted at the Massachusetts General Hospital Fertility Center from 2004 to 2019 for 398 women between 18 and 45 years of age. The women self-reported preconception-perceived stress at study entry. Additional clinical characteristics and sociodemographic information, including family and medical history, consumer products use and smoking history, were either collected by the study staff through medical records or questionnaires.

Women had a median age of 35 years at study entry, and most were of white ethnic background (83 percent), reported never smoking (78 percent), and were at least college educated (64 percent). Three hundred of the women conceived using medically assisted technologies like intrauterine insemination (IUI) or in vitro fertilization (IVF). During IUI, sperm is injected directly into the uterus while IVF is a multi-step technology that involves retrieving an egg for fertilization in a lab before transfer back to the uterus. Glucose testing was done at a median of 26 weeks into pregnancy and taken one hour after the women drank a 50 gram glucose solution. A blood sugar that was equal to or less than 140 mg/dL was considered normal.

Researchers found that blood sugar levels, a measure of cardiovascular health, were abnormally high in 82 of the women involved. Previous studies have shown that women with a history of gestational diabetes (GD) during pregnancy are at increased risk of developing type 2 diabetes as well as cardiovascular problems later in life, including heart artery calcification.

The team found that women who experienced higher preconception stress had higher mean glucose levels. In addition, women who conceived through IUI had both higher stress and blood sugar levels than those who conceived through IVF. The study also found that women of higher socioeconomic status had higher levels of preconception stress and blood glucose levels during their pregnancy. Median family income was used to measure socioeconomic status.

“Professional women with higher incomes and attained education levels may be employed in demanding, time-intensive jobs and are often also responsible for balancing demands in the workplace with household duties and childcare,” Mínguez-Alarcón said. “It has previously been shown that women with a higher education level experience greater levels of job stress. Given that education level is positively associated with salary, this explanation may apply to women with higher incomes as well.”

Still, findings are limited since the study comprises a group of mostly white women of high socioeconomic status seeking fertility care. Self-reporting perceived stress may also result in participant bias. Future research can investigate additional variables like sleep quality or neighborhood safety as well as the effect of preconception stress on the baby’s health.

“Our results are of public health importance given the increasing rates of stress over the years and its effect on cardiovascular health,” Mínguez-Alarcón said. “Women can try to lower their stress levels through a variety of strategies like being more active, avoiding alcohol and drugs, eating healthy and avoiding isolation. Given the scarce literature in this field, our study has the potential to start important discussions.” 

Reference:

Lidia Mínguez-Alarcón, Olivia Chagnon, Aya Tanaka, Paige L Williams, Tamarra James-Todd, Jennifer B Ford, Irene Souter, Kathryn M Rexrode, Russ Hauser, Jorge E Chavarro, Preconception Stress and Pregnancy Serum Glucose Levels Among Women Attending a Fertility Center, Journal of the Endocrine Society, Volume 8, Issue 1, January 2024, bvad152, https://doi.org/10.1210/jendso/bvad152.

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Topical emollient improves xerosis and QoL in atopic dermatitis

Use of topical emollient alone can improve xerosis and quality of life in patients with atopic dermatitis suggests a new study published in the Journal of Drugs in Dermatology.

Repairing the epidermal barrier is critically important in atopic dermatitis (AD), but the effect of moisturizer on quality of life (QOL) is not well characterized.

A study was done to assess whether the use of a moisturizer improves QOL in atopic patients with xerosis.

Thirty-five (35) adults with xerosis and AD received a moisturizer designed for AD to apply daily for three months. Adherence was assessed with electronic monitors. Quality of life (QOL) was assessed with the Dermatology Life Quality Index (DLQI) at baseline and follow-up.

Results: Mean adherence to the moisturizer was 46%. Dryness improved from 1.9 at baseline to 1.4 at follow-up (P=0.02). DLQI improved from 3.3 at baseline to 1.5 at 3 months (P=0.005). The “feeling self-conscious or embarrassed due to their skin condition” DLQI item improved from 0.79 at baseline to 0.14 at 3 months (P=0.0009).

Moisturizers are the foundation of AD treatment. Even non-medicated topical emollients can improve QOL in patients with AD.

