FDA authorises marketing of light therapy as treatment of AMD

The US Food and Drug Administration has FDA has granted marketing authorization to a form of light therapy as the first-ever treatment for dry age-related macular degeneration (AMD).

The LumiThera’s Valeda Light Delivery System is the first treatment shown to improve vision loss associated with dry AMD. The new photobiomodulation (PBM) system generates light at different wavelengths to stimulate and improve the function of retinal mitochondria.

The Valeda therapy is the first ever authorized treatment by the FDA for vision loss in dry AMD patients. Valeda provides an improvement in best corrected visual acuity (BCVA) over 24 months of >5 letters or equivalent to a line on the eye chart. In the pivotal U.S. LIGHTSITE III trial, the Valeda treatment met its primary endpoint and was shown to be safe and effective in increasing and maintaining improved visual acuity.

LumiThera submitted the US LIGHTSITE III clinical data as part of a technical package to the FDA under a De Novo request with special controls.

“The De Novo authorization established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda Light Delivery System,” stated Lori Holder, Vice President, Regulatory Affairs, LumiThera, Inc.

“The RCT results demonstrated clinical benefits in early to intermediate dry AMD patients out to 24 months and an excellent safety profile,” stated David Boyer, MD, Retina Vitreous Associates Medical Group, Beverly Hills, CA. “Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process. This is an exciting option for patients and something doctors and patients have been waiting for.”

“The primary endpoint for the study was visual acuity gain,” indicated Glenn Jaffe, MD, Duke Reading Center. However, we also followed multiple anatomical endpoints from BL throughout the 24-month study to determine whether PBM helped to preserve retinal anatomy. The PBM treatment had a beneficial effect on multiple anatomic biomarkers. For example, we looked at whether PBM affected progression to geographic atrophy and found that incident geographic atrophy was reduced in the PBM-treated eyes compared to the sham treated eyes respectively, 6.8% versus 24%. Although incident GA was not a prespecified clinical endpoint, the results supported overall safety benefits of treating earlier in dry AMD disease.

“We have been working hard to bring Valeda, a multiwavelength photobiomodulation device to our U.S. patients for several years. We now have a non-invasive treatment option for dry AMD patients that may improve vision and address the disease earlier, before permanent vision loss,” stated Clark Tedford, Ph.D., President and CEO. “The FDA authorization of the Valeda treatment to improve vision in dry AMD now provides a significant option for our US patients.”

About AMD

AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45-49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).

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Psilocybin promising treatment for anorexia nervosa, reveals first clinical trial

In a groundbreaking exploration of psychedelic medicine’s potential for treating one of psychiatry’s most challenging conditions, researchers at University of California, San Diego (UCSD) provided an analysis and further details of a trial published in Nature Medicine that had shown how psilocybin therapy affects individuals with anorexia nervosa. In the new peer-reviewed Emerging Topic article in Psychedelics the authors of the original trial offer “a granular view of findings based on qualitative data from semi-structured interviews, extensive feedback and interviews from participants, and [their] subjective interpretations of data patterns.” This new Emerging Topic review reveals both promising outcomes and important limitations that could shape future treatment approaches.

The study, published November 7, 2024, in Psychedelics, offers a unique first-hand perspective on how psilocybin treatment impacts patients with anorexia nervosa, a condition that maintains the highest mortality rate among psychiatric illnesses and has historically resisted conventional treatments.

“Our findings suggest that psilocybin may be helpful in supporting meaningful psychological change in a subset of people with anorexia nervosa,” says Dr. Stephanie Knatz Peck, lead author of the study. “What’s particularly interesting is that 60% of participants reported a reduction in the importance of physical appearance, while 70% noted quality-of-life improvements and shifts in personal identity.”

Key findings from the trial include:

• 90% of participants ranked their psilocybin session among their top five most meaningful life experiences

• Four out of ten participants showed clinically significant reductions in eating disorder psychopathology

• Treatment effects were most pronounced in shape and weight concerns

• Changes in psychological outlook didn’t automatically translate to weight restoration

The research raises intriguing questions about the intersection of psychedelic medicine and eating disorder treatment. Why do some patients respond dramatically while others show minimal improvement? How might genetic variations in serotonin receptors influence treatment outcomes?

“You are able to act in a way that maybe had felt unachievable before if you set the right intention,” reported one participant, while another noted, “Things might not look that different from the outside, but they feel completely different from the inside.”

