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NCT06631872
The physiological challenge of major surgery has been likened to running a marathon. In both cases, preparation is critical. Yet, many patients undergo major surgery without understanding the potential consequences. The STTARRS trial aims to test the effect of an education program delivered via telehealth in people preparing for lung or major abdominal cancer surgery , compared with usual care on the development of a respiratory complications after surgery. The secondary aims will be to determine the effect of the online education program for people preparing for lung or major abdominal cancer surgery compared to usual care on the following outcomes; acute hospital length of stay, surgical recovery, physical function and activity, self-efficacy, behaviour change, symptoms, health-related quality of life, number of days alive and out of hospital and health service usage and survival. This trial includes one sub-study. The sub-study will recruit eligible people preparing for lung cancer surgery. In the sub-study, 35 participants will receive an individualised inspiratory muscle training and walking program delivered and monitored by telehealth in addition to the main STTARRS trial intervention before surgery.
NCT06816381
This study is aiming to characterize the elasticity of the female reproductive tract including the uterus, cervix and ovary using shear wave elastography at different times during the menstrual cycle and define the standard reference range of normal uterine and ovarian elasticity. By doing so, the potential of using shear wave elastography to diagnose and predict outcomes for patients seeking fertility treatment might be established.
NCT07575022
This study aimed to compare Endoscopic Sinus Surgery with and without image guidance, analyzing a number of parameters that can impact efficacy in cases of nasal polyposis.
NCT07404969
The goal of this clinical trial is to determine whether telomere profiling and other biological aging hallmarks can help identify underlying mechanisms of persistent infertility in women with post-treatment unexplained infertility. The study also evaluates whether a personalized integrative treatment guided by these biomarkers can improve reproductive outcomes. The study includes women aged 25 to 42 years who continue to experience infertility despite appropriate management of identifiable reproductive conditions and repeated attempts with assisted reproductive technologies (ART), such as intrauterine insemination (IUI) or in vitro fertilization (IVF). The main questions this study aims to answer are: * Can telomere and biological aging hallmarks profiling identify a biological aging phenotype associated with infertility? * Can an integrative treatment guided by these profiles improve clinical pregnancy outcomes? Participants will: * Undergo a baseline reproductive evaluation and blood-based assessment of telomeres and aging hallmarks. * Receive an integrative approach combining Traditional Chinese Medicine (TCM), targeted nutritional support, and standard fertility care. * Proceed with natural conception attempts or standard assisted reproductive technologies following the preconception phase. * Participants will be followed to assess pregnancy outcomes and changes in biological aging hallmarks.
NCT07529054
Robotic-assisted gait training (RAGT) devices, such as the Lokomat®, are commonly used to support gait rehabilitation by enabling repetitive, task-specific walking movements. The functional proprioceptive stimulation (FPS) device Vibramoov® represents a novel technology designed to stimulate proprioceptors at the muscle-tendon junction through targeted vibratory stimuli, thereby activating sensorimotor centers in the brain and potentially facilitating movement execution. The aim of this randomized controlled trial is to investigate whether Lokomat® training combined with Vibramoov® leads to greater improvements in qualitative and quantitative gait parameters in stroke patients compared with Lokomat® training alone. The study will be conducted at the Gröbming Rehabilitation Center and will include patients undergoing a four-week neurological inpatient rehabilitation program. Participants will be randomly assigned to an intervention group (Lokomat® + Vibramoov®) or a control group (Lokomat® only), with 20 patients per group. Primary outcomes include the 6-Minute Walk Test (6MWT) and spatiotemporal gait parameters. Additional assessments include functional scores, patient-reported outcome measures, and blood biomarkers. Statistical analyses will be performed depending on data distribution. A follow-up assessment evaluating EQ-5D and PHQ-4 will be conducted six months after completion of the rehabilitation program.