Reference:

Katherine A. Kelly BSa, Madison K. Cook BSa, Rohan Singh BSa, Patrick O. Perche BSa, Esther A. Balogh MDa, Irma M. Richardson MHAa, Steven R. Feldman MD PhDa. Topical Moisturizer Use Meaningfully Reduces Disease Severity in Atopic Patients With Xerosis. Journal of Drugs in dermatology. December 2023 | Volume 22 | Issue 12 | e51 | Copyright © December 2023

Keywords:

Use, topical, emollient, alone, can, improve, xerosis, quality of life, patients, atopic dermatitis, Katherine A. Kelly BSa, Madison K. Cook BSa, Rohan Singh BSa, Patrick O. Perche BSa, Esther A. Balogh

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Low-dose quadruple therapy promising for hypertension management

The mixed-methods process evaluation of the Quadruple Ultra‐Low‐Dose Treatment for Hypertension USA (QUARTET USA) clinical trial examines the perceptions of patients and healthcare professionals on the use of low-dose quadruple therapy (LDQT) as a novel approach for managing hypertension.

A study published in the Journal of the American Heart Association, JAHA, has concluded that LDQT is well-accepted by patients and healthcare professionals for managing hypertension due to its improved blood pressure control and safety. To achieve LDQT’s widespread adoption, stepped-care combinations, treatment protocols, and cost barriers, including insurance coverage and transportation, must be addressed.

A survey was conducted on all 62 patients enrolled in the QUARTET USA trial, and a subsample of 13 patients and 11 healthcare professionals were interviewed. At enrollment, 68% of participants (mean age 51.7 years) reported that their health relied on blood pressure medications, and 48% worried about these medicines.

At the end of the trial, 80% of patients were satisfied with LDQT, 96% felt the benefits of taking LDQT outweighed the drawbacks, and 96% found LDQT to be convenient. Both patients and healthcare professionals found LDQT acceptable because it reduced patients’ pill burden and improved medication adherence. Healthcare professionals noted that a limitation of LDQT was the inability to titrate doses. To promote LDQT implementation, steps such as introducing stepped-care combinations and treatment protocols, including it in clinical practice guidelines, and eliminating patient cost barriers can be taken.

Our study is the first to investigate the effectiveness of low-dose quadruple therapy on hypertension control rates in an urban federally qualified health centre network. Treatment satisfaction was high. Scalable interventions are needed to address inequitable blood pressure control rates across diverse contexts. If clinical trial evidence supports the efficacy of low-dose quadruple therapy and patient cost barriers are eliminated, health care professionals would prescribe it, they concluded further.

The major strength of this study is the inclusion of a diverse patient population, they said.

Reference:

Olutobi A. Sanuade et al. Process Evaluation of a Double‐Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra‐Low‐Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA). Journal of the American Heart Association. 2024;13:e032236

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AIIMS Raipur Releases guidelines for PhD Admissions, details

Raipur: All India Institute of Medical Sciences (AIIMS Raipur) has released the guidelines for PhD admission to be followed.

The PhD degree awarded by the Institute shall be designated as Doctor of Philosophy of the All India Institute of Medical Sciences, Raipur. The certificate shall not indicate the subject or specialty PhD Courses at AIIMS Raipur are full-time courses.

Admission to PhD courses conducted at the Institute is made once a year on merit, on an India basis by holding an entrance examination by the Institute. All vacant seats shall be advertised in national dailies in the month of February/March for the July Session which shall commence approximately from 1st July each year, the last date of joining being 31st August.

Advertisement of number of seats –

Every department should send a request regarding the number of seats to be advertised in each session. The faculty member should also indicate the number of PhD students already enrolled under him/her.

The department should also submit a list of all PhD candidates registered in the department along with the list of Chief Guide and also specify the number of candidates registered under a Chief Guide. This shall also include In-House candidates, if any.

All this information and the number of seats available in various departments will be available on the AIIMS, Raipur website.

In the departments where the full strength of students are getting admitted in postgraduate courses (MD/MS/DM/M.Ch/MPT/MPH), each individual faculty member shall be permitted to be the Chief Guide of maximum 2 PhD students at any given point of time, while in those departments where the full strength of students are not getting admitted in postgraduate courses, each individual faculty member shall be permitted to be the Chief guide of maximum 5 PhD students.

One seat shall be advertised for the In-house Candidates per department, in addition to those advertised for External candidates.