The study employed a single 25mg dose of psilocybin combined with specialized psychological support before, during, and after administration. While the results show promise, they also highlight the complexity of treating anorexia nervosa, suggesting that psychedelic therapy might work best as part of a comprehensive treatment approach rather than a standalone intervention.

Dr. Walter H. Kaye, senior author and director of the UCSD Eating Disorders Treatment Center, emphasizes the need for larger, well-controlled studies that include brain imaging and genetic analysis to better understand who might benefit most from this novel treatment approach.

The findings open new avenues for research into personalized medicine approaches for eating disorders, while also raising important questions about how to optimize therapeutic protocols for this vulnerable population.

Reference:

Stephanie Knatz Peck, Hannah Fisher, Jessie Kim, Samantha Shao, Julie Trim, and Walter H. Kaye, Psychedelic treatment for anorexia nervosa: A first-hand view of how psilocybin treatment did and did not help, Psychedelics, https://doi.org/10.61373/pp024e.0034.

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Chili Peppers may Exhibit Antitumor Effect on Mesothelioma Cancer Cells: Study

Capsaicin, the compound in chili peppers which gives them their spicy taste, may become a source of new, natural drugs for the hard-to-treat Mesothelioma type of cancer.

Mesothelioma is a very aggressive cancer with very poor survival and limited therapeutic options, commonly, but not always, associated with exposure to asbestos.

The paper, “Capsaicin Exerts Antitumor Activity in Mesothelioma Cells,” describes the discovery in the international-peer-reviewed journal Nutrients.

In this study, the authors demonstrated that treatment of various mesothelioma cell lines covering all mesothelioma subtypes inhibits several biological parameters of transformation. In addition, these results supported an antitumor effect of capsaicin on cisplatin-resistant mesothelioma cells, suggesting that it may enhance therapy by reducing resistance to cisplatin.

“This research could pave the way for further studies to evaluate the use of capsaicin for mesothelioma treatment,” says Antonio Giordano, M.D., Ph.D., President of the Sbarro Health Research Organization (SHRO) and Professor at Temple University. “There is evidence that capsaicin may sensitize mesothelioma cells to chemotherapy, making treatment more effective, and that it may reduce the spread of mesothelioma.”

Reference:

Emanuela Andretta et al, Capsaicin Exerts Antitumor Activity in Mesothelioma Cells, Nutrients (2024). DOI: 10.3390/nu16213758.

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Experimental study reveals Effectiveness of membrane sweeping with cervical massage for pre-induction cervical ripening

The first stage of labor using artificial means instead of
natural means is called induction of labor (IOL). The most frequent obstetrics
operation is this one. In recent years, the rate has sharply increased.
Pregnant women with diabetes mellitus, postdate pregnancies, preeclamptic patients,
IUGR, and PPROM all undergo it. The technique employed should be efficient
financially and have minimal negative effects since it is the most prevalent
operation. Uterine pressure is more needed for an immature cervix than a ripe
one.

Induced labor is associated with failure to progress,
prolonged labor, fetal distress, and a rise in cesarean sections when the
cervix is not mature enough to allow for a successful vaginal birth. Bishop scoring
measures the ripening of the cervical papilla. When the bishop score is less
than, cervical ripening treatments are suggested. Bishop’s scoring method for
predicting vaginal delivery in multiparas at term while receiving IOL has been
effective repeatedly. Although recognizing its general simplicity and use, it
may be time to reconsider the Bishop Score assessment’s usefulness in
predicting vaginal delivery in contemporary practice, especially in light of
its expanding usage with nulliparous and preterm patients. Finding biomolecular,
imaging, or other signals that predict the cervix’s preparation for vaginal
delivery after IOL is difficult.

The ultimate goal would be to time IOL surgeries
specifically to get the greatest outcomes for each pregnancy. It is common
knowledge that pregnancies over the due date may result in issues for the
fetus, the newborn, and the mother. Risks rise after 40 weeks of pregnancy and
dramatically after 41 weeks, making this the most frequent reason for inducing
labor in the hopes of a vaginal birth. The cervical ripening and labor
induction procedures ideally call for hospital admission. However, individuals
often choose against medical advice to wait for spontaneous labor pains because
they feel uncomfortable. However, government hospitals are often overrun with
patients in a growing nation like India. It is thus desirable to use any
procedure that is both safe and efficient that might reduce hospital stays and
monetary costs without endangering the health of the pregnant woman or the
fetus. Membrane Sweeping (MS), a straightforward technique that is used all
around the globe to encourage cervical ripening, is quite popular. It’s still
unclear when membrane sweeping should be done to guarantee efficacy

