No Evidence of surgery! Consumer Court Exonerates Eye Hospital of medical negligence charges

Chandigarh: The State Consumer Disputes Redressal Commission (SCDRC), Punjab, recently exonerated a Pathankot-based Eye Hospital, accused of medical negligence during eye surgery, after noting that there was no evidence on record to prove that the surgery was performed.

The history of the case goes back to 2020 when the complainant suffered an eye injury at work and approached the treating hospital for medical treatment. It was submitted by the patient that the hospital got the injured left-eye-radio-graphed (x-rayed) and observed that a ‘Tiny radio-opacity noted in the left orbit seems some foreign particle’ and advised for surgery.

Post-surgery, the complainant visited the hospital the next day, was given an injection in his left eye and was asked to follow the treatment. Follow-up treatments were continued. However, the patient claimed that even though the hospital had assured that the left eye had recovered after removing the foreign particle, the condition of the left eye deteriorated due to an infection in the eye and the injury got worse so that he had to be operated again at a hospital in Amritsar. Due to the injury to the eye, the complainant allegedly could not do his professional duties. Filing the consumer complaint, he demanded Rs 20,00,000 as damages.

On the other hand, the treating hospital submitted that the complainant had approached them 48 hours after the eye injury and previously he received medical treatment from a local clinic. However, the eye continuously swelled with infection. They also submitted that there was no negligence on their part and prayed for the dismissal of the complaint. While considering the matter, the District Commission had dismissed the complaint. Challenging this, the complainant approached the State Consumer Court, Punjab.

The Commission noted that even though the Complainant argued that the surgery was performed on his left eye by the treating hospital, there was no evidence on record to prove it.

“As per the contentions of the appellant/complainant that surgery was performed on his left eye by the respondent/opposite party, if it is so, then it was his prime duty to produce some sufficient evidence on the record to prove that any such surgery was performed and he remained in the hospital as indoor patient but as observed, there is no evidence on the file to prove that any such treatment was given to the appellant/ complainant,” noted the Commission.

On the other hand, the Commission noted that the hospital alleged that the complainant’s eye was infected and filled with puss and blood, so it was not possible to perform any surgery. The hospital claimed that the complainant was given initial treatment with the medicines to follow.

Taking these arguments into consideration, the Commission observed,

“From the perusal of the record produced on record by the appellant /complainant, nothing is proved that the respondent/ opposite party performed the surgery upon the appellant/complainant due to which he lost his left eye. In lack of any proper evidence on behalf of the appellant/ complainant qua the allegations, as leveled, the respondent/ opposite party cannot be penalize for the act which they never committed.”

“The District Commission while deciding the complaint of the complainant has rightly observed that the opposite party-Hospital/ doctor has been viciously and unnecessarily accused by the appellant/complainant seemingly for an ulterior purpose,” the State Commission observed, while upholding the District Commission’s order.

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/punjab-scdrc-no-medical-negligence-262026.pdf

Also Read: No Medical Negligence in Administering Anaesthesia- Consumer Court relief to UP Hospital, Doctors

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Lipoxin A4 improves cardiac remodeling in diabetic heart disease patients: Study

The preclinical study, published in Cardiovascular Diabetology, found LXA4, which is known for its “calming agent” action in turning off the body’s inflammatory response and preventing chronic inflammation, could also serve as a potential new treatment for diabetes-induced heart disease.

Heart conditions like atherosclerosis, heart attacks and heart failure are the leading killers of people with diabetes, driving a growing global health crisis.

Senior author Dr Chengxue Helena Qin, from the Monash Institute of Pharmaceutical Sciences (MIPS), said chronic inflammation plays a key role in these heart problems, causing ongoing damage to the diabetic heart over time.

“We found that LXA4 could halve inflammation and scar formation, specifically in cases of heart disease induced by diabetes, as seen in the preclinical animal models,” Dr Qin said.

“With recent advancements in developing more ‘drug-like’ LXA4, our findings point to the potential of LXA4-based therapies as a promising new way to manage diabetic heart disease.”

