Abrest, France

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered QD orally, on the reduction of SBP in approximately 300 participants aged ≥ 18 years with HTN (≥ 140 mmHg at Screening; ≥ 135 mmHg at randomisation) despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uHTN); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (rHTN).

Biofeedback With Heart Sound Following Trauma

Background: Some countries have suffered and will continue to suffer great destruction as a result of wars, epidemics, earthquakes, and other natural catastrophes. When individuals are exposed to specific psychological or physical traumas, they can develop stress-related disorders. This can lead to irreversible changes in the autonomic nervous system and cardiovascular disorders. When subjected to a new stress test, traumatized/previously exposed participants may show more pronounced behavioral changes, intolerance, and greater fatigue responses as compared to pre-trauma. To reduce trauma-associated responses from recurring again in the future, especially in young people, it is necessary to take preventive measures. Alternative solutions must be designed for counseling, medication, phytotherapy, etc. This study aims to examine how individuals cope with trauma-related situations using a biofeedback method, which could be developed to manage stress-related coping. The emotional and psychological states of earthquake victims will be assessed using a protocol based on biomedical (neuro-cardiac) signals and the sound of the person's own heart. This sound will be applied at a fixed frequency or in real-time with allostatic auditory stimulation. A resonance stabilizing the autonomic nervous system will thus provide biofeedback to the participants. Methods: To examine the different states, biological signals will be measured and recorded, such as electrocardiography (ECG), phonocardiography (PCG), electrodermal activity, respiratory rhythm, and near-infrared spectroscopic imaging (fNIRS). Deep learning models will optimally process the collected data and evaluate the results. Impact: The Project aims to assess the long-term risk of trauma-induced stress in young persons. Using non-invasive sound therapy to assess the effects on the vagal nerve via cardiovascular effects and neural activity will provide biofeedback in these individuals.

Prevalence of Hirsutism in Turkey: Data of The Dermatoendocrinology Study Group

Twenty-two provinces of Turkey's seven regions and 26 hospitals from these provinces will be included in the study. The number of samples was specified by the public health specialist on the 2018 census figures. The Turkish population consists of 80,810,525 people according to the data announced by the Turkish Statistical Institute in 2018. In order to determine the prevalence in Turkey, the sample size was calculated with a confidence interval of 99% and error margin of 1%, and the total number of individuals to be screened was designated as 5861. The number of patients to be screened via the clustering method weighted by regions was specified as 1800 for the Marmara Region, 750 for the Aegean Region, 744 for the Mediterranean Region, 568 for the Black Sea Region, 932 for the Central Anatolia Region, 434 for the Eastern Anatolia Region and 633 for the Southeastern Anatolia Region. The provinces that were thought to represent each region were selected via the cluster sampling method. During the study period, female patients aged between 18 and 45, who present to dermatology outpatient clinics, will be examined clinically until the number of patients designated for each study center is reached, and the hirsutism level of the patients diagnosed with hirsutism will be determined by using the modified Ferriman-Gallwey (mFG) scoring system. In this system, hair growth in nine regions (upper lip, chin, chest, upper back, lower back, upper abdomen, lower abdomen, upper arms and thighs) is graded between 0 and 4. And nine regions are scored between 0 (no terminal hairs) and 4 (excessive presence of terminal hairs). The score above 8 is considered hirsutism. The hirsutism family history, body mass index, menstrual cycle pattern, concomitant disease status (diabetes, hyperlipidemia, hypertension, thyroid disease), history of medication causing body hair growth, the acne presence and severity, presence and severity of androgenic alopecia, presence of seborrhea, presence and localization of acanthosis nigricans, presence of acrochordon, presence of hidradenitis suppurativa, presence of galactorrhea, presence of virilization symptoms and presence of cushingoid symptoms of all the examined patients will be investigated and recorded.

Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab versus placebo as added to SOC (consisting of MMF and glucocorticoids) in adults with active proliferative Class III or Class IV LN (both with or without concomitant Class V). The total study duration may be up to approximately 116 weeks, including the Screening and Follow-up. Approximately 360 participants will be randomized in a 1:1 ratio to receive anifrolumab or matching placebo throughout during the Treatment Period.

The Effect of Breastfeeding Support Provided Via Video-conferencing

Investigate the Renal Movement by Single Lung Ventilation in Patients Administered RIRS for Kidney Stones.

