Clinical Trials Logo

Filter by:
NCT ID: NCT05046418 Active, not recruiting - Cows Milk Allergy Clinical Trials

Synbiotics Cohort Study

Start date: September 5, 2021
Phase:
Study type: Observational

Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.

NCT ID: NCT05045924 Active, not recruiting - Clinical trials for Decompensated Cirrhosis

CirrhoCare in COVID-19: A Pilot, Remote, Home Monitoring Study in Advanced Cirrhosis

Start date: June 1, 2021
Phase:
Study type: Observational

The COVID-19 outbreak has exposed many strengths and weaknesses of delivering healthcare, and we want to assess whether patients with advanced liver cirrhosis can be effectively monitored at home, to limit hospital visits and thereby their infection risks. We also wish to show that if they have new signs of clinical deterioration, that these can be picked up quickly even in the community, and can result in early review or appropriate treatment. This study has been funded by INNOVATE UK, who are seeking novel ways and technologies to improve health during the pressures of the COVID pandemic. Taking part in this study involves a consultation with the investigating doctor and being shown how to use a phone-based App and the supplied CirrhoCare equipment (Withings Watch, scales, and Blood Pressure cuff). Patients will be shown how to use the equipment for several simple daily assessments, including: Heart rate (ECG) readings via the supplied Withings Watch. This would take approximately 7-10 minutes to perform each day. Daily weight, using a special weighing scale that also measures the amount of body water and muscle percentages (takes 30 seconds to perform). Digital blood pressure measurement, using the supplied cuff. This would take approximately 2 minutes to perform daily. For all the above measurements, that are entirely automated, the patient will be guided via the mobile phone App with step-by-step video instructions. In addition, they will be given printed instructions. Individuals will be asked to perform the measurements through daily prompts built into the App, and be sent reminders, in case they forget. If they have difficulties with any of the tasks, there is also an App based support system, where they can send a message for the trial team to provide assistance. In addition to the measurements above, patients will be prompted to click on a memory testing exercise of naming animals (termed - 'Stroop test'), which will be performed after the daily morning measurements. This can take half a minute to up to four minutes to perform, depending on an individual's memory function. The equipment will be supplied will enable daily monitoring for a maximum of 3 months in this study. We will also be able to learn from the supplied watch, how much sleep and how much daily exercise patients get, which will help us assess general physical well-being. Furthermore, patients will be aksed to supply information on the amount of fluid and food they have consumed via simple 'click' functions on the App (e.g. clicking next to the picture denoting 4 glasses of water). Patients will be prompted to do this via smartphone and watch every evening. We will seek patient feedback on using the App through a brief in-App based questionnaire, after 4, 8 and 12 weeks of study. In addition, patients will fill in a quality of life questionnaire before they start using the equipment, and then again after 4 weeks and 12 weeks. These brief questionnaires are through simple drop-down menus on the App and take less than 5 minutes to complete. At the end of 12 weeks, or if individuals leave the study earlier, all the equipment will be returned to the investigating team, to analyse the data. In addition to the data that we will collect from the digital tools described above, we will also access routine blood tests performed when determined necessary by the liver doctors, as part of the standard of care.

NCT ID: NCT05038228 Active, not recruiting - Atrial Fibrillation Clinical Trials

High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France

HELIOS-AF
Start date: August 1, 2022
Phase:
Study type: Observational

This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with NVAF with high risk of gastrointestinal bleed who initiate anticoagulant treatment with a Vitamin-K Antagonists (VKAs) or direct-acting oral anticoagulants (DOACs).

NCT ID: NCT05037929 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Start date: October 5, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

NCT ID: NCT05036135 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)

IMPAHCT
Start date: December 2, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

IMPAHCT: Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial is a Phase 2b/Phase 3 study to evaluate the safety and efficacy of AV-101 (dry powder inhaled imatinib) in patients with Pulmonary Arterial Hypertension (PAH). The Phase 2b part of the study will assess three doses to establish an optimal dose for the Phase 3 part of the study. The Phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (PVR). The Phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6MWD) after 24 weeks of treatment.

NCT ID: NCT05035030 Active, not recruiting - Alagille Syndrome Clinical Trials

Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

ASSERT-EXT
Start date: September 3, 2021
Phase: Phase 3
Study type: Interventional

An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)

NCT ID: NCT05032066 Active, not recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis

Start date: August 25, 2021
Phase: Phase 2
Study type: Interventional

HZNP-HZN-825-303 (HARBOR) comprises of 2 parts. Part 1 (Core Phase) is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in participants with Idiopathic Pulmonary Fibrosis (IPF). Part 2 (Extension Phase) is an optional, open-label, repeat-dose, multicenter extension of the Core Phase. The trial will include up to an 8-week Screening Period and a 52-week Double-blind Treatment Period in the Core Phase and 52 weeks of open-label HZN-825 treatment in the Extension Phase. During the Core Phase, participants will be screened within 8 weeks prior to the baseline (Day 1) Visit. Approximately 135 participants who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally for 52 weeks using the following 2 stratification factors: 1. Concomitant use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no 2. Forced vital capacity (FVC) % predicted at Baseline: ≥70% or <70% Participants who complete the 52-week Double blind Treatment Period of the Core Phase of the trial will be invited to extend their participation in the 52-week Extension Phase of the trial.

NCT ID: NCT05030831 Active, not recruiting - Clinical trials for Pseudoxanthoma Elasticum

Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ABCC6 Deficiency Causing PXE

Start date: April 11, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics PD) of multiple ascending doses of INZ-701, an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) recombinant fusion protein, for the treatment of ABCC6 Deficiency. The goal of the study is to identify a dose regimen for further clinical development in the treatment of ABCC6 Deficiency.

NCT ID: NCT05028569 Active, not recruiting - Episodic Migraine Clinical Trials

Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Start date: November 5, 2021
Phase: Phase 3
Study type: Interventional

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (ICHD 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM. BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world. Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Week 0 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05028179 Active, not recruiting - Clinical trials for Coronary Heart Disease

PROTEUS: Evaluating the Use of Artificial Intelligence to Support Stress Echocardiography Testing for Heart Disease

PROTEUS
Start date: November 8, 2021
Phase: N/A
Study type: Interventional

PROTEUS is a multicentre, two arm, randomised controlled trial of a medical device to assess the impact of the introduction of EchoGo into the standard care pathway for stress echocardiology.