An inexpensive and efficient cervical ripening and medical
induction medication is misoprostol, a PGE1 analog. The aforementioned
components could be taken orally or systemically, which is advantageous in
tropical nations with few resources. Pregnant women’s particular requirements
and worries are the main focus of cervical massage during pregnancy. This
specific massage method is intended to lessen the stresses of bearing the
additional weight, hormonal changes, and postural changes intrinsic to the
prenatal period to improve physical and emotional wellbeing. Cervical massage
develops as a complete method for encouraging relaxation, alleviating pain, and
fostering peace for both the mother and the developing baby by fusing expert
touch with a thorough knowledge of the pregnant body. The efficiency of
cervical ripening may be increased, and labor to begin spontaneously before a
formal induction treatment is required by combining membrane sweeping with
cervical massage. This study compares the efficacy of membrane sweeping with
cervical massage in terms of effectiveness. This study’s secondary goal is to
compare the maternal and newborn morbidity connected to the two methods.

A total of 150 low-risk singleton pregnancies with a
Modified Bishop Score (MBS) of fewer than five at 38 weeks of gestation were
included. The experimental group received membrane sweeping with cervical
massage, and the control group, which just received membrane sweeping, was
randomly allocated to the participants. 48 hours after the intervention,
changes in the MBS were used to gauge cervical favorability. Neonatal
morbidity, membrane rupture, intrapartum and postpartum infections, and other
complications were assessed.

The mean ages and MBS of the primigravidae in the two
research groups at induction were similar. After the intervention, the trial
group’s mean MBS was significantly higher than the control groups. Because of
this, primigravidae observed a substantial change in the MBS after the
operation. The experimental group’s adverse effects and neonatal morbidity were
comparable, except cardiotocographic abnormalities were observed more often in
the control group.

The results of the present investigation revealed that
whereas spontaneous labour did not vary in a quantitatively meaningful way
following the intervention, cervical massage is just as efficient as membrane
sweeping in attaining cervical ripening for labor induction at term in
primigravidae.

Cervical massage combined with membrane sweeping is an
alternative to membrane sweeping that might be a suitable choice for
pre-induction cervical ripening in term mothers. This is particularly true when
the cervical os is closed, and membrane sweeping cannot be performed due to the
lack of access.

In addition, the findings of the present research
demonstrated that cervical massage and membrane sweep would not have a negative
impact on the outcomes for the neonates. This research shows a possible
decrease in the time needed for labor induction in the experimental group. This
discovery is important because it may result in less medical intervention and
more effective labor. Therefore, there was insufficient evidence to conclude
that cervical massage amplifies the adverse outcomes for the mother or the
newborn in the present investigation. As a result, this research demonstrated
that membrane sweeping and cervical massage had similar effects on maternal and
newborn outcomes. Thus, cervical massage is a safe intervention regarding the
danger of infection and prelabor membrane rupture. Although the findings of
this study are encouraging, it is important to acknowledge the need for more
investigation. To completely demonstrate the effectiveness and safety of this
intervention, larger sample sizes, different demographics, and long-term
follow-ups are required. It would also be beneficial to look at any variances
in results depending on unique patient characteristics.

Source: Supriya et al. / Indian Journal of Obstetrics and
Gynecology Research 2024;11(1):47–52;

https://doi.org/10.18231/j.ijogr.2024.009

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Bariatric surgery imore cost effective than newer weight loss drugs alone, finds study

Newer weight loss drugs are cost effective in the long term only when combined with bariatric weight loss surgery, according to a study presented at the American College of Surgeons (ACS) Clinical Congress 2024 in San Francisco, California. Further, a second study presented at the meeting found that this increasingly popular class of weight loss drugs, called glucagon-like peptide-1 receptor agonists, or GLP-1 RA, appears safe and may be a novel approach to treating obesity when used before bariatric surgery.

Originally used to treat Type 2 diabetes, liraglutide (branded as Saxenda) and, more recently, semaglutide (branded as Wegovy) injections were approved by the U.S. Food and Drug Administration (FDA) for weight loss in patients with obesity or overweight and at least one weight-related health condition. These prescription medications lead to weight loss by mimicking hormones in the body that suppress appetite and increase a sense of fullness.

People must use a GLP-1 RA indefinitely to maintain weight loss, said the first study’s lead author, Joseph Sanchez, MD, a general surgery resident at Northwestern Medicine, Chicago.

