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NCT ID: NCT04176523 Recruiting - Propionic Acidemia Clinical Trials

Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approach

PROTECT
Start date: January 15, 2019
Phase:
Study type: Observational

This is a prospective mixed-design study focused on the long-term management of propionic aciduria (PA) and methylmalonic aciduria (MMA) with N-carbamylglutamate (NCG) maintenance therapy. Treatment characteristics, clinical outcomes, and healthcare utilization data of patients diagnosed PA or MMA treated >6 months therapy with NCG are collected at baseline, 12 months, 18 months, 36 months and 54 months. Qualitative interviews with adult patients and caregivers are conducted >6 months after study enrollment to gain a better understanding of the disease burden and the treatment burden of patients and their families.

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04173156 Completed - Clinical trials for Periodontal Diseases

Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

40 patients diagnosed with localised periodontitis will be included at each center, 20 patients will be treated with the control treatment, 20 patients will be treated by test treatment.

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: NCT04172662 Completed - Anxiety Clinical Trials

Music Therapy as an Adjunct in CIED Lead Extraction Procedures

MATH
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.

NCT ID: NCT04171128 Completed - Influenza Clinical Trials

Procalcitonin Role in Influenza Patients With Regard to Morbidity, Mortality and Antibiotic Use

Start date: February 2, 2019
Phase:
Study type: Observational

The investigators intend to observe the inflammatory marker procalcitonin (PCT) in comparison with patient variables on morbidity, mortality and antibiotic treatment. The overall aim is to observe if a low PCT value can have potential in reducing unessesary antibiotic use in seasonal influenza patients.

NCT ID: NCT04167904 Completed - Clinical trials for Myocardial Infarction, Acute

Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction

BIOMAC
Start date: January 15, 2020
Phase:
Study type: Observational

The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. The primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin I in diagnosing acute myocardial infarction.

NCT ID: NCT04164940 Recruiting - Alcohol Dependence Clinical Trials

Patient Trajectories for Older Adults Admitted to Hospital for Alcohol-related Problems

Start date: October 23, 2019
Phase:
Study type: Observational [Patient Registry]

Alcohol is contributing to many health problems and disorders, as well as accidents and social problems. Alcohol consumption has been on the rise the past 25 years, especially in Norway. The highest increase is found in older adults, in line with the development in most other countries in the western world. Older adults have a higher risk for alcohol related health problems, due to age related physiological changes, medical conditions and medications. Still, alcohol use is seldom addressed for older people. This means that older people rarely receive help to change alcohol habits. Norwegian health authorities have issued mandates ordering the regional health trusts to implement strategies in somatic hospital wards, mental health services and drug treatment services to identify and treat alcohol and drug problems affecting the patients' health. In this observational study we will explore patient trajectories three years prior to and three years after an admittance to hospital where risky or harmful alcohol consumption is identified and brief interventions are delivered. Hospitals that have implemented such strategies are invited to the study. Patient trajectories are studied in national health registries. This will provide important knowledge on what characterizes the patients identified, and what happens after they have received a brief intervention related to a hospital admittance.

NCT ID: NCT04164849 Completed - Crohn Disease Clinical Trials

Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid

Start date: November 22, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

In the clinical trial the investigators will assess efficacy, safety and tolerability after single and multiple doses of 3 millimolar 5 aminolevulinic acid (Gliolan®) in combination with blue-light (405 nanometer) photopheresis in patients with active crohns disease. The study is a proof-of-concept pilot with up to 10 included patients where every patient will get active treatment. The use of 5-aminolevulinic acid in combination with blue-light photopheresis is a first-in-human trial. Primary endpoints include clinical response and adverse events (safety). Secondary endpoints include endoscopic improvement, quality of life questionnaires, faecal calprotectin, C-reactive protein and mechanisms of action (differences in t-cells and other cells before and after treatment). All patients will get treatment every 2 weeks for 10 weeks (6 treatments-induction) with evaluation at week 13. If any effect on week 13 eligible for study extension with treatment every 4 weeks for up to 12 months for the first 5 patients. The latter 5 patients will be referred to standard of care on the week 13 visit. Through the study the investigators will see if this kind of photopheresis is safe and can be an option for a larger randomized-controlled-trial. In addition the investigators will see if photopheresis as an option can be further developed for other diseases as well (ie other T-cell mediated diseases or patients already receiving photopheresis as a treatment).

NCT ID: NCT04163107 Completed - Multiple Myeloma Clinical Trials

Combined Carfilzomib and Hydroxychloroquine in Patients With Relapsed/Refractory Multiple Myeloma

MYELOMA-HCQ
Start date: January 7, 2020
Phase: Phase 1
Study type: Interventional

Multiple myeloma (MM) is a neoplastic expansion of bone marrow plasma cells. Despite advances in treatment in recent years, MM is still a fatal disease. MM is characterized by the ability of malignant cells to produce large amounts of monoclonal immunoglobulin. The secretion of these immunoglobulins can be detected as the "M-protein" in serum, and the measurement of the M-component is used both for diagnosis and to evaluate treatment response and relapse. The high load of secreted proteins in MM cells requires a efficient way to clear these proteins from the cells and targeting protein degradation is an important therapeutic target in MM. This is today done by inhibiting the proteasome, one of the two central ways cells can degrade proteins, by drugs named proteasome inhibitors (including bortezomib, ixazomib and carfilzomib). Patients become resistant to these drugs, and it is therefore likely that myeloma cells also utilise another important system for protein degradation, called autophagy. Pre-clinical studies have shown that the combination of the proteasome inhibitor carfilzomib and the autophagy inhibitor hydroxychloroquine increases myeloma cell death and that hydroxychloroquine is able to reverse MM cell resistance to carfilzomib. This is the rationale for this study, where the investigators add the autophagy inhibitor hydroxychloroquine to a standard regime of carfilzomib and dexamethasone, to determine a maximum tolerated dose of this combination and to study tolerability.