General Criteria –

Candidates holding Medical Qualifications –

Must possess a Medical degree or a Postgraduate degree in the subject concerned or equivalent qualification included in any one of the Schedules to the Indian Medical Council Act, 1956 (102 of 1956) and National Medical Commission Act, 2019 or recognized by the respective regulatory bodies. and candidates who have obtained MBBS/BDS/MD/MS/MDS degrees are eligible to apply.

Candidates holding non-medical qualifications –

1. Candidates who have obtained a Master’s Degree in any subject recognized by UGC colleges/institutes recognized by the respective regulatory bodies/UGC are eligible.

2. Candidates holding an M.Sc. degree in the Nursing speciality will also be eligible for PhD admission.

3. Candidate possessing Masters’s Degree through distance learning course shall not be eligible.

Minimum aggregate marks to be obtained in the Qualifying Degree Examination –

Candidates who have obtained their qualifying degree scoring at least 55% marks in aggregate shall be eligible to apply for the PhD entrance examination.

Criteria for candidates already holding a PhD Degree –

Candidates who already possess a PhD Degree awarded / successfully qualified in any subject by AIIMS, Raipur / any other recognized academic institution, shall not be eligible to apply for another additional PhD degree at AIIMS, Raipur

Department-specific eligibility qualifications are enclosed in the notice below.

Criteria for Financial Support –

Candidates who are holding their own fellowship from NET/CSIR/ICMR/DBT/DST/UGC as JRF etc. to undergo PhD programme. An attested copy of the result must be attached. If the candidate fails to produce proof of his/her eligibility as per the above qualification before one week of the entrance examination, his/her candidature will not be considered and the entire responsibility for the same will lie on the candidate.

Availability of AIIMS stipend will be subject to rules of the institute –

1. Proposed: Rs.3 1,000/- per month for the first three years and then 15,000/- per month for the next two years and subject to non-availability of other funding resources. No stipend will be given beyond 5 years.

2. Subject to approval of progress by the Doctoral Committee.

3. Can be used as a stop-gap between fellowships from funding agencies.

4. Cannot be availed once thesis writing permission is granted by the Doctoral Committee / if an extension is provided beyond the stipulated period.

Eligibility criteria for admission of in-service candidates –

The program among in-house candidates is for faculty members and non-teaching technical staff only. It will not be open to senior residents.

Candidates from AIIMS Raipur –

1. Members of faculty and non-teaching technical staff can apply for registration to PhD course as in-service candidates. He/She will be exempted from appearing in the entrance examination.

2. The individual should be a regular employee of the institute and should have rendered a minimum of two years of continuous service at the institute.

3. The individual should have a minimum of 10 years of active service left in the institute at the time of application.

4. The medical faculty member should have at least 3 original research publications in Indexed journals (not case reports) during the last three years immediately preceding the date of his/her application either as a first author or as a corresponding author in peer-reviewed journals.

5. The candidate will be considered as an in-service candidate provided that the Head of the Department should certify that the work of the department will not suffer and no additional staff will be asked for.

6. The candidate seeking admission under this category will have to identify a faculty member in the same department (senior to the candidate) who is willing to be the candidate’s chief guide. The candidate should submit a letter of acceptance/undertaking from the concerned faculty member in this regard.

7. A maximum of 25% of In-House candidates at a given time should be registered as PhD candidates in a particular department.

8. The candidate seeking admission under this category will only be registered for PhD in the same department in which he/she is working.

9. These guidelines will not be applicable to other staff members employed under various research schemes which are on a tenure basis as they are not AIIMS permanent employees.

10. The faculty members who have registered himself/herself will not be eligible to guide / co-guide any other PhD candidate in the Institute till he/she completes the PhD However; he/she can continue to be a guide/co-guide for existing and new MD/MS/MDS/MPT/DM/MCh./MSc candidates.

11. If the faculty member and permanent scientist registering for a PhD is already a Chief guide to other PhD candidates, he/she should surrender the guideship to the co-guide before taking up the PhD registration for himself/herself.

12. The candidate seeking admission under this category should send a brief write-up (approx 1000 words) of the proposed project including the statement of purpose with feasibility and applicability during application for the course.

13. The candidate should also give a write-up on how his obtaining the said degree shall provide immediate and long term benefit to the candidate, department, and Institute.

Also Read:Bond Service Allotment: DMER Maharashtra Invites Online Applications From PG Degree Holders Winter 2023 Batch, details

Deputed /sponsored candidates from other institutions –

Regarding in-service candidates on deputation at AIIMS, Raipur, the candidates will be eligible to apply and will be considered on a case-to-case basis as per relevant criteria with prior permission from the Dean (Academics).

