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NCT ID: NCT04175457 Completed - Thrombosis Clinical Trials

The Acute Effects of E-cigarette Inhalation on Vascular Function, Microcirculation and Thrombosis

Start date: December 5, 2019
Phase: N/A
Study type: Interventional

This is a human randomized controlled cross-over study where the effects of e-cigarette inhalation (with or without nicotine) on vascular function, microcirculation and thrombosis is assessed.

NCT ID: NCT04175366 Recruiting - Psychosis Clinical Trials

Shared Decision Making in Psychiatric Inpatient Care

DEAL
Start date: December 10, 2019
Phase: N/A
Study type: Interventional

Introduction National guidelines and The Patient Act from 2014 call for an active role for the patient in the decision making process. The role of the doctor is not only to give advice and to prescribe treatments, but also to present different alternatives with pros and cons. The method of Shared Decision Making (SDM) is meant to improve patient participation in line with ethical guidelines and legal demands. In summary, SDM consists of three steps: 1. To introduce a choice. 2. To discuss the options. 3. To make a shared decision. Systematic studies on SDM show patients becoming better informed and less uncertain regarding decisions made, and decisions closer to clinical guidelines compared to treatment as usual (TAU). It is still unresolved if SDM leads to improved clinical outcomes. Aim The aim of the study is to investigate outcomes of SDM carried out in psychiatric inpatient care: the patients' perceived participation (primary outcome) and health related outcomes (secondary). Method The decision situation in focus for this project is the planning of hospital discharge and future outpatient care. The participants are randomized to either SDM or TAU. Patient participation will be measured by questionnaires, interviews with patients and recorded decision talks. Clinical outcomes will be measured 12 months after discharge. Preliminary results A pilot study conducted in 2017-2018 clarified the feasibility of instruments and the intervention, and gave data for power estimation.

NCT ID: NCT04175132 Terminated - Healthy Clinical Trials

Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)

Start date: November 12, 2019
Phase: Phase 1
Study type: Interventional

A study to learn how foliglurax binds in regions of the brain

NCT ID: NCT04174118 Completed - Clinical trials for Alpha 1-Antitrypsin Deficiency

Study of DCR-A1AT in Healthy Adult Volunteers

Start date: October 24, 2019
Phase: Phase 1
Study type: Interventional

This is a research study to test an experimental study drug (belcesiran, also known as DCR-A1AT). This drug is being tested to see if it helps people with a rare condition known as Alpha-1 Antitrypsin Deficiency, or A1ATD. Prior to initiation of this study belcesiran had not yet been tested in humans. All study participants will be randomly assigned to either receive the study drug or a placebo. This will allow for the sponsor to compare the effects of the study drug with that of the placebo. A placebo looks like the study drug but does not contain any of the study drug. The main purpose of the first part of the study is to evaluate the safety profile of the study drug in people who do not have A1ATD. This part of the study will also help find the dose of the study drug that has an acceptable safety profile for testing.

NCT ID: NCT04173494 Completed - Clinical trials for Primary Myelofibrosis

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)

Start date: February 7, 2020
Phase: Phase 3
Study type: Interventional

MOMENTUM is a randomized, double-blind, active control Phase 3 trial intended to confirm the differentiated clinical benefits of the investigational drug momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic participants who have previously received an approved Janus kinase inhibitor (JAKi) therapy for myelofibrosis (MF). The purpose of this clinical study is to compare the effectiveness and safety of MMB to DAN in treating and reducing: 1) disease related symptoms, 2) the need for blood transfusions and 3) splenomegaly, in adults with primary MF, post-polycythemia vera MF or post-essential thrombocythemia MF. The study is planned in countries including, but not limited to: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Romania, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom (UK) and United States (US). Participants must be symptomatic with a Myelofibrosis Symptom Assessment Form (MFSAF) version (v) 4.0 Total Symptom Score of >= 10 at screening, and be anemic with hemoglobin (Hgb) < 10 gram/deciliter (g/dL). For participants with ongoing JAKi therapy at screening, JAKi therapy must be tapered over a period of at least 1 week, followed by a 2-week non-treatment washout interval prior to randomization. Participants will be randomized 2:1 to orally self-administer blinded treatment: MMB plus placebo or DAN plus placebo. Participants randomized to receive MMB who complete the randomized treatment period to the end of Week 24 may continue to receive MMB in the open-label extended treatment period to the end of Week 204 (a total period of treatment of approximately 4 years) if the participants tolerates and continues to benefit from MMB. Participants randomized to receive DAN may cross-over to MMB open-label treatment in the following circumstances: at the end of Week 24 if they complete the randomized treatment period; or at the end of Week 24 if they discontinue treatment with DAN but continue study assessments and do not receive prohibited medications including alternative active anti-MF therapy; or at any time during the randomized treatment period if they meet the protocol-defined criteria for radiographically confirmed symptomatic splenic progression. Participants randomized to receive DAN who are receiving clinical benefit at the end of Week 24 may choose to continue DAN therapy up to Week 48. The comparator treatment, DAN, is an approved medication in the US and in some other countries and is recommended by national guidelines as a treatment for anemia in MF.

NCT ID: NCT04173377 Recruiting - Orthopedic Disorder Clinical Trials

Elbow Outcomes Clinical Study (WELBOW)

WELBOW
Start date: June 8, 2020
Phase:
Study type: Observational

WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).

NCT ID: NCT04173013 No longer available - Clinical trials for Urinary Tract Infections

Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

Start date: n/a
Phase:
Study type: Expanded Access

An Expanded Access Program for UROMUNE® for patients suffering from recurrent/chronic urinary tract infections of diverse etiology. This is for individuals for whom antibiotic therapy has failed, but of consideration in all cases, taking into account antibiotic-induced adverse reactions and increasing antibiotic resistance.

NCT ID: NCT04172610 Completed - Influenza, Human Clinical Trials

Prevalence of Influenza RelAted Invasive Aspergillosis

PIRAIA
Start date: December 2, 2019
Phase:
Study type: Observational

This is a multicenter study with the aim to determine the prevalence of influenza-related invasive pulmonary aspergillosis in Swedish intensive care units and to assess the clinical impact of and risk factors for influenza-related invasive pulmonary aspergillosis

NCT ID: NCT04170283 Recruiting - B-cell Malignancies Clinical Trials

Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

Start date: January 21, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.

NCT ID: NCT04169789 Completed - Clinical trials for Postmenopausal Osteoporosis

Prevention of Early Postmenopausal Bone Loss With Lactobacillus Reuteri

ELBOWII
Start date: December 4, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effect of two different doses of Lactobacillus reuteri ATCC PTA 6475 (L.reuteri 6475) on bone loss in early postmenopausal women. One third of the participants will be randomised to the lower dose, one third to the higher dose and one third to placebo.