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NCT ID: NCT06050967 Completed - Clinical trials for Gaucher Disease Type 1

A Second-generation AI Based Therapeutic Regimen in Patients With Gaucher Disease Treated With Enzyme Replacement Therapy.

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

An open-labeled, prospective, single-center proof-of-concept study. Patients with Gaucher Disease aged 18-75 who received intravenous Enzyme Replacement Therapy once every two weeks were enrolled. The study utilized the Altus Careā„¢ cellular phone-based application, which integrated an algorithm-based approach to provide random dosing regimens within a pre-defined range determined by the physician. The app allowed personalized therapeutic regimens with variations in dosages and administration times.

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: NCT06049745 Not yet recruiting - Clinical trials for Hysteroscopic Myomectomy

Use of Misoprostol in Hysteroscopic Myomectomy

Start date: November 2023
Phase: Phase 4
Study type: Interventional

Hysteroscopic myomectomy is typically suitable for myomas measuring under 4 cm in size. The utilization of misoprostol before the procedure can facilitate uterine access, decrease fluid absorption, and reduce blood loss, consequently leading to a decrease in the overall procedure time. In this randomized trial, the investigators aim to investigate the impact of misoprostol administration and its effects on each of the mentioned parameters.

NCT ID: NCT06046534 Completed - Clinical trials for Systemic Lupus Erythematosus

Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.

ERYTHRO
Start date: October 27, 2023
Phase:
Study type: Observational

The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.

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: NCT06045507 Active, not recruiting - HIV Clinical Trials

Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)

Start date: November 8, 2023
Phase: Phase 2
Study type: Interventional

This double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.

NCT ID: NCT06044467 Completed - Clinical trials for Nonalcoholic Fatty Liver Disease

The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects

Start date: December 11, 2018
Phase: Phase 1
Study type: Interventional

A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) < 3 that are in general good health and have normal liver functions to be treated with CM-101.

NCT ID: NCT06041906 Enrolling by invitation - Clinical trials for Congenital Porto-Systemic Shunt (CPSS)

International Registry of Congenital Portosystemic Shunt (IRCPSS)

IRCPSS
Start date: April 26, 2018
Phase:
Study type: Observational [Patient Registry]

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

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