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Treatments in Women Veterans With Insomnia and PTSD

Insomnia PTSD Women Veterans

This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment and the psychoeducational intervention is modeled after usual care in a VA Women's Mental Health Clinic. The study objectives are to: 1) Iteratively refine the structure and materials of trauma-informed CBT-I in preparation for a pilot trial, 2) Pilot test the effects of trauma-informed CBT-I on PTSD treatment readiness and engagement in a sample of women Veterans, and 3) Examine potential mechanisms underlying variations in PTSD treatment readiness and engagement over time among women Veterans. Women Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Then Veterans who meet all eligibility criteria will be randomly assigned to trauma-informed CBT-I (n=25) or the psychoeducational intervention (n=25). Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=50) will have 2 follow-up assessments (post-treatment and 3-months). The follow-up assessments will collect information on PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Chart reviews will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (treatment engagement measure). Qualitative interviews will be conducted to identify mechanisms underlying PTSD treatment engagement.

Начало: 01.06.2023 Край: 31.12.2028 Възраст: от 18 г.

United States VA Office of Research and Development NCT05683132

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Lynch Syndrome X-Talk of Enteral Mucosa With Immune System

Lynch Syndrome Lynch Syndrome I Lynch Syndrome II Lynch Syndrome I (Site-specific Colonic Cancer) +18

Lynch syndrome (OMIM #120435) is the most common dominantly inherited colorectal cancer syndrome with an estimated prevalence of 1:270 individuals. It increases the lifetime risk of colorectal and endometrial cancer primarily, but it is associated with a high risk of other cancers (pancreas, stomach, ovarian, central nervous system, skin, among others). It is caused by a germline mutation in one of four DNA mismatch repair genes or a terminal deletion of the MSH2-adjacent gene EpCAM. Despite adherence to cancer surveillance programs, many patients still develop colorectal cancer and endometrial cancer. The Prospective Lynch Syndrome Database (PLSD) suggests that more frequent surveillance intervals do not significantly improve cancer risk reduction. The PLSD also revealed that the incidence of colorectal cancer in MLH1 and MSH2 carriers was even higher than previously expected, reaching as high as 41-36% among MLH1 carriers, regardless of ethnic background. The development of colorectal cancer despite surveillance is an unresolved question. Therefore, there is an unmet need for effective cancer prevention strategies.

Начало: 01.06.2023 Край: 01.06.2034 Възраст: от 18 г.

Italy, United States San Raffaele University NCT06708429

Набира участници Фаза 4

Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis

Sepsis Ivabradine Hemodynamics Heart Rate Control

Sepsis, a life-threatening syndrome, is often accompanied by tachycardia in spite of adequate volume resuscitation to correct hypovolemia and vasopressor medication to correct hypotension. Recently, relevant studies have shown that sustained tachycardia in sepsis was also related to high mortality, and appropriate control of heart rate could improve prognosis. Ivabradine reduces heart rate directly without a negative inotropic effect through inhibition of the If ionic current，which is absent from the traditional rate control drug (beta-blockers). This is a prospective, multicenter, randomized, open label study designed to compare ivabradine with placebo on the difference of heart rate and haemodynamics in patients with sepsis.

Начало: 01.06.2023 Край: 31.05.2027 Възраст: от 18 г.

China Second Affiliated Hospital of Guangzhou Medical Univers NCT05882708

Набира участници Фаза 2/3

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

Heart Failure Left Ventricular Systolic Dysfunction

This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.

Начало: 31.05.2023 Край: 15.04.2032 Възраст: 29–17 г. Лечение

Belgium, Brazil, Canada +26 Merck Sharp & Dohme LLC NCT05714085

Набира участници Фаза 1/2

Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors

Locally Advanced Solid Tumor

This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types. The study drug, TNG462, is a selective PRMT5 inhibitor administered orally. The study is planned to treat up to 225 participants.

Начало: 26.05.2023 Край: 01.09.2026 Възраст: от 18 г.