Candidate applying for admission as a sponsored/deputed candidate is required to furnish the following certificates with his/her application from his/her employer for admission to the course –

1. That the candidate concerned is an employee of the deputing/sponsoring authority and should produce a sponsorship certificate as outlined below.

2. That no financial implications in the form of emoluments/ stipend etc. will devolve upon AIIMS, Raipur during the entire period of his/her course. Such payment will be the responsibility of the sponsoring authority.

Deputation/Sponsorship of any candidate by private hospitals, institutes or nursing homes is not accepted. The sponsoring Institute should not nominate more than one candidate for a speciality. Sponsorship/deputation of candidates will be accepted only from the following –

Candidates who are permanent employees of any Central/State Government/Armed Forces or the Public Sector Undertaking/Autonomous Body can be sponsored by the respective Government/Defence Authorities or the Competent Authorities of the PSU/Autonomous Body.

Public sector colleges affiliated to universities and recognized by the MCI/UGC. In the case of a candidate appointed/sponsored by the Govt. Medical College affiliated to Universities and recognized by the Medical Council of India, a deputation/sponsorship certificate signed by the Principal of the Medical College concerned only shall be accepted.

All eligible “sponsored” candidates will be called by the Institute for an entrance test.

Seats as shown in the prospectus are available for “sponsored” candidates. Sponsored candidates will be designated as “trainees”.

The subject for which the candidate is being sponsored should be clearly specified in the sponsorship form by the sponsoring authority. The candidate can be sponsored for only one subject. The applications of candidates sponsored for more than one subject will not be considered.

No “Sponsored” candidate will be paid any emoluments by the [institute during the training period. Such payments will be the responsibility of the sponsoring authority (i.e. Central/State Government or defense authorities).

Sponsored candidates must submit/send sponsorship certificates in original from their employers in the given format along with the application form to the Assistant Controller (Examinations), AIIMS, Tatibandh, Raipur – 492099, Chhattisgarh. Those who fail to do so should submit it before the date of issue of Admit Cards as mentioned under “AT A GLANCE” in the Prospectus failing which their candidature will be canceled.

Eligibility criteria for admission of Foreign Nationals/Overseas Citizen Of India (OCI) –

Foreign nationals must fill in the prescribed online application form indicating the choice of subject (only one subject) for admission to Postgraduate courses leading to the award of a PhD Programme degree.

The foreign nationals must send their Registration Form of Online application through the Diplomatic Channel. They are also required to appear in the Competitive Entrance Examination along with other candidates. An ‘Advance Copy’ is to be submitted at AIIMS, Raipur before the last date of online registration. However, the application of all such candidates will be processed only after receipt of the same through the Diplomatic Channel.

The foreign nationals will be considered against the seats advertised under the “Sponsored” category for PhD Programme. Candidates with medical degrees should be registered with MCI before they can join the said course if they are selected for the same.

Seats are not reserved in any discipline for foreign nationals (except the bilateral agreement between the Government of India and any other nation).

Nominations/No objection for the candidate should reach the Examination Section before the date of issue of the Admit Card. In case of non-receipt of the nominations/clearance/no objection from the concerned Ministry by the due date, their candidature will not be considered.

No emoluments will be paid by AIIMS, Raipur to the Foreign National candidates.

Overseas Citizens of India (OCI): OCI registered under Section 7A of the Citizenship Act 1955 are also eligible to appear in PG courses and all terms and conditions applicable for Indian Nationals will be applicable to the candidates. The candidate will submit proof of Registration as OCI under Section 7 A of Citizenship Act 1 95 5 to be eligible to appear for this test.

The guide will have the option to accept or not to accept the candidate, who opts to do PhD under that particular faculty member. The candidate may opt for only a specific faculty member.

Duties of PhD student –

Duties of PhD Students joining as External Candidates: It must be noted that the primary duty of the student in the department is to pursue his/her thesis work only, as a full-time candidate for fulfillment of the objectives of the degree requirement. However, as the student needs to have an overall idea of the functioning of the department, the Head of the Department at his/her discretion can assign the student different departmental / emergency duties on rotation.