Another co-author of the research, Senior Research Fellow at Monash’s Department of Diabetes, Dr Phillip Kantharidis said currently, heart inflammation in diabetic patients is treated the same way as that of other heart disease patients.

“This study opens up the possibility of more targeted and effective treatment possibilities for diabetic heart disease patients when combined with their usual blood sugar management medication,” Dr Kantharidis said.

The first author of the research, MIPS PhD candidate Ting Fu, said the team observed the beneficial effect of LXA4 on the immune system within the diabetic heart.

“We saw the molecule stimulate reparative macrophages-a type of white blood cell-within the diabetic heart,” Ms Fu said.

“These good macrophages reduced scar formation (due to chronic inflammation) in the heart and also helped to improve the overall function.”

As next steps, efforts to create a stable drug version based on the LXA4 molecule are in progress.

The researchers are also investigating the broader applicability of this study to a range of other inflammatory diseases and exploring other drug options to address different aspects of cardio-pulmonary diseases. 

Reference:

Fu, T., Mohan, M., Bose, M. et al. Lipoxin A4 improves cardiac remodeling and function in diabetes-associated cardiac dysfunction. Cardiovasc Diabetol 23, 413 (2024). https://doi.org/10.1186/s12933-024-02501-x

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Study Reveals Increased Risk of Hypoglycemia After Roux-en-Y Gastric Bypass Surgery in Non-Diabetic Patients

A recent study published in Obesity Surgery has highlighted a significant increase in the risk of hypoglycemia in patients who undergo Roux-en-Y gastric bypass (RYGB) surgery, even in those without a prior diagnosis of diabetes.

The propensity score-matched analysis, which compared outcomes in patients with obesity and no diabetes, found that RYGB surgery not only heightened the risk of low blood sugar levels in the short term but also posed a long-term risk for hypoglycemic events. The findings challenge the traditional view that hypoglycemia is mainly a concern for patients with preexisting diabetes.

“RYGB surgery significantly elevated the risk of hypoglycemia in obese patients, including those without diabetes, both in the short and long term. A recent study found that 18.7% of RYGB patients experienced hypoglycemia, compared to 3.8% in the control group (HR 4.3). Over the long term, RYGB patients continued to face a higher risk, with hazard ratios ranging from 5.37 at 1 week to 3.75 at 10 years,” the researchers reported.

Roux-en-Y gastric bypass, a widely performed weight loss surgery, is known to improve insulin sensitivity and reduce blood sugar levels in diabetic patients. However, the frequency and long-term risk of hypoglycemia after surgery in patients without diabetes remain uncertain. Therefore, the study aimed to examine the prevalence of hypoglycemia in patients with obesity and without diabetes following RYGB surgery.

For this purpose, the researchers conducted a retrospective cohort study using the TriNetX database. The study included 15,085 patients with obesity (BMI ≥ 30 kg/m²) who underwent RYGB surgery and 3,200,074 non-surgical controls, all of whom had no history of diabetes or use of GLP-1 receptor agonists. Propensity score matching was applied to balance baseline characteristics.

The primary outcome was the incidence of hypoglycemia, defined by ICD-10-CM codes or laboratory values (glucose ≤ 70 mg/dL). Cox regression analysis was used to calculate hazard ratios (HR).

The study led to the following findings:

  • In the overall study population, the risk of hypoglycemia was significantly higher in the RYGB group (18.70%) compared to the control group (3.80%), with a hazard ratio (HR) of 4.3.
  • After propensity score matching (n = 14,916 per group), the RYGB patients still showed a higher risk (18.70%) compared to the matched controls (5.0%), with a hazard ratio of 3.7.
  • Time-series analysis demonstrated consistently higher hypoglycemia risk in the RYGB group, with hazard ratios ranging from 5.37 at 1 week to 3.75 at 10 years post-surgery.
  • Subgroup analysis of RYGB patients who developed hypoglycemia showed a 30-day hospitalization rate of 21.3% and a mortality rate of 0.71%.

“While RYGB surgery remains a highly effective treatment for severe obesity, the increased risk of hypoglycemia must be carefully considered when making treatment decisions and planning post-operative care for patients with obesity but without diabetes,” the researchers wrote.

