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NCT ID: NCT05033600 Completed - Clinical trials for Unspecified Trauma- and Stressor-Related Disorder

Pulsed ElectroMagnetic Field (PEMF) Therapy in Treating Post-Traumatic Stress Disorder (PTSD) & Trauma

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

Use of low-voltage, direct current pulsed electromagnetic fields (PEMF) in treating Post Traumatic Stress Disorder (PTSD), complex PTSD (cPTSD) and trauma-related injuries manifesting in physical and/or mental symptoms.

NCT ID: NCT05033080 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)

Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).

NCT ID: NCT05032833 Completed - Clinical trials for Pharmacokinetics in Healthy Adults

Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects

Start date: September 22, 2021
Phase: Phase 1
Study type: Interventional

The study will evaluate safety, tolerability and PK profile of 5-MeO-DMT in healthy subjects

NCT ID: NCT05032807 Completed - Clinical trials for Absorption; Chemicals

Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation

CLIP
Start date: July 1, 2022
Phase: Phase 1
Study type: Interventional

Cannabidiol (CBD) has been approved as a treatment for rare childhood epilepsies and could be an effective treatment for psychotic disorders, anxiety disorders and addictions. It is available as an oral liquid and as standard oral capsules. The bioavailability of oral cannabidiol is poor (only around 5-10% is absorbed), particularly in the fasted state. With food, its absorption is much higher. In one study, a high-fat breakfast increased the maximum plasma concentration by 4-5 times. As a result of this food effect, when prescribing standard oral formulations of CBD, clinicians should provide advice on dosing the drug according to mealtimes, otherwise, there may be an increased risk of side effects or limited effectiveness. One way to reduce the food effect and improve bioavailability is to use lipid excipients. In the present study, the investigators will evaluate CBD at the dose that is effective in patients with chronic psychosis (1000mg). The novel formulation will use lipids that are all EU pharmacopoeia approved and have been used in medicinal products before. The study aims to assess whether a novel lipid formulation can increase the bioavailability of oral CBD in the fasting state.

NCT ID: NCT05032339 Completed - Clinical trials for Plasma Cell Disorder

Evaluation of the Plasma Cell Disorders Panel on the BD FACSLyric™ Flow Cytometer

Start date: May 4, 2021
Phase:
Study type: Observational

Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.

NCT ID: NCT05032313 Completed - Clinical trials for Chronic Lymphoproliferative Diseases (CLPD)

Evaluation of the Chronic Lymphoproliferative Diseases Limited Panel on the BD FACSLyric™ Flow Cytometer

Start date: April 26, 2021
Phase:
Study type: Observational

Multi-site, prospective performance study to determine equivalency between the investigational CLPD Limited Panel on the FACSLyric system versus the final clinical diagnosis.

NCT ID: NCT05032157 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1- Antihistamines

REMIX-2
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

NCT ID: NCT05031559 Completed - Impulsive Behavior Clinical Trials

Episodic Future Thinking and Compassion

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

During the COVID-19 (Coronavirus Disease 2019) pandemic, public health departments have issued guidelines to limit viral transmission. In this environment, people will feel urges to engage in activities that violate these guidelines, but research on guideline adherence has been reliant on surveys asking people to self-report their typical behaviour, which may fail to capture these urges as they unfold. Guideline adherence could be improved through behaviour change interventions, but considering the wide range of behaviours that COVID-19 guidelines prescribe, there are few methods that allow observing changes of aggregate guideline adherence in the 'wild'. In order to administer interventions and to obtain contemporaneous data on a wide range of behaviours, the researchers use ecological momentary assessment. In this preregistered parallel randomised trial, 95 participants aged 18-65 from the United Kingdom were assigned to three conditions using blinded block randomisation, and engage in episodic future thinking (n = 33), compassion exercises (n = 31), or a sham procedure (n = 31) and report regularly on the intensity of their occurrent urges (min. 1, max. 10) and their ability to control them. The researchers investigate whether state impulsivity and vaccine attitudes predict guideline adherence, while assessing through which mechanism these predictors affect behaviour.

NCT ID: NCT05030584 Completed - Hot Flashes Clinical Trials

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause

OASIS-3
Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat women who have hot flashes after they have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo is a treatment that looks like a medicine but does not have any medicine in it. To compare these study treatments, the participants will record information about their hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe they are. They will study the results from before treatment and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants will take the study treatments for 52 weeks. During the study, the participants will visit their study site approximately 11 times and perform 2 visits by phone. Each participant will be in the study for approximately 62 weeks. During the study, the participants will: - record information about their hot flashes in an electronic diary - answer questions about their symptoms The doctors will: - check the participants' health - take blood samples - ask the participants questions about what medicines they are taking and if they are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05028673 Completed - Healthy Clinical Trials

A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants

Start date: August 23, 2021
Phase: Phase 1
Study type: Interventional

The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.