NCT07087743
This study evaluates a novel Virtual Reality (VR)-integrated visual feedback system designed to enhance limb propulsion during robot-assisted gait rehabilitation in individuals post-stroke. In collaboration with CUREXO, a rehabilitation robotics company, the system is embedded within the Morning Walk® end-effector robot and provides real-time visual feedback to facilitate symmetrical use of the paretic and non-paretic limbs. The goal is to address gait asymmetry commonly observed in hemiparetic stroke survivors by promoting improved paretic leg propulsion, which is a key contributor to forward movement during walking. A total of 30 participants (15 stroke, 15 healthy controls) aged 20 years or older will undergo single-session gait training using the VR-robot system. Participants will be assessed using spatiotemporal gait parameters, muscle activity, foot pressure, and vertical ground reaction forces. Additional safety measures-including a saddle-type weight support and real-time heart rate monitoring via smartwatch-are implemented to ensure a safe and controlled training environment. This study aims to test the feasibility and effectiveness of this VR-based system in improving gait symmetry and functional walking capacity in people recovering from stroke.
NCT07494864
Millions of patients of all ages suffer worldwide from diverse urinary pathologies, such as lower urinary tract (LUT) dysfunction, bladder pain syndrome, urinary tract infections (UTIs), or bladder cancer. The research project investigates the interplay between the bladder and the microbiome. The goal is to evaluate the association of microbiological and immunological factors with lower urinary tract health in humans.
NCT07441161
An ambispective observational study based on two groups (ITM and ICNB) from an earlier clinical trial conducted by our team(15) and a third group (ESPB) that received the new type of block, as we sought to assess the efficacy of this procedure and compare results with the other groups.
NCT07440459
The goal of this observational study is to assess the course of motor and functional gait recovery induced by Lokomat robot-assisted gait rehabilitation in patients with spinal cord injury. The main question it aims to answer is: How does gait motor and functional multilevel recovery progress over time in patients with spinal cord injury? Assessmets will be conducted at four time points: pre-intervention, mid-intervention, post-intervention, and at 1-month follow-up after the completion of robot-assisted gait rehabilitation. Data will be collected at multiple levels, including: * Clinical tests * Three-dimensional gait analysis with kinematic, kinetic, and electromyographic measurements * Maximum isometric strength * Nerve conduction parameters
NCT07427043
This prospective, interventional, open-label, phase 3 randomized study evaluates a multimodal analgesia discharge pathway to reduce automatic opioid prescribing following routine robotic-assisted laparoscopic prostatectomy (RALP). Patients are counseled on post-operative pain management and then may opt into or out of the study with randomization to discharge prescriptions including (A) multimodal plan with additional automatic opioid prescription or (B) multimodal plan alone and instruction to call phone line to request opioid prescription if pain management is insufficient. Additionally, a cohort of historical controls prior to implementation of the study is also prospectively assessed as a pre-study baseline. The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including emergency department visits or postoperative phone calls, and same-day discharge rates.
NCT07426692
This prospective randomized controlled trial was conducted to compare the effectiveness of two ultrasound-guided regional anesthesia techniques, erector spinae plane block (ESPB) and serratus posterior superior intercostal plane block (SPSIPB), with standard patient-controlled analgesia (PCA) for postoperative pain management after video-assisted thoracoscopic surgery (VATS). Adult patients undergoing elective VATS were randomly assigned to receive ESPB, SPSIPB, or PCA alone. The primary objective was to evaluate postoperative pain intensity during the first 48 hours after surgery. Secondary outcomes included opioid consumption, rescue analgesia requirements, patient satisfaction, and postoperative complications.