“Striking a balance between the benefits of weight loss and metabolic improvements and the potential risk of hypoglycemia is essential to optimize patient outcomes and ensure the long-term success of bariatric surgery,” they concluded.

Reference:

https://www.springermedizin.de/increased-risk-of-hypoglycemia-following-roux-en-y-gastric-bypas/50202276

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Higher Community water fluoridation coverage tied to significant lowering risk of developing caries: Study

Higher Community water fluoridation coverage tied to significantly lowering the risk of developing caries suggests a new study published in The Journal of the American Dental Association.

Caries is the most common chronic disease among children. In Pennsylvania, a comprehensive oral health Basic Screening Survey and assessment of the association between caries and community water fluoridation (CWF) among children have not been conducted. From 2021 through 2022, the first Basic Screening Survey was conducted among third-grade students in Pennsylvania. Oral health and demographic data were collected. CWF data were provided by the Pennsylvania Department of Environmental Protection. The relative risk of developing caries in association with CWF was assessed using the GENMOD procedure in SAS, Version 9.4 (SAS Institute) in this cross-sectional study. Results: Caries prevalence was 59.7% among 4,120 screened students. Participation in the free or reduced lunch program and CWF were each significantly associated with risk of developing caries after adjustment for age, sex, and race and ethnicity. The risk of developing caries was 33% higher among students who participated in the free or reduced lunch program than those who did not participate (relative risk, 1.33; 95% CI, 1.24 to 1.42). Students with the highest CWF coverage had a nearly 16% lower risk of developing caries than those without CWF coverage (relative risk, 0.84; 95% CI, 0.75 to 0.94). CWF was significantly associated with a reduced risk of developing caries. Efforts are needed to increase CWF coverage, along with promotion of oral health education and healthy dietary habits among Pennsylvania children.

Reference:

Yang J, Ma ZQ, Burroughs JE, Miller JM, McDaniel J, Hawkey H, Dupler KL, Hanley C, McHugh L. Cross-sectional study of association between caries and fluoridated water among third-grade students in Pennsylvania. J Am Dent Assoc. 2024 Aug;155(8):679-686. doi: 10.1016/j.adaj.2024.05.008. Epub 2024 Jun 21. PMID: 38904648.

Keywords:

Higher, Community, water, fluoridation, coverage, tied, significant, lowering, risk, developing, caries, study, The Journal of the American Dental Association, Yang J, Ma ZQ, Burroughs JE, Miller JM, McDaniel J, Hawkey H, Dupler KL, Hanley C

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CPAP Therapy Reduces Cardiometabolic Risk Factors in Sleep Apnea, New Meta-Analysis Shows

China: A new systematic review and meta-analysis has provided strong evidence that Continuous Positive Airway Pressure (CPAP) therapy can positively impact cardiometabolic risk factors (CMRFs) in patients with obstructive sleep apnea (OSA). The research, published in Respiratory Medicine Journal, sheds light on how this commonly used treatment for OSA may help reduce the risks of heart disease, diabetes, and other metabolic conditions.

“CPAP therapy resulted in reductions in blood pressure (BP), total cholesterol, triglycerides, and fasting blood glucose. However, it did not affect LDL-C, HDL-C, waist circumference, or BMI. Compliance with CPAP was essential for achieving these metabolic improvements, with the most significant benefits observed in younger, obese patients with OSA,” the researchers reported.

Obstructive sleep apnea is a condition where the airway becomes blocked during sleep, leading to breathing interruptions. It is commonly associated with a range of serious health problems, including hypertension, insulin resistance, and cardiovascular disease. CPAP therapy, which works by keeping the airway open with a continuous stream of air, has long been used to treat OSA. However, its effects on cardiometabolic health—specifically, its ability to reduce risk factors such as blood pressure, cholesterol levels, and blood sugar—have been less well understood.

To fill this knowledge gap, Yong Zhang, Department of Forensic Medicine, College of Basic Medical Sciences, Jilin University, Changchun, Jilin, China, and colleagues aimed to evaluate the impact of CPAP therapy on cardiometabolic risk factors in patients with obstructive sleep apnea.

