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NCT ID: NCT05102526 Enrolling by invitation - Primary Prevention Clinical Trials

Increasing the Impact of a School Prevention Program Among Young Adolescents by Adding a Teacher Component

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

A randomized clinical trial in clusters, including the development and implementation of an intervention program among young adolescents and their teachers. The research hypothesis is that the intervention program will yield improvement in adolescents whose parents participated in the program, compared with adolescents whose teachers were not involved in the intervention. The results will be measured using the research questionnaire, which participants will complete before, after and three months after the end of the program. The questionnaire will include approved questionnaires with good psychometric properties. In addition, there will be a quality interview. The study protocol was approved by the Tel Hai College Institutional Audit Committee. Parents of all participants in the intervention and control group as well as the teachers involved in the program received information about the program and research and were asked to give informed consent.

NCT ID: NCT05066282 Enrolling by invitation - PTSD Clinical Trials

Long-Term Safety and Effectiveness of MDMA-Assisted Therapy for PTSD

MPLONG
Start date: March 1, 2021
Phase:
Study type: Observational

Data from a series of Phase 2 and 3 studies of MDMA-assisted therapy conducted by the sponsor provide preliminary evidence that chronic Posttraumatic Stress Disorder (PTSD), independent of cause, is treatable with up to three sessions of MDMA-assisted therapy. This non-interventional study will serve as the long-term follow-up (LTFU) protocol for MDMA-assisted therapy clinical trials and will measure persistence of effectiveness using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as a measure of PTSD symptom severity. Additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. Participants who have received at least one dose of Investigational Medicinal Product (IMP) in the main study will be eligible to participate in this study.

NCT ID: NCT05041309 Enrolling by invitation - Clinical trials for Solid and Hematological Malignancies

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

NCT ID: NCT04957719 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

SOS-AMI
Start date: August 14, 2021
Phase: Phase 3
Study type: Interventional

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

NCT ID: NCT04938271 Enrolling by invitation - Clinical trials for Osteoarthritis, Knee

A Telehealth Study of a Wearable Electroceutical & Sports Sleeve for Knee Osteoarthritis Pain Relief & Improved Function

HEAL01WMCOA1
Start date: November 22, 2021
Phase: N/A
Study type: Interventional

The purpose of this telemedicine 24-person open-label study is to evaluate the safety and usability of a proprietary wearable microcurrent electroceutical (a device that delivers micro-ampere electronic pulses) made by Healables, Ltd. to promote healing of chronic mild to moderate knee osteoarthritis as shown by decreased disability and relief of pain. In this study, subjects treat themselves at home once/day for an hour using a smart phone to activate the device worn on an e-textile sports knee sleeve. Microcurrent signals are transmitted from a device thru built in conductive pathways to strategic electrodes placed above and below the knee. A proprietary App both activates therapeutic protocols to transmit microcurrent signals as well as allows user-generated recording of the status of knee pain & function prior to and following each treatment. These records are then transmitted to health professionals using software compliant with human use data transmission regulations including subject anonymity. The rationale that the device would be effective is supported by microcurrent treatment for osteoarthritis at several US clinics including the prestigious Cleveland Clinic as well as by data of published randomized controlled clinical trials. One reason that more persons do not avail themselves of microcurrent therapy is that treatment usually requires several trips to a clinic often requiring considerable travel by a patient who may be in considerable pain. The health provider typically administers therapy in a clinic using electrodes with a desktop sized instrument. Our miniaturization of a microcurrent device and its use with wearable e-textiles such as a knee compression sleeve is a distinct advantage that enables regular use of effective therapy in home-based self-treatment to provide pain relief and improved knee function. Microcurrent electrotherapy represents a significant improvement in pain control and healing since it employs current in the microampere range, 1000 times less than that of Transcutaneous Electrical Nerve Stimulator (TENS) devices that transmit millicurrent electrical signals. This study is designed to demonstrate use of a wearable microcurrent electroceutical at home for subjects to self-treat at their leisure in a comfortable environment that facilitates healing. Moreover, data communication via a smart phone App to health providers enables digital telemedicine for rapid collation and interpretation of relevant data.

NCT ID: NCT04905693 Enrolling by invitation - Clinical trials for Idiopathic Pulmonary Fibrosis

Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

TETON-OLE
Start date: September 6, 2022
Phase: Phase 3
Study type: Interventional

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis.

NCT ID: NCT04848506 Enrolling by invitation - Clinical trials for Symptomatic Hypertrophic Cardiomyopathy (HCM)

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

FOREST-HCM
Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

NCT ID: NCT04798430 Enrolling by invitation - Clinical trials for Familial Hypercholesterolemia

Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction

LIBerate-OLE
Start date: December 3, 2020
Phase: Phase 3
Study type: Interventional

The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [<31 days]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.

NCT ID: NCT04760769 Enrolling by invitation - Parkinson Disease Clinical Trials

Open-label Trial in Parkinson's Disease (PD)

TEMPO-4
Start date: February 24, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.

NCT ID: NCT04688619 Enrolling by invitation - Primary Prevention Clinical Trials

Adolescents as Change Agents in the Incorporation of a Parental Component for a School Based Prevention Program

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their parents. Adolescents will be the "change agents" and will receive activities and assignments to complete together with their parents, as a mean for increasing parental involvement in the program. Study hypothesis is that the intervention program will yield improvement in adolescents whose parents participated in the program, in comparison with the adolescents whose parents weren't involved in the intervention. Results will be measured using the study questionnaire, to be filled out by the participants before, immediately after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. The study protocol was approved by Tel Hai College institutional review board. Parents of all participants, in the intervention and in the control group, received information about the program and the study and were asked to provide informed consent.