Duties of PhD Students joining as In-house Candidates: It must be noted that the primary duty of the student in the department is to work as per his/her service conditions of appointment as faculty of AIIMS, Raipur. The rest of the time can be dedicated to research work towards fulfilling the objectives of PhD thesis work. However, a balance needs to be maintained between the dual responsibilities so that the quality and scope of PhD work remain up to the standards demanded by the Institute of National Importance (INI). Towards this end, the PhD guide can discuss with the Head of the Department of the PhD student to decide the modalities under exceptional situations when the responsibilities of departmental work and PhD research work overlap so that the quality and scope of PhD work are not compromised.

Duration of the course –

The duration of the course i.e. the period of registration shall be the time from the date of registration to the submission of the thesis. This shall be followed by Post-submission evaluation and award of degree. The minimum period of registration for all the candidates who are registered for a PhD shall be three years, i.e., the thesis cannot be submitted before three years. The maximum period of registration shall not exceed five years. Extension beyond the period of 5 years can be given under exceptional circumstances for a maximum period of 6 months on the recommendation of the Doctoral Committee and final approval by the Dean (Academics)/Director.

Method of selection –

Selection for PhD registration will be through a two-stage performance evaluation through a common entrance test in Medical, Nursing and Allied Health Sciences. However, an In-house candidate shall not appear in the common entrance examination.

Entrance examination –

Centre for Examination: Examination will be conducted (CBT) modes.

Scheme of Examination – MCQ Questions:90, Max. Marks:90

Performance Evaluation Selection for PhD registration will be through a two-stage performance evaluation as under –

Stage I: 40 Marks (40 MCQs of I Mark each): Aptitude-related MCQs covering English (Written and verbal skills), Biostatistics, Research Methodology, etc.

Stage Il: 50 Marks (50 MCQs of I Mark each): Subject-related theory-based Multiple Choice Questions (MCQs) mainly explore broad-based basic scientific knowledge and particularly analytical aptitude for research in the subject.

Total Marks (Stage I + II): 90 (40+50)

Total Duration (Stage I + II): 90 Minutes

Candidates must score at least 45 marks in aggregate (stages I and II combined) to be eligible for selection.

The Special Weightage of 10 marks will be added to the total score of Stages I and those who fulfill the following criteria –

Any candidate who has qualified in any one of the following entrance tests in the last 2 years and possesses valid scores: Joint CSIR-UGC NET for JRF, [CMR-JRI’, ICMR-SRF, DBT-JRF, DBT-SRF, NBHM screening test, Graduate aptitude test (GATE), INSPIRE fellowship, UGC-JRF, UGC-SRF, CSIRJRF, CSIR-SRF, DST-JRF, DST-SRF or are sponsored/deputed candidates.

Joining –

Selected candidates will be intimated through e-mail. Thereafter, it will be assumed that he/she does not intend to join the course and the seat will be offered to the next candidate on the waiting list unless a written request for up to 15 days extension is received by the competent authority who may permit an extension of joining for this additional 15 days based on merit of each case. In case the candidate fails to join by this date, it will be assumed that he/she does not intend to join the course and the seat will be offered to the next candidate on the waiting list.

The seat will ordinarily lapse for the respective session if any candidate fails to join by intimated date, as the case may be. No further correspondence will be entertained in this regard. Apart from in-house candidates, the PhD courses can be joined only as full-time courses after getting a relieving letter from the sponsoring agency.

Medical examination – 

Medical fitness will be a pre-condition for the registration of all candidates. The candidates will be medically examined by a Medical Board, constituted by the Institute, to determine their medical fitness.

Fee –

India citizen – Rs 4125 (3 years duration) The detailed fee structure is enclosed in the notice below.

Foreign Nationals / Self-financed nominees/candidates and similar designations of Indian Govt -US Dollar 75,0001- inclusive of all Items mentioned in (i) above for the entire course, to be paid in three equal installments of USD 25,0001- each with a maximum gap of 1 year between payment of each installment. Permission to write the thesis shall be subject to full payment of the fees.

To view the notice, click on the link below –

https://medicaldialogues.in/pdf_upload/65968fe92077cphd-course-229415.pdf

Also Read:ICMR Invites Application For PhD Programme At National Institute for Pathology, details

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For epilepsy, yoga may be good for your mind

For people with epilepsy, doing yoga may help reduce feelings of stigma about the disease along with reducing seizure frequency and anxiety, according to new research published in the November 8, 2023, online issue of Neurology®, the medical journal of the American Academy of Neurology.