For this purpose, the researchers conducted a comprehensive search of PubMed, Cochrane Library, Scopus, Web of Science, and Embase to identify randomized controlled trials up to December 2023. The quality of the included studies was assessed using the Cochrane Bias Risk Tool 2.0, and a meta-analysis was performed using Stata15.1 software. Effect sizes in the meta-analysis were reported as the weighted mean difference (WMD).

The study identified the following key findings:

  • A total of 52 studies involving 10,104 participants were analyzed.
  • CPAP therapy significantly reduced:
    • Systolic blood pressure (WMD: -2.04 mmHg)
    • Diastolic blood pressure (WMD: -1.40 mmHg)
    • Total cholesterol (WMD: -0.27 mmol/L)
    • Triglycerides (WMD: -0.02 mmol/L)
    • Fasting blood glucose (WMD: -0.15 mmol/L)
  • However, there were no significant changes in:
    • Low-density lipoprotein cholesterol (LDL-C)
    • High-density lipoprotein cholesterol (HDL-C)
    • Waist circumference
    • Body mass index (BMI) after CPAP treatment.

“This meta-analysis revealed that CPAP therapy effectively reduces specific cardiometabolic risk factors in patients with obstructive sleep apnea, providing valuable insights for cardiovascular disease prevention,” the researchers concluded.

Reference: https://www.resmedjournal.com/article/S0954-6111(24)00327-5/abstract

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DNB Post MBBS, Post Diploma admissions in Gujarat, Check fee structure

Gujarat- Director of Medical Education (DME) Gujarat has released the fee structure for candidates seeking admission to DNB Post MBBS and DNB Post Diploma courses.

As per the fee structure, a total of Rs 1.25 Lakh is the tuition fee per year for the Post MBBS DNB and post MBBS Diploma DNB Seats. A total of 10 seats are available in Post MBBS DNB and post MBBS Diploma DNB Seats. Of these, 6 seats are in post MBBS Diploma DNB and 4 seats are in Post MBBS DNB.

Below is the detailed fee structure-

Also Read: PG Ayurveda, Homeopathy 2024: DME Gujarat Extends 4th Online Stray Vacancy Round Registrations

POST MBBS DNB SEATS

S.NO

HOSPITAL NAME

SPECIALITY

NO.OF SEATS

RESERVATION CATEGORY

TUITION FEES PER YEAR

1

GMERS Medical College and General Hospital, Himmatnagar, Sabarkantha.

Anesthesia

1

UR

1.25 Lakh

2

GMERS Medical College and General Hospital, Dharpur, Patan.

General Medicine

1

OBC

1.25 Lakh

3

GMERS Medical College and General Hospital, Sola, Ahmedabad.

General Surgery

1

EWS

1.25 Lakh

4

GMERS Medical College and General Hospital, Vadnagar.

Pathology

1

ST

1.25 Lakh

TOTAL

4

POST MBBS DIPLOMA DNB SEATS

S.NO

HOSPITAL NAME

SPECIALITY

NO.OF SEATS

RESERVATION CATEGORY

TUITION FEES PER YEAR

1

GMERS Medical College and General Hospital, Junagadh.

Anesthesia

1

ST

1.25 Lakh

2

GMERS Medical College and General Hospital, Vadnagar.

Obstetrics and Gynaecology

1

EWS

1.25 Lakh

3

GMERS Medical College and General Hospital, Dharpur, Patan.

Obstetrics and Gynaecology

1

UR

1.25 Lakh

4

GMERS Medical College and General Hospital, Himmatnagar, Sabarkantha.

Obstetrics and Gynaecology

1

SC

1.25 Lakh

5

GMERS Medical College and General Hospital, Himmatnagar, Sabarkantha

Radio Diagnosis

1

UR

1.25 Lakh

6

GMERS Medical College and General Hospital, Dharpur, Patan.