NCT07409792
The goal of this clinical trial is to evaluate whether the complementary intervention of auricular point sticking therapy (APST) can improve pregnancy outcomes by ameliorating psychological distress and sleep quality in female patients aged 20-45 years undergoing in-vitro fertilization and embryo transfer (IVF-ET) who also present with anxiety and/or insomnia. The main questions it aims to answer are: Does the addition of APST to standard luteal phase support improve key IVF-ET pregnancy outcomes (embryo implantation rate, clinical pregnancy rate, ongoing pregnancy rate)? Does APST effectively reduce anxiety and depression scores (measured by GAD-7 and PHQ-9) and improve sleep quality (measured by PSQI and actigraphy) in this patient population? Are the observed clinical improvements associated with modulation of stress-related biomarkers (e.g., serum cortisol, 5-HT)? Researchers will compare the intervention group (standard care + APST) to the control group (standard care only) to see if the combined therapy leads to superior outcomes in psychological well-being, sleep parameters, and ultimately, reproductive success. Participants will be randomly assigned to either the control group or the intervention group. In the control group, receive standard luteal phase support medication (e.g., progesterone injections or oral dydrogesterone) for 4 weeks post-embryo transfer. In the intervention group, receive the same standard medication plus auricular point sticking therapy. This involves: 1.Having vaccaria seeds attached to specific ear acupoints (Heart, Liver, Endocrine, Shenmen, Subcortex, Sympathetic). 2.Performing self-acupressure on the seeds 3 times daily for 3 minutes each session. 3.Replacing the seeds at a new site every 3 days. 4.Complete psychological (GAD-7, PHQ-9) and sleep quality (PSQI) questionnaires at baseline and 12 weeks post-transfer. 5.Wear an actigraphy device on the wrist for 7 consecutive days to objectively monitor sleep patterns. 6.Provide blood samples for biomarker analysis (cortisol, 5-HT) on specific days post-transfer. 7.Undergo follow-up assessments to determine pregnancy status (β-hCG test, ultrasound).
NCT07387484
The erector spinae plane (ESP) block is a widely used regional anesthesia technique for postoperative analgesia in thoracic surgery. The block can be performed in different patient positions, most commonly sitting or lateral decubitus, but the effect of patient position on dermatomal sensory spread and analgesic efficacy has not been clearly established. This prospective, randomized, single-blind clinical trial aims to compare the effects of ESP block performed in sitting versus lateral decubitus position on dermatomal sensory distribution and postoperative analgesic outcomes in patients undergoing video-assisted thoracic surgery.
NCT07359703
In current treatments for In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI), the creation of multiple embryos is a common practice. The decision to transfer an embryo is traditionally based on the morphological assessment by an embryologist, which, due to its nature, must be considered subjective. In certain regions, invasive embryo biopsy techniques, such as Preimplantation Genetic Testing for Aneuploidy (PGT-A), are used to detect chromosomal abnormalities and support decision-making regarding embryo transfer. However, there is a medical need to improve the outcomes of IVF/ICSI cycles through non-invasive and objective methods. As an academic center, our goal is to investigate promising innovative methods that, if successful, can be integrated into standard care. The aim of the Aurora blastocyst study is to evaluate the effectiveness of the Aurora test in selecting five-day-old embryos for fresh or frozen embryo transfer. Additionally, the study assesses whether the use of the Aurora test results in an increase in clinical pregnancy rates and live birth rates. The Aurora test is a non-invasive test for evaluating oocyte competence and subsequently the embryo obtained in an ICSI cycle (In Vitro Fertilization). This test is performed on cumulus cells (CC) surrounding the oocyte and uses mRNA expression profiles to evaluate the developmental potential of the oocytes. The test has been developed and validated for patients stimulated with human menopausal gonadotropins (HP-hMG), an ovulatory dose of hCG, and a single embryo transfer on day 3. The test will be performed by Fertiga nv, upon receiving patients cumulus cells. At our center, based on earlier research, the standard care involves a single embryo transfer on day 5. In this study, embryo selection based on morphology is compared with embryo selection based on morphology and the Aurora test. Finally, this study aims to evaluate the impact of the Aurora test score on the embryologist's selection decision for transferring a five-day-old embryo for single embryo transfer, by assessing parameters such as pregnancy rates and live birth rates.
NCT07213375
The aim is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to "High-pain-responders" in patients undergoing VATS lobectomy/segmentectomy. The hypothesis is that a high dose of Dexamethasone can lower pain when coughing in the morning after VATS lobectomy/segmentectomy, in patients scoring as "High-pain-responders" on the Pain-Catastrophizing-Scale
NCT07305142
This study aims to compare perioperative, pathological, and early functional outcomes of PAL （Posterior, Anterior and Lateral）combined approach RARP and posterior approach (with Retzius space preserved) RARP in the treatment of prostate cancer.The main question it aims to answer was: What is the early therapeutic efficacy of robot-assisted laparoscopic radical prostatectomy using the combined posterior, anterior, and lateral (PAL) approach, and how does it compare with the traditional posterior approach? Participants were randomly assigned to undergo either robot-assisted laparoscopic radical prostatectomy using the PAL (posterior-anterior-lateral) approach or the classic posterior approach.