France, Spain, United States Tango Therapeutics, Inc. NCT05732831

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Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome

Myofascial Pain Syndrome - Lower Back Myofascial Pain Syndrome - Neck Myofascial Pain Syndrome - Tension Headache

Sonodyn is an investigational device that within this clinical investigation is intended for use in patients suffering from low back pain, tension headache or neck pain, originating from therapy-resistant myofascial pain syndrome. Myofascial pain syndrome is a prevalent pain condition in the adult population and a common cause of pain and dysfunction in the musculoskeletal system. It is a trigger point-induced regional musculoskeletal pain disorder affecting one or more muscles or groups of muscles. Sonodyn is a handheld medical device that combines low-energy ultrasound, electrical and magnetic field stimulation for non-invasive transcutaneous treatment of chronic myofascial pain syndrome. Sonodyn is a battery-operated, rechargeable stimulation device to be placed over specific trigger points for associated pain patterns in the human body. It emits ultrasound, electrical and magnetic stimulation signals with a pre-defined set of parameters for each of the independently operated power sources. The study will follow a prospective, randomized, sham-controlled, double-blind parallel group design. It will be conducted as a multi-center investigation at 6 sites in Austria and Switzerland. Patients are randomized in a 2:1 ratio into Treatment and Control. * Active Sonodyn therapy (Treatment) * No therapy (Sham Control) Two types of Sonodyn devices will be used: a fully functional one for Therapy arm patients that can deliver stimulation, and a non-functional one for Control arm patients that cannot convey any energy signals to the device output. The devices will look fully identical. Randomization will be stratified by study site, pain diagnosis and sex of the patient. For each subject, after a screening phase of 1 week, patients will be treated for 3 weeks with a follow-up of additional 8 weeks, adding up to 12 weeks. During treatment patients will activate their device 3 times a day for 10 minutes each. During screening, treatment and follow-up period, all patients will twice per day report the average and maximum intensity of their pain Numeric Rating Scale (NRS). Patients will also enter the date, amount, and time of intake of rescue medication, if applicable. The primary objective of this study is to assess the impact on pain. Secondary objectives are to compare the performance between active therapy and sham, as well as to correlate changes in pain intensity with other pain related scales.

Начало: 25.05.2023 Край: 01.06.2027 Възраст: 18–99 г.

Austria, Switzerland Sobet AG NCT05851326

Набира участници Фаза 1

Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial

Malignant Glioma

This phase I trial finds out the possible benefits and/or side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.

Начало: 23.05.2023 Край: 15.09.2027 Възраст: от 18 г.

United States Mayo Clinic NCT05030298

Набира участници Фаза 1/2

FOG-001 in Locally Advanced or Metastatic Solid Tumors

Cancer Colorectal Cancer Solid Tumor Locally Advanced Solid Tumor +11

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.

Начало: 23.05.2023 Край: 31.08.2027 Възраст: от 18 г.

United States Parabilis Medicines, Inc. NCT05919264

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Randomized Assessment of TcMS for VT Storm

Ventricular Tachycardia

Three-arm randomized clinical trial comparing two strategies of TcMS to sham stimulation in patients with VT storm. The hypothesis of the study is that TcMS will reduce the burden of VT in the 24 hours after randomization compared to sham stimulation and that TcMS with theta burst stimulation (TBS) will be more effective at reducing VT burden than low frequency TcMS.

Начало: 22.05.2023 Край: 01.10.2028 Възраст: от 18 г.

United States University of Pennsylvania NCT05599022

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Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation

Cervical Spinal Cord Injury Tetraplegia

Cervical spinal cord stimulation can elicit arm and hand movements through recruitment of proprioceptive neurons in the dorsal roots. In participants with cervical spinal cord injury, the spare roots bellow the lesion can be used to reactivate motor function. Decoding of motor intentions can be achieved through implantable electrocorticography (ECoG) devices. In this study, the investigators will use an investigational system using ECoG signal recording over the motor cortex to drive muscle specific electrical epidural spinal cord stimulation (EES). The investigators will assess the safety and preliminary efficacy of this system in 3 participants.

Начало: 22.05.2023 Край: 31.12.2026 Възраст: 18–75 г.

