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NCT ID: NCT02572960 Completed - Osteoporosis Clinical Trials

Physiologic Interactions Between the Adrenal- and the Parathyroid Glands

AldOst
Start date: October 2015
Phase: Phase 4
Study type: Interventional

To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.

NCT ID: NCT02572271 Completed - Weight Loss Clinical Trials

Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two different techniques of mastopexy with autologous augmentation, the Lower Pole Subglandular Advancement Mastoplasty (LOPOSAM) and Rubins Mastopexy with autologous augmentation, in massive weight loss patients to see if one technique is superior to the other.

NCT ID: NCT02572115 Completed - After-hours Care Clinical Trials

Differentiated Access to Out-of-hours Primary Care Through Emergency Access

Akutknappen
Start date: September 4, 2017
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial is to test the use of an emergency button that allows patients to jump the telephone waiting line at the out-of-hours primary care in two regions in Denmark if they perceive their illness as acute and severe.

NCT ID: NCT02572024 Completed - Clinical trials for Resistant Hypertension

The Effect of BATon BP and Sympathetic Function in Resistant Hypertension (The Nordic BAT Study)

BAT
Start date: November 2015
Phase: N/A
Study type: Interventional

Resistant hypertension (RH) affects some 10% to 15% of all patients with hypertension. These patients are at a clearly increased risk for end organ damage and mortality. Furthermore, arterial hypertension is a multifactorial disease including genetic, lifestyle, dietary, metabolic, and sympathetic factors. However, the current treatment modalities have not been optimal in targeting the compensatory changes in sympathetic nervous system function and new strategies have been warranted. Baroreflex activation therapy (BAT) is a special treatment option for some patients with RH that modulates the autonomic nervous system to restore sympathovagal balance. Notably, in BAT both long-term safety and efficacy in a large-scale, randomized, double blind, controlled trial has been shown. However, the trial design and BAT methodology resulted in that the first generation Rheos® system did not achieve the prespecified endpoints for short-term safety and efficacy. Notably, a second-generation minimally invasive BAT system (Barostim Neo®) has now been developed to address these limitations although randomized, double blind, controlled clinical trials are still lacking. Noteworthy, in the recent European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines for the management of arterial hypertension, carotid baroreceptor stimulation is mentioned as one of the options to treat resistant hypertension. Based on these data the aim of this randomized, double-blind, parallel-design clinical trial is to examine the effect of BAT compared to continuous pharmacotherapy on blood pressure, as well as arterial and cardiac function and structure using non-invasive high technology methodology, in a Nordic multicentre study. This study will include 100 patients with RH (20 from Helsinki). Eligible patients are between 18 and 70 years and have a daytime systolic ambulatory blood pressure 145 mmHg or more, and/or a daytime diastolic ambulatory blood pressure of 95 mmHg or more, after witnessed intake of antihypertensive treatment (including at least 3 antihypertensive drugs preferably including a diuretic), with no changes in medication for a minimum of 4 weeks prior to enrolment. Patients with severe renal insufficiency, type 1 diabetes, psychiatric illness, severe cardiovascular disease, or any complication that is a risk to the planned surgery are exclusion criteria. The primary end point is to test whether BAT reduces 24-hour systolic ambulatory blood pressure at 8 months of follow-up compared to continuous pharmacotherapy. Secondary end points are to test whether BAT reduces home blood pressure during follow-up compared to continuous pharmacotherapy, whether BAT reduces office blood pressure during follow-up compared to continuous pharmacotherapy, and the effect of BAT on autonomic function measured as eg. baroreflex sensitivity and heart rate variability.

NCT ID: NCT02571777 Completed - Asthma Clinical Trials

Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

Start date: December 8, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

NCT ID: NCT02571361 Completed - Pain, Postoperative Clinical Trials

PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial

PANSAID
Start date: November 2015
Phase: Phase 4
Study type: Interventional

Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial Trial acronym: PANSAID Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy. Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA. Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg. Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians. Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.

NCT ID: NCT02569242 Completed - Esophageal Cancer Clinical Trials

Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Start date: December 14, 2015
Phase: Phase 3
Study type: Interventional

The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.

NCT ID: NCT02569086 Completed - Sepsis Clinical Trials

Piperacillin PK Analysis in Severe Sepsis Patients

Start date: November 1, 2015
Phase: N/A
Study type: Observational

Antibiotic dosing in septic patients poses a challenge for clinicians due to the pharmacokinetic changes seen in this population. Piperacillin/tazobactam is often used for empirical treatment, and initial appropriate dosing is crucial for reducing mortality. The investigators aim was to determined the pharmacokinetic profile of piperacillin 4g every 8 hour in 22 patients treated empirically for sepsis and severe sepsis. A PK population model was be established with the dual purpose to assess current standard treatment and to simulate alternative dosing regimens and modes of administration. Time above the minimal inhibitory concentration (T>MIC) predicted for each patient was evaluated against clinical breakpoint MIC for Pseudomonas Aeruginosa (16 mg/L). Pharmacokinetic-pharmacodynamic (PK-PD) targets evaluated were 100% f T>MIC and 50% fT>MIC.

NCT ID: NCT02567318 Completed - Pain Clinical Trials

Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia?

Start date: October 2015
Phase: N/A
Study type: Interventional

The purpose of this prospective study is to investigate the degree of association between the volume of important pain-relevant structures in the brain and the size of the areas of secondary hyperalgesia.

NCT ID: NCT02565914 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation

Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744), VX14-661-106 (Study 106, NCT02347657), VX14-661-107 (Study 107, NCT02516410), VX14-661-108 (Study 108, NCT02392234), VX14-661-109 (Study 109, NCT02412111), VX14-661-111 (Study 111, NCT02508207), VX15-661-112 (NCT02730208), and VX16-661-114 (NCT03150719). The study is designed to evaluate the safety and efficacy of long-term treatment of VX-661 in combination with ivacaftor.