In recent years open surgical treatment has changed to minimal invasive treatments for kidney stone treatment. Additionally, the treatment choices vary depending on the localization of the stone and its dimensions. In the European Urology Association (EUA) guidelines, it states the RIRS method can be used to treat stones up to 2 cm in the kidney. Due to RIRS the operation and scopy durations and hospital stay have clearly reduced compared to the standard treatment of percutaneous nephrolithotomy. However, the high hydrostatic pressure applied to the renal pelvis during RIRS may cause unwanted results in the postoperative period such as hydronephrosis and loss of renal parenchyma. During the operation, the stone may move during deep inspirium and expirium sequences linked to deep ventilation which may lengthen the operation and scope durations and brings risks such as perforation during laser lithotripsy application. In this study we aimed to apply single lung ventilation during the operation (one of the indications for single lung ventilation is to increase surgical view and ease manipulation) to minimize renal movement on that side and reduce peroperative and postoperative complications.

Comparison of TAP Bock vs QL Block in Varicocele Surgery

Purpose:TAP is the application of local anesthetic agents to block the anterior neck of the thoracic intercostal (T7-T12) and first lumbar (L1) nerves in the anatomic neurofascial gap between the internal oblique and transversus abdominis muscle located in the anterolateral region of the abdomen. It was first described by Rafi in 2001. Then in 2007 Hebbart et al. described that using USG, TAP block could be implemented more effectively and safely. With QL block, a local anesthetic agent is applied to the posterior layer of the thoracolumbar fascia and similar nerve blockage is achieved. The technique was first described by Blanco in 2007. TAP block and QL block may be a good method for postoperative pain control. We aimed to compare the efficacy of TAP block and QL block to analgesic consumption after varicocelectomy operations, analgesic side effects and analgesia quality and to compare these two block efficacy. Material & Method:75 patients in the ASA I-II risk group, aged 18-45 years, who will undergo elective varicocelectomy surgery, will be randomized using the cohort procedure. The patient will be informed about the study and will be included in the study after the patient is approved with the approval form. The three groups will be divided into TAP Group (Group T) n = 25, QL Group (Group Q) n = 25, Control Group (Group K) n = 25. A total of 75 patients were planned to receive α = 0,05 at the β: 0.20 level and 0.80 at the power level and n = 25 for each group. Reference work including VAS scores and I-TAP method was taken into consideration when the sample size of the study was determined. The normal distribution of data in the statistical evaluation of the study will be examined by the Shapiro-Wilk test. One-way ANOVA will be performed for comparison of groups (if the data are normally distributed). Multiple comparisons Tukey test, Dunnett test Tamhane T2 test will be applied. (Kruskal-Wallis H test will be applied in cases where it does not normally disperse.) Multiple comparison will be performed with the Dunn-Sidak test. Statistical significance is accepted as p <0.05, data will be examined in the IBMSPSS program. All three patients will be operated on with spinal anesthesia. Patients with coagulopathy who are contraindicated for spinal anesthesia, known allergies to the drugs to be used, infected and non-voluntary patients to be excluded from the study. At the end of the disease operation in Group T, after the necessary antiseptic conditions are established in the supine position, the USG probe midpoint (within the petit triangle). After the abdominal muscle layers are seen, the facial muscle sensation is taken when the needle-like muscular layers and facial muscles pass, and the needle is controlled with USG. After receiving the second click feeling (passage of the internalocutaneous fascia), the needle-like localization will be determined by applying a test dose of 0.5-1 ml. After localization is confirmed, frequent aspiration and local anesthetic agent will be given to the neurophysiologic plan and TAP block will be applied. To apply the lateral QL block to the patient in Group Q, a low frequency convex probe is inserted into the patient while the patient is in the supine position. Quadratus lumborum block 1 is injected with 20 mL of local anesthetic on the lateral side of the QL muscle in the area where the transversus abdominis muscle contacts the transversal fascia at the level that enters the aponeurope. Local analgesics will not be administered with Group III disease needle. When the patient is removed to the postoperative care unit, an iv patient-controlled analgesia device will be applied. Patients in all three groups will be assessed with a resting and cough VAS (visual analog scale) at postoperative 2,4,6,12,18 and 24 hours (pain intensity: 0 no pain and 10: the most severe pain I have ever heard) and values will be recorded. When the patient has a pain, an analgesic agent will be given according to the patient-controlled analgesia protocol. The amount of analgesic agent consumed by the patients when the first analgesic agent is needed and 24 hours will be recorded. Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. In addition, patient satisfaction will be assessed with these methods as bad, medium, good, and very good.