Radio Diagnosis

1

OBC

1.25 Lakh

TOTAL

6

The Government of Gujarat had constituted the “Admission Committee for Professional Post Graduate Medical Educational Courses (ACPPGMEC)” to regulate the admission of candidates to the CPS Diploma courses. The mission assigned to this Committee is to carry out the counselling process fairly and transparently. The admission process is conducted by this Committee strictly based on the candidate’s merit. The Gujarat Government has also established the Admission Committee for Professional Post-Graduate Medical Educational Courses (ACPPGMEC) to regulate the admission of candidates to professional medical courses. 

To view the fee structure, click the link below

https://medicaldialogues.in/pdf_upload/fee-structure-262042.pdf

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Novartis Healthcare gets CDSCO Panel nod to study Iptacopan

New Delhi: The drug major Novartis Healthcare has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the extension part of the study to evaluate the long-term efficacy, safety, and tolerability of iptacopan (LNP023) in C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis.

This came after Novartis Healthcare presented phase IIIb clinical study protocol no. CLNP023B12001B, version 03 dated 25 July 2022. This is an An open-label, non-randomized extension study to evaluate the long-term efficacy, safety, and tolerability of iptacopan (LNP023) in C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis.

The firm also presented unblinded data for CLNP023B12301 APPEAR-C3G Core study.

Iptacopan is an oral drug that may be an effective treatment for idiopathic immune complex-membranoproliferative glomerulonephritis (IC-MPGN). Iptacopan is a complement factor B inhibitor that blocks the alternative complement pathway (AP). Iptacopan is a promising treatment for IC-MPGN because dysregulation of the AP is implicated in the disease’s pathophysiology.

IC-MPGN is a rare, fast-progressing kidney disease that can be idiopathic or secondary to other conditions. It’s characterized by glomerular deposits of immune complexes containing both Ig and complement proteins.

Dysregulation of the alternative complement pathway is implicated in the pathophysiology of IC-MPGN; and currently, there are no approved targeted treatments. Iptacopan is an oral, highly potent proximal complement inhibitor that specifically binds to factor B and inhibits the alternative pathway (AP).

At the recent SEC meeting for renal drugs, the expert panel reviewed phase IIIb clinical study protocol no. CLNP023B12001B, version 03 dated 25 July 2022.

After detailed deliberation, the committee recommended the grant of permission to conduct the extension part of the study as presented by the firm.

Also Read:Sun Pharma Laboratories Gets CDSCO Panel Nod To Manufacture Market Antipsychotic Lumateperone Capsule

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Conduct Phase III CT: CDSCO Panel Tells Zydus Healthcare on Glycopyrrolatem plus Indacaterol metered dose inhalation

New Delhi: Considering the bioequivalence study report presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm conduct the Phase III clinical trial of the fixed dose combination (FDC) pulmonary drug Glycopyrrolate plus Indacaterol Maleate metered dose inhalation.

This came after Zydus Healthcare presented a bioequivalence (BE) study report as well as justification for a Phase III clinical trial (CT) waiver before the committee.

Indacaterol and glycopyrrolate combination is used as long-term maintenance treatment of air flow blockage in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty breathing). Indacaterol and glycopyrrolate are long-acting bronchodilators.

Glycopyrronium, also known glycopyrrolate, is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications.

Glycopyrronium binds to muscarinic receptors in bronchial smooth muscle, preventing acetylcholine from binding and causing bronchoconstriction. Glycopyrronium preferentially binds to M3 receptors, which are primarily responsible for bronchoconstriction in COPD. Glycopyrronium can improve lung function, reduce the risk of exacerbations, and relieve breathlessness.

Indacaterol is an inhaled long-acting beta-2 adrenergic agonist used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.

Indacaterol works by stimulating adrenergic beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD. It is also long-acting due to its high affinity to the lipid raft domains in the airway membrane, so it slowly dissociates from the receptors. Indacaterol also has a high intrinsic efficacy, so it is also very rapid acting—onset of action occurs within 5 minutes.

At the recent SEC meeting for pulmonary, the expert panel reviewed the bioequivalence (BE) study report as well as justification for a Phase III clinical trial (CT) waiver presented by Zydus Healthcare.

