Background: The aim of this paper is to empirically identify a treatment-independent statistical method to describe clinically relevant bleeding patterns by using bleeding diaries of clinical studies on various sex hormone containing drugs.
Methods: We used the four cluster analysis methods single, average and complete linkage as well as the method of Ward for the pattern recognition in menstrual bleeding diaries. The optimal number of clusters was determined using the semi-partial R2, the cubic cluster criterion, the pseudo-F- and the pseudo-t2-statistic. Finally, the interpretability of the results from a gynecological point of view was assessed.
Results: The method of Ward yielded distinct clusters of the bleeding diaries. The other methods successively chained the observations into one cluster. The optimal number of distinctive bleeding patterns was six. We found two desirable and four undesirable bleeding patterns. Cyclic and non cyclic bleeding patterns were well separated.
Conclusion: Using this cluster analysis with the method of Ward medications and devices having an impact on bleeding can be easily compared and categorized.
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http://dx.doi.org/10.1186/1472-6874-9-21 | DOI Listing |
Front Neurol
December 2024
Department of Epileptology and Cerebral Rhythmology, APHM, Timone Hospital, Marseille, France.
Objective: This study aims to evaluate the efficacy and safety of deep brain stimulation (DBS) of the medial pulvinar nucleus (PuM) in reducing seizure frequency and addressing comorbidities in patients with drug and vagal nerve-resistant focal epilepsy.
Methods: This is an open-label prospective treatment trial with a planned enrollment of 12 patients suffering from medically refractory epilepsy (Clinical trial gov NCT04692701), for which the interim 12-month post-implantation results for the first 6 patients are being reported. Inclusion criteria were focal epilepsy not suitable for or after failed surgical intervention and previous failure of neurostimulation therapies (vagus nerve stimulation or anterior thalamic nucleus DBS).
Pediatr Allergy Immunol
December 2024
Allergy Department, 2nd Pediatric Clinic, National and Kapodistrian University of Athens, Athens, Greece.
Background: Food protein-induced allergic proctocolitis (FPIAP) is the leading cause of rectal bleeding in infants. Tolerance is presumed to develop until the first year of age, although natural history studies are scarce, making the determination of the ideal duration for any intervention, challenging. Intestinal microbiota (IM) is crucial in food allergy development; however, data for FPIAP remain limited.
View Article and Find Full Text PDFEur J Contracept Reprod Health Care
September 2024
Exeltis Healthcare, Ismaning, Germany.
Background: Dienogest (DNG) 2 mg/ethinylestradiol (EE) 0.02 mg is the first low-dose combined oral contraceptive (COC) with a prolonged-release formulation that allows stable plasma concentrations and has high contraceptive efficacy (Pearl index: 0.2).
View Article and Find Full Text PDFJ Obstet Gynaecol Res
October 2024
"Kyo-sei Shakai" (Convivial Society) Laboratory of Unicharm Corporation, Kagawa, Japan.
Aim: The 2018 International Federation of Gynecology and Obstetrics abnormal uterine bleeding System-1 defines menstrual flow volume on a 3-point scale based on subjective assessment. However, the normal flow range has not been established, and it is unclear whether subjective assessment is accurate. We investigated the normal menstrual flow volume range in Japanese women and whether the actual measured menstrual flow volume agreed with the subjective evaluation.
View Article and Find Full Text PDFJAMA
August 2024
Bayer CC AG, Basel, Switzerland.
Importance: Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed.
Objective: To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms.
Design, Setting, And Participants: Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023).
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