Switzerland Ecole Polytechnique Fédérale de Lausanne NCT05665998

Набира участници Фаза 3

A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Myositis

The purpose of the study is to understand how the study medicine PF-06823859 (dazukibart) works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM. This study is seeking participants who: * Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater * Have active DM or active PM. * Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant. * Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body. Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position. Some of the participants will receive the study medicine (dazukibart) and some will receive placebo (which is similar to study medicine but contains no medicine in it). The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about 1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both dazukibart and placebo and will be given at the study site. The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if dazukibart is safe and effective. Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.

Начало: 20.05.2023 Край: 28.07.2027 Възраст: от 18 г.

Argentina, Bulgaria, China +17 Pfizer NCT05895786

Набира участници Фаза 2

A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to

ACUTE LYMPHOBLASTIC LEUKEMIA

This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and \

Начало: 17.05.2023 Край: 04.11.2036 Възраст: 1–17 г.

Austria, Belgium, Czechia +15 Pfizer NCT05748171

Набира участници Фаза 2

Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

Opioid-Related Disorders Mobile Applications Opiate Substitution Treatment Magnetic Resonance Imaging +3

The proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. In addition to standard app-based self-monitoring of drug use and personalized feedback, project innovation is enhanced by the proposed use of location-tracking technology for targeted, personalized intervention when participants enter self-identified areas of high risk for relapse. Furthermore, the proposed sub-study would use longitudinal functional neuroimaging to elucidate the brain-cognition relationships underlying individual differences in treatment outcomes, offering broad significance for understanding and enhancing the efficacy of this and other app-based interventions.

Начало: 16.05.2023 Край: 30.09.2028 Възраст: от 18 г.

United States University of Arkansas NCT05336188

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Evaluation of the SCALED (SCaling AcceptabLE cDs)

Traumatic Brain Injury Venous Thromboembolism

This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.

Начало: 16.05.2023 Край: 31.07.2026 Възраст: от 18 г.

United States University of Minnesota NCT05628207

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Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia

Alzheimer's Disease Dementia Brain Diseases Central Nervous System Diseases +4

The study tests the effect of the ATNC MDD-V1 on Alzheimer patients' cognitive function. The ATNC MDD-V1 uses non-invasive stimulation of both magnetic and cognitive training.

Начало: 15.05.2023 Край: 30.06.2027 Възраст: 60–85 г.

South Korea Advanced Technology & Communications NCT06088121

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Clinical Trial of Approaches to Prostate Cancer Surgery

Prostate Cancer

This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy. The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.

Начало: 15.05.2023 Край: 01.07.2028 Възраст: 40–80 г.

United States Weill Medical College of Cornell University NCT05155501

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Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC

Locally Advanced Esophageal Squamous Cell Carcinoma

This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks \[Q3W\]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery. Secondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.

Начало: 15.05.2023 Край: 31.12.2028 Възраст: 18–75 г.

China Shandong Provincial Hospital NCT07549100

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Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery

Breast Neoplasms

The most common complaints after breast surgery are postoperative pain reported in up to 68% of patients, musculoskeletal problems in the shoulder and functional limitations in up to 59% of patients after mastectomy and quadrantectomy, reduction in range of motion ( ROM) in 24-53% and strength deficit. The study aims to verify the effectiveness of a telerehabilitation treatment in terms of prevention of possible complications following breast cancer surgery. Primary objective: to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures. Secondary objective: to study any preoperative prognostic factors for the onset of complications, to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms, improvement of joint ROM, muscle strength and perceived quality of life.

Начало: 15.05.2023 Край: 30.07.2026 Възраст: от 18 г.

Italy Fondazione Policlinico Universitario Campus Bio-Medico NCT06608446

Набира участници Фаза 3

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

Начало: 11.05.2023 Край: 28.04.2031 Възраст: 5–60 г.

Canada, Puerto Rico, United States National Cancer Institute (NCI) NCT05675410

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Type 1 Diabetes Virtual Self-management Education and Support

type1diabetes

OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams. STUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario. INTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.

Начало: 10.05.2023 Край: 31.03.2027 Възраст: от 18 г.

Canada Unity Health Toronto NCT05756829

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