After detailed deliberation, the committee considered the BE study report and opined that the firm needs to conduct a Phase III clinical trial with the proposed FDC.

Accordingly, the expert panel suggested that the Phase III clinical trial protocol should be submitted to CDSCO for further review by the committee.

Also Read: Dr Reddy’s Laboratories Gets CDSCO Panel Nod for Marketing Approval of Siponimod Tablets

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NMC to Introduce Centralised Software System to Streamline MBBS Admissions, Clip Backdoor Entries

New Delhi: The National Medical Commission (NMC) is in talks with the State Counselling authorities to launch a centralized software system for MBBS admissions in the next academic session, Education Times has reported.

NMC is introducing this software to bring transparency and accountability in medical admissions as this software is expected to streamline the admission process across the States and reduce irregularities by integrating a common platform for student intake verification.

Confirming the Commission’s plans in this regard and the fact that NMC is in talks with the State counselling authorities, Dr. B Srinivas, the Secretary of NMC said, “Currently, counselling takes place at the state level. If we have a common software in place, many irregularities will be caught in the initial stage. We are in talks with several state counselling authorities to come together for a centralised system.”

Also Read: NMC Extends Deadline to Submit MBBS Admission Details

“However, we think that this might take time and will be only possible by the next academic cycle. Until then, the NMC will continue to enforce its current online monitoring system, which has already proven effective in identifying and preventing unauthorised admissions,” he further informed Education Times.

At present, under the NMC rules, the medical colleges are required to submit the details of the students enrolled in the first year of the MBBS programmes. Medical Dialogues had earlier reported that recently the Apex Medical Education Regulatory Body directed NMC to submit the details of students admitted to the MBBS course for the academic year 2024-2025 by November 8, 2024. This deadline was further extended later to 23.11.2024.

NMC introduced the online monitoring system to effectively monitor that all MBBS admissions made are in conformity with the requirement of the Regulations. Earlier this year, it directed all the medical colleges to submit the requisite information through an online system that can be accessed through the Commission’s website. Asking the medical colleges to submit the students’ admission data within the specified deadline, it had clarified that institutes would not be allowed to enter the details of the students into “UG Admission Monitoring Module” Students Entry System for the academic year 2024-2025.

In the notice, the Commission had also asked the medical colleges to ensure that MBBS admissions for 2024-2025 are made in accordance with the provisions of the National Medical Commission Act, 2019, and the National Eligibility-cum-Entrance Test (NEET) based selection process notified by the Graduate Medical Education Regulation 2024. NMC has directed the institutes to ensure that the admissions are made in terms of the following parameters such as sanctioned intake capacity, eligibility, age limit, qualifying marks, and common counselling.

Referring to this directive, the Secretary of NMC, Dr. B Srinivas told Education Times, “The directive is a routine practice to ensure that the admissions made by the colleges are on time, and eligible candidates are selected. The system that was initiated last year, was created to improve transparency, ensuring that only eligible candidates secure seats in medical colleges. The directive aims to curb backdoor admissions, which often allow ineligible students to enrol through unauthorised means, sometimes without even passing their class XII exams or the NEET exam.”

“Last year, when this system was first implemented, the NMC discovered approximately 30-35 cases where colleges attempted to admit ineligible students. Some of these students had not passed the exams, and in some cases, colleges had not cross-verified details adequately. As a result, the NMC imposed heavy penalties, including monetary and seat reduction, on several defaulting colleges,” he added.

The system by the Commission acts as a safeguard to filter admissions and if they fail to submit accurate details and if they admit ineligible candidates, they would risk sanctions from the NMC. In this regard, Dr. Srinivas said, “The NMC has also made it clear that any admission not processed through authorised channels will not lead to a recognised degree… It has become mandatory that there will be no admissions through institutions, and only counselling authorities.”

Also Read: NMC Deadline for Medical Colleges to Submit Details of MBBS Students Admitted this academic year

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Cricket balls can concuss and even kill batters—at all levels, helmet use must be taken seriously

The 10-year anniversary of the death of much-loved Australian cricketer Phillip Hughes falls on November 27.

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