“People with epilepsy often face stigma that can cause them to feel different than others due to their own health condition and that can have a significant impact on their quality of life,” said study author Manjari Tripathi, MD, DM, of All India Institute of Medical Sciences in New Delhi. “This stigma can affect a person’s life in many ways including treatment, emergency department visits and poor mental health. Our study showed that doing yoga can alleviate the burden of epilepsy and improve the overall quality of life by reducing this perceived stigma.”

For the study, researchers looked at people with epilepsy with an average age of 30 in India.

Researchers measured stigma based on participants’ answers to questions such as: “Do you feel other people discriminate against you?” “Do you feel you cannot contribute anything in society?” and “Do you feel different from other people?”

Researchers then identified 160 people who met the criteria for experiencing stigma. Participants had an average of one seizure per week and on average took at least two anti-seizure medications.

Researchers then randomly assigned participants to receive yoga therapy or sham yoga therapy. Yoga therapy included exercises in loosening muscles, breathing, meditation and positive affirmations. Sham yoga consisted of exercises that mimic the same yoga exercises, but participants were not given instructions on two key components of yoga believed to induce a relaxation response: slow and synchronized breathing, and attention to the body movements and sensations during practice.

Each group received seven supervised group sessions of 45 to 60 minutes over three months. Participants were also asked to practice sessions at home at least five times a week for 30 minutes. They tracked seizures and yoga sessions in a journal. After the three months of therapy, participants were followed for another three months.

Researchers found when compared to people who did sham yoga, people who did yoga were more likely to reduce their perceived stigma of the disease. People who did yoga had an average score of seven at the start of the study and an average score of four at the end of the study, while people who did sham yoga had an increase from an average score of six at the start of the study to an average score of seven at the end.

Researchers also found that people who did yoga were more than four times as likely to have more than a 50% reduction in their seizure frequency after six months than the people who did sham yoga.

In addition, people who did yoga were more than seven times more likely to no longer have seizures than those who did sham yoga.

There was also a significant decrease in anxiety symptoms for people who did yoga versus people who did not. They saw improvements in quality of life measures and mindfulness.

“These study findings elevate the need to consider alternative therapies and activities for people with epilepsy facing stigma,” said Tripathi. “Yoga may not only help reduce stigma, but also improve quality of life and mindfulness. Plus, yoga can be easily prerecorded and shared with patients online using minimal resources and costs.”

A limitation of the study was that participants self-reported their seizure frequency and they may not have remembered all the information accurately.

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Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Giredestrant for Breast Cancer

New Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical trial of the anti-cancer drug Giredestrant compared with Fulvestrant, Palbociclib, Ribociclib, Abemaciclib.

This came after the drug major Roche presented Phase III clinical trial protocol No. CO44657.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator’s choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Giredestrant, an investigational small molecule, is a full ER antagonist belonging to the selective estrogen receptor degrader class of therapeutics.

Giredestrant induces an inactive conformation to the ER LBD, as measured by displacement of co-activator peptides. In addition to its direct antagonist properties, the mechanism of action of giredestrant includes reducing levels of ER protein through proteasome-mediated degradation.

Fulvestrant is an estrogen receptor antagonist used to treat HR+ breast cancer that may also be HER2-.Fulvestrant is used in the management and treatment of advanced breast cancer. It is a selective estrogen receptor degrader. This activity outlines the indications, action, and contraindications for fulvestrant as a valuable agent in the treatment of advanced breast carcinoma.

Palbociclib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply.

Ribociclib is a type of cancer growth blocker. It targets the proteins cyclin-dependent kinase 4 and cyclin-dependent 6 (CDK 4 and CDK 6) in breast cancer cells. CDK 4 and CDK 6 are proteins that stimulate cancer cells to divide and grow. Ribociclib works by blocking these proteins.
Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the Phase III clinical trial protocol No. CO44657.

After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as presented by the firm.

Also Read:Justify Clinical Relevance of Higher Strength of Caroverine Capsules: CDSCO Panel Tells Lincoln Pharma

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Maternal depressive symptoms during pregnancy associated with slower fetal growth rate: JAMA

In a recent study published in the Journal of American Medical Association unveiled a significant association between maternal depressive symptoms and fetal growth during the critical rapid growth stage (CRGS) before delivery. This period is approximately from 30 to 37 gestational weeks and is crucial for the long-term health implications of the newborn.