NCT07288099
This study is designed as a prospective observational cohort to evaluate recovery after video-assisted thoracoscopic surgery (VATS). In our clinic, anesthesia for VATS is commonly provided either with target-controlled infusion (TCI) or with inhalational agents, depending on the routine practice of the anesthesiologist. No randomization or additional intervention will be performed. During the study period, patients who receive either method as part of standard care will be followed, and perioperative and postoperative data will be recorded. Awakening time, extubation time, Aldrete score progression, pain levels, and early postoperative complications will be compared between the two groups. The aim is to better understand how these widely used anesthesia techniques may influence recovery in VATS patients and to support future clinical decision-making.
NCT07289295
The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and/or salpingo-oophorectomy
NCT04178551
Opioid use disorder (OUD) is a major cause of illness and death among Veterans for which effective treatment is a major priority of the Veterans Health Administration (VHA). Expanding access to alternatives to opioid medications for chronic pain management is also a leading priority. Effective medications for OUD (MOUD) are available, but their availability and use among Veterans varies across VHA. The aims of this study are to pull together the efforts of six individual pilot projects into a single project. The purpose of combining the projects is to maximize the value of the individual projects to VHA and to provide information to guide strategies to increase access and use of MOUD and alternative therapies for pain in VHA nationally. The researchers leading the individual projects will make use of their partnerships with Veterans Integrated Service Network (VISN) leaders in order to develop a combined effort toward increased dissemination and use of MOUD that spans 9 VISNs and 63 sites.
NCT04990713
Video assisted thoracic surgery (VATS) has emerged as standard of care for majority of thoracic surgeries. It is less invasive compared to thoracotomy and is associated with improved perioperative outcomes \[1-3\]. Good perioperative analgesia after thoracic surgery will enable pulmonary toilet, early chest physiotherapy and mobilisation, \[4,5,6\]. Thirty-day hospital visits and hospital readmissions at London Health Sciences Centre (LHSC) is around 21% and 9% respectively \[7\]. One of the top five determinant for hospital visit and readmission in 30 days, was persistent post operative pain \[7\]. Several options to analgesia are available for patients undergoing VATS procedure. Systemic opioid based multimodal analgesia, central neuraxial blocks like thoracic epidural and peripheral nerve blocks are different available options, and their practise varies across institution \[4,8,9\]. Thoracic epidural or paravertebral blocks can be challenging to perform with high failure rates \[10-12\]. Fascial plane blocks (SAB; ESP) are in vogue in the present era \[13-16\]. They are easy to perform and do not require similar dexterity as needed to perform thoracic epidural or paravertebral blocks. They have minimal side effects and provide the options for continuous infusion for prolonged analgesia. They have become an effective part of multimodal analgesia and have established their roles in ERAS (enhanced recovery after surgery) protocol for VATS procedures. SAB has become a common practise at our institution with proved clinical efficacy. Perioperative Surgical Home is a patient centric team-based approach to improve patient's experiences in the perioperative period and thus improve healthcare \[17\]. Quality of Recovery (QoR) is a key determinant to perioperative surgical home and can be measured using the QoR 40 score \[18\]. This is a well validated score with a minimal important clinical difference (MICD) of 6.3 \[19\]. Quality of recovery combines five dimensions of health: patient support, comfort, emotions, physical independence and pain to achieve a single patient outcome - improved patient care \[18\]. The investigators hypothesize the that patients undergoing VATS lung resections using a combination of intercostal nerve block plus continuous SAB catheter infusion of local anesthetics will have a 20% increase in their QoR-40 score 24hour after the surgery compared to a single shot intercostal nerve block.