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NCT ID: NCT06052059 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

NCT ID: NCT06049875 Recruiting - Clinical trials for Home Hospitalization

Characteristics Associated With Duration of Home Hospitalization in Internal Department Versus Hospitalization in the Hospital in Internal Ward

ARC
Start date: July 2, 2023
Phase:
Study type: Observational

According to data from the OECD - Organization for Economic Co-operation and Development, the hospitalization crisis in Israel's hospitals is getting worse, both in relation to previous years in the State of Israel and in comparison to other countries [1]. There is an increase in life expectancy and the rate of aging of the population, which results in an increase in the number of beds in hospitals in relation to the growth rate of the population in need of treatment [2]. Furthermore, the government does not have the ability or an understandable plan for a significant and rapid increase in the number of hospital beds in the country. Instead, there is a recognition and a strategic decision by government officials in Israel, backed by the publication of relevant support tests [3], to develop hospitalization alternatives to hospital beds, primarily hospitalization within the community in the patient's natural environment, i.e. at home [4]. In a meta-analysis performed on patients with chronic diseases, it was found that the duration of treatment received by patients at home was 5.4 days longer compared to patients receiving treatment at the hospital, the risk of mortality was the same, re-hospitalization was lower among the patients hospitalized at home and the risk of worsening of the medical condition was smaller in 26 percent in hospitalization at home compared to hospitalization in the hospital [5]. For the patient receiving long-term care, it is extremely essential to be in a familiar and safe environment. Additional advantages to home hospitalization are a decrease in the chances of infection compared to the hospital and support from family members, both emotionally and physically [6]. Around the world, more and more experience is being accumulated in operating home hospitalizations as a substitute for hospitalization in a hospital. Comparative studies in diverse populations showed, already 20 years ago, that hospitalization at home is preferable to hospitalization in a hospital when it comes to the quality of life in a supportive and familiar environment [7]. However, the issue of the economic viability of home hospitalizations, whose cost was higher in the past, remains under question. There are studies that show a decrease in the cost of treatment in the home environment even in complex treatments and by professional teams [8]. Technological developments in the field of remote medicine have greatly contributed to improving the quality of care provided at home. Today, medical technology allows a patient who has been discharged from the hospital to be hospitalized at home, which allows the patient to continue to be treated at home through close medical and nursing supervision and advanced technological equipment. The technological development also allows cost reduction in different clinical settings such as: patients suffering from a flare-up of obstructive pulmonary disease [10,9], patients who are transferred to home hospitalization after surgery, elderly patients suffering from chronic diseases and needing hospitalization due to pneumonia and soft tissue infections, and patients suffering from exacerbation of heart failure [11]. The Ministry of Health and Welfare in the United States estimates that in 2030 one out of 5 Americans will be over the age of 65 and that home hospitalization is the preferred way to provide care to the patient as well as the optimal way in terms of costs [12]. This phenomenon will intensify the need for home hospitalization and will lead to improvements in the home sector [13]. At the Haim Sheba Tertiary Medical Center, they combine unique capabilities that make it particularly suitable for launching a home hospitalization service. The internal departments of the medical center are experienced in managing complex patients. The management of the departments is based on experts in internal medicine who have extensive experience in specializing in In the management of complex cases, with a high turnover of patients with mild and moderate degrees of severity, the hospital's position also matches the position of the relevant professional body - the Israeli Association of Internal Medicine - in regards to the launch of home hospitalization. A center for innovation in digital health was established in Sheba, the purpose of which is to test and implement advanced technologies of remote medicine. Examining and operating these technologies, while having a unique collaboration with the companies that develop and manufacture them, places the innovation in an excellent opening position in terms of the ability to evaluate and operate the existing technologies in the hands of the doctors in the medical center.

NCT ID: NCT06049784 Recruiting - Clinical trials for Obstetric Labor Complications