“GLP-1 RA are lifelong medications for obesity management that are not always covered by insurance and can cost some people $800 to $1,200 per month out-of-pocket,” Dr. Sanchez said. “But we didn’t know how these medications compared in cost effectiveness with the gold-standard obesity management option, bariatric surgery.”

Anne Stey, MD, FACS, the study’s senior investigator and an assistant professor of surgery at Northwestern University Feinberg School of Medicine, Chicago, emphasized the importance of this information.

“As evidence of health benefits of GLP-1 RA continues to come out, insurance companies will have to decide whether they will cover these medications and in which case scenarios,” Dr. Stey said. “Understanding if and how these different obesity management options are cost effective is critical to ensure as many people have access to these medications as possible.”

Cost-Effectiveness Study

Dr. Sanchez and colleagues performed a cost-effectiveness analysis of GLP-1 RA therapy alone and bariatric surgery alone — either gastric bypass or sleeve gastrectomy. They also studied the cost effectiveness of bariatric surgery in conjunction with treatment with GLP-1 RA to prevent weight regain.

The investigators predicted the costs of each of these treatments until death (up to 50 years) for thousands of patients from different clinical trial findings around the United States. The researchers considered a treatment to be cost effective if the total cost was less than $100,000 per quality-adjusted life year (QALY). A QALY is one adequately healthy year of life a patient could gain from treatment.

At $17,400 to $22,850, the estimated cost of bariatric surgery exceeded the average yearly cost of $9,360 to $16,200 for GLP-1 RA, the researchers found. However, compared with these medications alone, bariatric surgery added approximately two QALYs and would save a patient more than $9,000 to earn a year of quality life. GLP-1 RA combined with bariatric surgery would save more than $7,200 per QALY versus surgery alone and added more than five QALYs.

“Undergoing bariatric surgery is more cost effective in the long run than maintaining these medications for the remainder of an individual’s life,” Dr. Sanchez said. “The critical role for these medications from a cost-effectiveness perspective is to use these medications to address weight regained after bariatric surgery.”

These results could change later, he said, if the cost of these medications decrease or if new, lower-priced weight loss medications become available. However, he added that the cost would have to decrease by nearly 75%.

GLP-1 RA Used Before Surgery

A study from Indiana University (IU) School of Medicine in Indianapolis found that the use of GLP-1 RA in the year before bariatric surgery has increased more than threefold since 2018-from 8% to 24%.

Some researchers have proposed using GLP-1 RA medications before bariatric surgery to help lower the weight of patients with a body mass index (BMI) greater than 50, which can make the operation more complex, said Tarik Yuce, MD, MS, the study’s senior investigator, an ACS Associate Fellow, and an assistant professor of surgery at IU School of Medicine. A BMI of 40 or greater is considered severe obesity.

“Losing weight can perhaps make the surgery easier and safer, so that’s an exciting potential avenue for these medications,” Dr. Yuce said.

According to Qais AbuHasan, MD, an IU School of Medicine research fellow and the study’s lead author, the study’s purpose was to determine whether any adverse effects occur with the use of GLP-1 RA before bariatric surgery. Patients may have used the medication to treat diabetes, to lose weight, or both.

The research team studied outcomes for 2,169 patients who underwent bariatric surgery at three IU-affiliated hospitals from 2018 through 2023. Outcomes evaluated included differences in 30-day hospital readmissions, emergency department visits, and complications for patients who preoperatively used GLP-1 RA (293 patients) and patients who did not (1,876 patients).

Dr. AbuHasan reported no statistically significant differences between treatment groups in these short-term outcomes or in the percentage of total weight loss one year after surgery. Patients who used GLP-1 RA preoperatively lost a median of 25.5% of their total weight one year after the operation, and patients who did not use these medications lost 27.3% of total weight.

“It might be safe to use GLP-1 RA in the preoperative period,” he concluded. “But we need to investigate further to determine whether factors such as the dose and duration of treatment may or may not lead to any differences in outcomes.”

Reference:

Sanchez J, et al. Comparative cost-effectiveness analysis of bariatric surgery and GLP-1 receptor agonists for the management of obesity, Scientific Forum, American College of Surgeons (ACS) Clinical Congress 2024. 

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AI-based solutions accurately and reliably evaluate root canal filling, claims research

Artificial intelligence based solutions present accurate and reliably evaluated root canal filling, claims research published in the Oral Radiology.

Artificial intelligence (AI) since it was introduced into dentistry, has become an important and valuable tool in many fields. It was applied in different specialties with different uses, for example, in diagnosis of oral cancer, periodontal disease and dental caries, and in the treatment planning and predicting the outcome of orthognathic surgeries.

