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NCT ID: NCT03106324 Active, not recruiting - Multiple Myeloma Clinical Trials

A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant

Start date: March 31, 2017
Phase:
Study type: Observational [Patient Registry]

This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.

NCT ID: NCT03105908 Completed - Chronic Pain Clinical Trials

Internet-delivered ACT for Chronic Pain

iACT
Start date: March 16, 2017
Phase: N/A
Study type: Interventional

The overall aim of the present study is to evaluate an internet-delivered Acceptance and Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the study will evaluate if 1) iACT is effective in improving functioning and quality of life in comparison to a waitlist condition, 2) if iACT is cost-effective, 3) factors that influence treatment outcome (i.e. predictors, moderators or characteristics of treatment responders), 4) if psychological variables mediates the effects of treatment on outcome, and 5) if subgroups of patients varies in change processes (i.e. moderated mediation). The main hypothesis is that iACT will improve functioning and quality of life.

NCT ID: NCT03105531 Completed - Hypertension Clinical Trials

Screening for Primary Aldosteronism in a Population of Patients With Hypertension

PRIMAL
Start date: April 7, 2017
Phase:
Study type: Observational

Primary aldosteronism (PA) is an under-diagnosed cause of arterial hypertension. Cardiovascular morbidity and mortality in hypertension rises significantly for patients who have aldosterone overproduction when compared with those with primary hypertension and the same level of blod pressure elevation. The classical signs of PA such as severe hypertension and hypokalemia may be absent, why screening in defined risk groups has been recommended. Screening has not been systematically implemented in Sweden, probably due to expensive, time and effort-consuming clinical routine protocols and low awareness of the problem among clinicians. The prevalence of PA in patients with hypertension in Sweden has not been studied adequately, and few studies from Northern Europe have addressed the problem. The primary objective is to investigate prevalence of PA among patients with hypertension in primary care and to implement and assess optimal treatment. Discovered cases of PA will go through routine clinical work-up in order to distinguish the subtype of PA, which includes computed tomography of adrenals and adrenal vein sampling (AVS) in those willing and fit for surgical treatment. Treatment will be then chosen depending on the PA subtype. Those with unilateral disease who are willing and fit for surgery will be offered unilateral minimally invasive adrenalectomy. Patients who oppose or have contraindications to operative treatment, as well as patients with bilateral disease will be offered medical treatment with mineralocorticoid receptor antagonists (MRA). Study participants will be then followed up one year after surgery or initiation of specific medical treatment. Please se outcome measures for relevant description of those. Blood samples will be collected from patients with confirmed PA to be stored in a biobank for potential future genetical and biochemical studies. A subgroup of patients with PA will undergo adrenal-specific positron-emission tomography to assess the possibility to un-invasively diagnose and subtype PA.

NCT ID: NCT03105375 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of X842 in Human: A Single/Multiple Ascending Dose Study

Start date: February 21, 2017
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to assess and analyze the safety, tolerability and PK/PD data following single ascending and multiple ascending doses of X842 in healthy subjects.

NCT ID: NCT03105128 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Start date: May 10, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

NCT ID: NCT03105102 Active, not recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

FORTIFY
Start date: April 9, 2018
Phase: Phase 3
Study type: Interventional

The study consists of 4 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; - Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. - OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

NCT ID: NCT03104764 Completed - Labial Tie Clinical Trials

Labial Frenulum Surgery - a Comparative Study of Conventional Scalpel and Er-Yag Laser Technique

Start date: August 1, 2014
Phase: N/A
Study type: Interventional

The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Wound healing was assessed five and ten days after after surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the study.

NCT ID: NCT03103542 Completed - Hemophilia A Clinical Trials

Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies

ReITIrate
Start date: August 29, 2017
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to describe the outcome of Immune Tolerance Induction (ITI) treatment performed with rFVIIIFc within a timeframe of 60 weeks in patients with haemophilia A who have failed previous attempts at tolerization.

NCT ID: NCT03102853 Completed - Obesity Clinical Trials

Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

Start date: August 15, 2016
Phase: N/A
Study type: Interventional

This project will examine whether long-term consumption of healthy Nordic foods can maintain a healthy weight also after weight loss, and decrease abdominal fat accumulation and cardiometabolic risk. The study will be performed with the aim to achieve a substantial body weight loss in the first phase by prescribing a standardized low caloric dietary formula. The follow-up phase will be a body weight-maintenance period and the subjects will be randomised to a healthy Nordic diet group and a control diet group. During the study body weight will be monitored and other measurements will include insulin sensitivity, blood lipids and inflammation markers.

NCT ID: NCT03101475 Completed - Colorectal Cancer Clinical Trials

Synergism of Immunomodulation and Tumor Ablation

ILOC
Start date: November 23, 2018
Phase: Phase 2
Study type: Interventional

This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patient with incurable liver metastases from colorectal cancer (CRC) (+/- limited extrahepatic disease) being stable or in partial remission after completion of 4-6 months first line systemic therapy. The primary objective of the study is to show an overall response rate of lesions not treated by ablation/radiotherapy including the extrahepatic lesions (according to iRECIST criteria) higher than 10%. With the continuation of first line systemic treatment, no further responses are expected. Secondary objectives are: - To establish the feasibility and safety of the combined treatment modalities; - To study the impact of the local technique (RFA/Radiotherapy) on the results; - To investigate biomarkers to predict response to the combined treatment