The prospective birth cohort study spanned from January 2018 to December 2020 and involved 2676 mother-offspring dyads. Excluding the factors like severe pre-existing diseases and anomalies, the study focused on understanding the impact of maternal mental health on fetal growth parameters.

With the help of Edinburgh Postpartum Depression Scale (EPDS) to measure depressive symptoms at a median gestational week of 24, the research found that higher scores on the EPDS were correlated with a slower rate of fetal growth. This was evident in parameters such as biparietal diameter (BPD), femur length (FL), abdominal circumference (AC), and estimated fetal weight (EFW).

The results showed a notable correlation between decelerated fetal growth rate and a elevated maternal depressive symptoms. Specifically, a higher EPDS score was associated with a slower rate of growth across FL (β = −0.40), AC (β = −1.97), and EFW (β = −50.11). These associations were found to be stronger in female fetuses and those from families with better socioeconomic conditions.

This study found a previously underexplored facet of maternal mental health’s impact on fetal development, emphasizing the importance of early screening for depressive disorders in pregnant women. The findings imply that addressing maternal mental well-being might not only benefit the mother but also play a crucial role in ensuring optimal fetal growth and subsequent health outcomes.

Source:

Zhang, L., Li, P., Ge, Q., Sun, Z., Cai, J., Xiao, C., Yu, C., Nosarti, C., Liao, J., & Liu, Z. (2023). Maternal Prenatal Depressive Symptoms and Fetal Growth During the Critical Rapid Growth Stage. In JAMA Network Open (Vol. 6, Issue 12, p. e2346018). American Medical Association (AMA). https://doi.org/10.1001/jamanetworkopen.2023.46018

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Justify inter-subject variability in BE study data: CDSCO Panel Tells Alkem on anticancer drug Relugolix

New Delhi: Reviewing the bioequivalence (BE) study report of the anti-cancer drug Relugolix presented by the drug major Alkem Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the Justification regarding significant Inter subject variability in presented BE study data.

In addition, the expert panel suggested that Alkem Laboratories should submit published pharmacokinetic/pharmacodynamic (PK/PD) data and data on the ratio of serum to CSF concentration.

Furthermore, the committee stated that the firm should submit the minimum effective concentration in CSF required for the pharmacological action of the proposed drug.

This came after Alkem Laboratories presented the BE study report before the committee.

Relugolix is an oral GnRH receptor antagonist for androgen deprivation therapy in the treatment of advanced prostate cancer.

Relugolix is used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]) in adult men. Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

At the recent SEC meeting for Oncology and Hematology held on 21st and 22nd December 2023, the expert panel reviewed the BE study report presented by the Alkem Laboratories.

After detailed deliberation, the committee opined that the firm should submit the following before the committee for further consideration:

1. Justification/clarification regarding significant inter-subject variability in presented BE study data.

2. Published PK/PD data

3. Data on the ratio of serum to CSF concentration

4. Minimum effective concentration in CSF required for pharmacological action of the proposed drug.

Also Read: CDSCO Panel grants AstraZeneca’s Protocol Amendment Proposal for Sodium zirconium cyclosilicate

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78 Specialist Post Vacancies At UPSC: Apply Now

New Delhi: The Union Public Service Commission (UPSC) has invited online applications for the Specialist Grade III Post in the Department of Health & Family Welfare, Government of National Capital Territory of Delhi permanently in different dept.

UPSC is India’s premier central recruiting agency. It is responsible for appointments to and examinations for All India services and group A & group B of Central services.

UPSC Vacancy Details:

Total no. of Vacancies:- 78

The Vacancies are in Anaesthesiology, Biochemistry, Forensic Medicine, Microbiology, Pathology, and Plastic Surgery and Reconstructive Surgery.

Last Date of Application: 11th January 2024.