This work proposes a novel method to evaluate root canal filling (RCF) success using artificial intelligence (AI) and image analysis techniques. 1121 teeth with root canal treatment in 597 periapical radiographs (PARs) were anonymized and manually labeled. First, RCFs were segmented using 5 different state-of-the-art deep learning models based on convolutional neural networks. Their performances were compared based on the intersection over union (IoU), dice score and accuracy. Additionally, fivefold cross validation was applied for the best-performing model and their outputs were later used for further analysis. Secondly, images were processed via a graphical user interface (GUI) that allows dental clinicians to mark the apex of the tooth, which was used to find the distance between the apex of the tooth and the nearest RCF prediction of the deep learning model towards it. The distance can show whether the RCF is normal, short or long. Model performances were evaluated by well-known evaluation metrics for segmentation such as IoU, Dice score and accuracy. CNN-based models can achieve an accuracy of 88%, an IoU of 79% and Dice score of 88% in segmenting root canal fillings. The study demonstrates that AI-based solutions present accurate and reliable performance for root canal filling evaluation.8

Reference:

Çelik, Berrin, et al. “Evaluation of Root Canal Filling Length On Periapical Radiograph Using Artificial Intelligence.” Oral Radiology, 2024.

Keywords:

AI-based, solutions, present, accurately, reliably, evaluate, root, canal, filling, claims research, oral radiology, Çelik,

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Vitamin D Deficiency Linked to Increased Sleep Apnea Severity in Children: Study

Researchers have identified that children deficient in vitamin D experience more severe symptoms of obstructive sleep apnea (OSA) than children with sufficient vitamin D levels. A new cross-sectional study published by Dr. Cristina Baldassari and colleagues from the Children’s Hospital of the King’s Daughters and Eastern Virginia Medical School found that a significantly lower vitamin D level was associated with a greater severity of OSA among children who were scheduled to undergo adenotonsillectomy. This study was published in the journal of JAMA Otolaryngology.

OSA is another common sleep disorder among the children characterized by recurrent complete or partial obstructions within the upper airways while asleep. Previous associations include metabolic dysfunction, cardiovascular disease, asthma, and upper respiratory infections that could potentially influence sleep quality and respiratory function. It is unknown how vitamin D deficiency mechanistically relates to OSA.

Seventy-two children, aged 2 to 16 years with severe OSA were studied. Inclusion criteria for this study are severe OSA, an obstructive Apnea-Hypopnea Index (AHI) of 20 or more, as observed during polysomnography. Patients were recruited from a tertiary pediatric otolaryngology clinic and had no history of neuromuscular disorders or craniofacial abnormalities and no history of tonsil or adenoid surgery before enrollment. Fasting blood samples were drawn for baseline assessment after induction with anesthesia, and the patients were tested for 25-hydroxyvitamin D levels. Deficient was defined as < 20 ng/mL. The obstructive AHI score in apnea and hypopnea events per hour was the primary outcome.

  • Compared to those children who were vitamin D deficient, those who had normal levels of vitamin D had a lower mean AHI score by a mean difference of -14.6 (95% CI -27.2 to -2.2), meaning that they experienced fewer severe symptoms of OSA.

  • The decrease in serum vitamin D levels at a reduction of 1.0 unit in the serum concentration was associated with an increase in the AHI value of 0.7 (95% CI: 0.04 – 1.40); even mildly decreased levels of vitamin D enhance the severity of OSA.

  • Univariate analysis indicated that vitamin D deficiency was associated with younger age (mean difference -5.0 years, 95% CI -7.2 to -2.8), Black race (OR 4.3, 95% CI 1.4-14.3), and female sex (OR 4.8, 95% CI 1.7-12.5), although these associations lost significance in the multivariable model.

This study identified a clear association between vitamin D deficiency and greater severity of OSA in children, leaving the implication that correcting deficiency may be a means for improving outcomes for sleep apnea. Vitamin D supplementation may represent an easy-to-implement, accessible manner to enhance OSA treatment in children, pending more research, as it remains a “low-hanging fruit” for intervention.

Reference:

Bluher, A. E., Kearney, T., Vazifedan, T., & Baldassari, C. M. (2024). Vitamin D deficiency and pediatric obstructive sleep apnea severity. JAMA Otolaryngology– Head & Neck Surgery. https://doi.org/10.1001/jamaoto.2024.3737

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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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