Prelabor Visual Biofeedback by a Self-operated Ultrasound Device

Start date: December 31, 2023
Phase: N/A
Study type: Interventional

A substantial number of women report fear of childbirth and negative birth experiences. The objective of the study is to assess the efficacy of visual biofeedback before labor using a self-operated home ultrasound for maternal pushing training, which is expected to reduce fear of childbirth, increase perceived control during birth, prevent prolonged labor and the ensuing maternal and neonatal negative adverse outcomes, and prevent maternal post-traumatic stress symptoms. Intrapartum visual biofeedback provided by obstetricians during the second stage of labor has been shown to increase pushing efficiency and improve maternal obstetric and psychological outcomes. Previously, visual biofeedback has been implemented only in an in-hospital setting and, with one known exception, only during labor. A Mobile Self-Operated Home Ultrasound System has been reported as a feasible and reliable tool for obstetrical ultrasound. A randomized controlled trial will be conducted with three study groups of pregnant women (37-39 weeks of gestation): (1) Obstetrical ultrasound+visual biofeedback in-hospital and at home using self-operated ultrasound; (2) Obstetrical ultrasound+visual biofeedback in-hospital; (3) Obstetrical ultrasound only. Visual biofeedback by ultrasound will be performed by transperineal ultrasound, enabling the future mother to visualize the descent of the fetal head within the birth canal in response to her pushing effort. Follow-up will be conducted two weeks later and at six weeks postpartum. Positive results following the application of biofeedback by self-operated home ultrasound may change the paradigm for pre-labour sonographic education. Self-operated home ultrasound will also enable more comprehensive pre-labor ultrasound-based education and hopefully reduce adverse physical and psychological outcomes following childbirth.

NCT ID: NCT06045806 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06037902 Recruiting - Esophageal Cancer Clinical Trials

CPAP for Esophageal Cancer With Radiotherapy

TROS-7
Start date: August 21, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the use of CPAP in patients with esophgaeal cancer undergoing radiotherapy. The main questions it aims to answer are: - does use of CPAP decrease exposure of normal lung to radiation? - does use of CPAP decrease exposure of normal heart to radiation? Participants will undergo simulation twice: - with CPAP - without CPAP

NCT ID: NCT06037252 Recruiting - Obesity Clinical Trials

A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

Start date: September 21, 2023
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

NCT ID: NCT06034743 Recruiting - Clinical trials for Resistant Hypertension

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

BaxHTN
Start date: November 22, 2023
Phase: Phase 3
Study type: Interventional

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 once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

NCT ID: NCT06032312 Recruiting - Obesity Clinical Trials

Metabolically Healthy Obese

MHO
Start date: December 1, 2020
Phase:
Study type: Observational

Little is known about the associated factors and mechanisms involved in the development of metabolic disturbance in pediatric obesity. The overall objective of the present study is to investigate clinical, anthropometric, socio-demographic and lifestyle predictors of MHO among obese children and adolescents. The Aim of the present study is to investigate the effect of fat distribution, muscle mass, strength and physical activity level on metabolic morbidity in obese adolescents.

NCT ID: NCT06030830 Recruiting - Breastfeeding Clinical Trials

SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

SMaRT
Start date: June 6, 2023
Phase: N/A
Study type: Interventional

In the last decade, infants are born into a social environment in which the smartphone has become an essential part of our lives. Smartphone use draws the mother's attention during mother-infant interactions and thus may affect the infant development as well as maternal self-efficacy. However, the effects of smartphone use reduction among breastfeeding mothers during their interactions with their infants have not been studied yet. In the present study, we propose to evaluate a "SMaRT Mom" intervention that we have developed, to manage and reduce smartphone use during breastfeeding. The purpose of the study is to evaluate the effects of the SMaRT Mom intervention on breastfeeding mothers' biobehavioral mechanisms, self-efficacy and the socioemotional characteristics of their infants. This will extend our knowledge of the peculiarities of early mother-infant interactions in the digital era, when smartphones play a critical role.

NCT ID: NCT06029361 Recruiting - Hip Fractures Clinical Trials

Improvement of Function After Hip Fracture in Geriatric Rehabilitation Unit Via Augmented Reality Device "SELFIT"

Start date: August 8, 2023
Phase: N/A
Study type: Interventional

Type of study: prospective interventional the purposes of the research :To examine the effect of treatment using the SELFIT system on function, walking and balance in patients after hip fractures hospitalized in the geriatric rehabilitation department. The study population: 50 participants aged 65+ who were admitted to the geriatric rehabilitation department after hip fractures, with 25 in the experimental group and 25 in the control group. The main question[s] it aims to answer are: - What is the effect of training with SELFIT system on the functional outcomes in patients after hip fractures hospitalized in the geriatric rehabilitation department. - How the training with SELFIT system will effect on satisfaction of the patients in the geriatric rehabilitation department. During 21 days, both groups will receive physical therapy for about 45 minutes. The experimental group will be allocated about 15 minutes out of the 45 minutes to practice with the help of the SELFIT system.