For more details about Qualifications, Age, Pay Allowance, and much more, click on the given link:

HOW TO APPLY?

i) Candidates must apply online through the website http://www.upsconline.nic.in. Applications received through any other mode would not be accepted and summarily rejected.

ii) Candidates must upload the documents/certificates in support of all the claims made by them in the application like, Date of Birth, Experience (preferably in prescribed format), Desirable Qualification(s) etc. or any other information, separately against each claim in pdf file in such a way that the file size does not exceed 1 MB for the respective aforesaid modules and 2 MB for the “UPLOAD OTHER DOCUMENT” module and is legible when a printout taken. For that purpose, the applicant may scan the documents/certificates in 200 dpi grey scale. Documents like Pay Slip, Resume, Appointment Letter, Relieving Letter, Un-signed Experience Certificate etc. must not be uploaded in the Document Upload Module:-

a) Matriculation/10th Standard or equivalent certificate indicating date of birth, or mark sheet of Matriculation/10th Standard or equivalent issued by Central/State Board indicating Date of Birth in support of claim of age. Where date of birth is not available in certificate/mark sheets, issued by concerned Educational Boards, School leaving certificate indicating Date of Birth (in case of Tamil Nadu& Kerala).

b) Degree/Diploma certificate as proof of educational qualification claimed. In the absence of Degree/Diploma certificate, provisional certificate along with mark sheets pertaining to all the academic years.

c) Order/ letter in respect of equivalent Educational Qualifications claimed, indicating the Authority (with number and date) under which it has been so treated, in respect of equivalent clause in Essential Qualifications, if a candidate is claiming a particular qualification as equivalent qualification as per the requirement of advertisement.

d) Certificate(s) in the prescribed proforma from the Head(s) of Organization(s)/Department(s) for the entire experience claimed, clearly mentioning the duration of employment (date, month & year) indicating the basic pay and consolidated pay. The certificate(s) should also mention the nature of duties performed/experience obtained in the post(s) with duration(s). Experience Certificate should be issued in prescribed format relevant to the post. Experience certificate not in prescribed proforma but containing all the details as mentioned above would be considered on merits by the Commission.

e) Caste certificate by candidate seeking reservation as SC/ ST/ OBC, in the prescribed proforma from the competent authority indicating clearly the candidate’s Caste, the Act/ Order under which the Caste is recognized as SC/ ST/ OBC and the village/ town the candidate is ordinarily a resident of.

f) A declaration in the prescribed format by candidate seeking reservation as OBC, that he/she does not belong to the creamy layer on the crucial date, in addition to the community certificate (OBC). Unless specified otherwise, the prescribed closing date for receipt of Online Recruitment Application for the post is to be treated as crucial date.

g) Certificate of Disability in prescribed proforma issued by the competent authority to Persons with Benchmark Disabilities (PwBD) eligible for appointment to the post on the basis of prescribed standards of Medical Fitness. The Competent Authority to issue Certificate of Disability shall be a Medical Board duly constituted by the Central or a State Government. The Central/ State Government may constitute Medical Board(s) consisting of at least three members out of which at least one shall be a specialist in the particular field for assessing Locomotor/ Cerebral / Visual / Hearing disability, as the case may be.

h) Documentary support for any other claim(s) made.

Note: If any document/ certificate furnished is in a language other than Hindi or English, a transcript of the same duly attested by a Gazetted officer or notary is to be uploaded.

Also Read:Walk In Interview At ESIC Medical College And Hospital Kalaburagi, Karnataka For Super Specialist Post, Apply Now

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CDSCO Panel Grants Novartis Protocol Amendment Proposal For Alpelisib

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis’ protocol amendment proposal for the phase III clinical trial of Alpelisib( BYL719) in combination with Nab-paclitaxel in patients with advanced triple-negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha(PIK3CA) mutation or Phosphate and Tension Homolog Protein (PTEN) loss without PIK3CA mutation.

This came after the drug major Novartis presented Protocol Amendment version 02 dated 14 March 2023, Protocol no. CBYL719H12301.

The above study is a phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple-negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation.

Alpelisib is indicated in combination with fulvestrant to treat postmenopausal women, and men, with advanced or metastatic breast cancer. This cancer must be hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and PIK3CA­ mutated. The cancer must be detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Alpelisib selectively inhibits PIK3 in the PI3K/AKT kinase (or protein kinase B) signaling pathway, thereby inhibiting the activation of the PI3K signaling pathway. This results in the inhibition of tumor cell growth and survival in susceptible tumor cell populations.

At the recent SEC meeting for Oncology and Hematology on 29th and 30th November 2023, the expert panel reviewed the Protocol Amendment proposal version 02 dated 14 March 2023, Protocol no. CBYL719H12301 presented by Novartis.

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

Also Read: Conduct Phase III CT: CDSCO Panel Tells Akum Pharmaceutical on Antidiabetic FDC

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