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NCT ID: NCT03748849 Completed - Low Back Pain Clinical Trials

Pain Sensory Profile Changes Following Treatment of Chronic Low Back Pain

LBP
Start date: January 20, 2016
Phase:
Study type: Observational

Several cross-sectional studies have demonstrated that patients with chronic low back pain have higher levels of pain sensitivity (local and widespread) when compared to controls. It is unclear however, if improvements in pain and function are reflected in a decrease in the sensitivity of pain mechanisms. This study compares the pain sensory profile in patients with chronic low back pain before and after a period of physiotherapy treatment. To account for natural fluctuations in pain sensitivity, healthy age matched controls are also measured twice

NCT ID: NCT03746717 Completed - Clinical trials for Metastatic Bone Disease of the Proximal Femur

Occlusive Skin Closure May Reduce Wound Drainage After Tumor Hip Arthroplasty

Start date: January 15, 2017
Phase: N/A
Study type: Interventional

Study Type: Investigator initiated, non-significant risk Study Objective(s): To establish the effect of occlusive wound closure with the DERMABONDTM PRINEO skin closure system, compared to routine wound closure with skin staples, on post-operative wound discharge (PWD) after tumor arthroplasty of the hip Study Population: Patients with secondary tumors of bone, undergoing tumor resection and primary endoprosthetic reconstruction involving the hip joint Inclusion Criteria: - Bone resection and endoprosthetic reconstruction for metastatic bone lesions involving the proximal femur or acetabulum - Imminent, or de-facto pathologic fractures of proximal femur and/or acetabulum, requiring endoprosthetic reconstruction (with or without bone resection) involving the hip joint Exclusion Criteria: - Minors - Pregnant and breast-feeding women - Skin defects and wound conditions not amenable to primary wound closure and other DERMABOND PRINEO contraindications - Underlying infection - Total femur replacements - Implant revision procedures Structure: Open 2-arm prospective randomized controlled trial. Duration of Study: 18 -24 months Multi-center: No Masking/Blinding: No Method of Subject Assignment: Block Randomization (10 in each block) Concurrent Control: Active - wound closure with skin staples Estimated Total Sample Size: 70 subjects will be enrolled in this study Statistical Rationale Provided: Yes Statistical Methods: Student t test for unpaired data Study Endpoints: - Time to dry wound status (in post-operative days) - Duration of antibiotic use (in post-operative days) - Length of hospital stay (in post-operative days)

NCT ID: NCT03746275 Completed - Atherosclerosis Clinical Trials

Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid

XATOA
Start date: November 13, 2018
Phase:
Study type: Observational

In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.

NCT ID: NCT03743116 Completed - Clinical trials for Postoperative Complications

Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA

Start date: November 13, 2018
Phase:
Study type: Observational

Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty

NCT ID: NCT03741556 Completed - Ankle Fractures Clinical Trials

Prognostic Factors Following Ankle Fractures

Start date: November 7, 2018
Phase:
Study type: Observational [Patient Registry]

Ankel fractures is a common fracture. Most patients experience that the regain normal range of motions and limited pain within the first 6 months following ankel fracture, but not all. The aim of the study is to determine if any prognostic factors is associated with a worse outcome.

NCT ID: NCT03740919 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes

PRONTO-Peds
Start date: April 7, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).

NCT ID: NCT03739294 Completed - Pharmacokinetics Clinical Trials

Urine Concentrations of Vilanterol After Inhaled Administration of Vilanterol/Fluticasone Furoate

Start date: February 8, 2019
Phase: Phase 2
Study type: Interventional

Introduction: The prevalence of asthma and exercise-induced bronchoconstriction is high in the athletic population. In endurance sport, the prevalence has been reported to be as high as 30-50% compared to the general population prevalence of approximately 5-10% in Western countries. First-line treatment in asthma is reliever medication and inhaled corticosteroids (ICS). Therefore, β2-adrenoceptor agonists and ICS are commonly prescribed drugs to athletes. Although long-acting β2-agonists (LABA) are the most commonly used β2-agonists in asthma management, development of ultra-long acting β2-agonists (U-LABA) as vilanterol may change this. U-LABA has a long duration of action (24 hours) compared with LABA (12 hours). The accumulated number of inhalations per day for elite athletes may thus be reduced when prescribed with U-LABA as compared to LABA. Use of β2-agonists are restricted by the World Anti-Doping Agency (WADA). As of 2018, β2-agonists salbutamol, formoterol and salmeterol are allowed by inhalation in therapeutic doses, whereas other β2-agonists, such as terbutaline and vilanterol still require the athlete to obtain a therapeutic use exemption (TUE). To discriminate therapeutic use from supra-therapeutic misuse, WADA has established urinary thresholds and decision limits based on urine concentrations of salbutamol, salmeterol and formoterol. However, while data on urine concentrations of these three β2-agonists are well-described in studies that simulate sport-specific situations that are applicable for doping control, no such data exist for the novel U-LABA vilanterol. For instance, asthmatic athletes using β2-agonists usually inhale the drug before training or competition as prophylaxis for bronchoconstriction. Thus, studies are needed to investigate the urine concentrations of vilanterol after inhaled administration in set-ups that are applicable to doping control which this study aims to investigate. Method: The study is divided in two phases. The first phase consists of a pharmacokinetic pilot trial (EXP1). Depending on the analytical outcome of the pilot study, the study proceeds into the second phase, which is a larger pharmacokinetic trial (EXP2). Both EXP1 and EXP 2 are open label studies. EXP1: 6 healthy, well trained individuals are recruited to perform two trial days. First trial day consists of inhalation of the study drug in 4 times therapeutic dose followed by an exercise session. Before second trial day subjects inhales 4 times the therapeutic dose at home and on day 7 perform a training session. Urine and blood are collected in the following 72 hours both days. EXP2: 20 healthy, well trained individuals are recruited to perform four trial days in the same way as EXP1. But here both normal use and four times normal dose is investigated.

NCT ID: NCT03739268 Completed - Clinical trials for Type 2 Diabetes Mellitus

GLP-1-mediated Gluco-metabolic Effects of Bile Acid Sequestration

SeveX
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the potential GLP-1-mediated contribution to the well-established glucose-lowering effect of sevelamer-induced bile acid sequestration . Exendin9-39 has been demonstrated to act as a potent and specific GLP-1 receptor antagonist with no partial agonistic potential and is considered a useful tool in the assessment of GLP-1 physiology. The aim is to evaluate any contribution of sevelamer-induced GLP-1 secretion to the reduced plasma glucose concentrations observed after treatment with sevelamer. A randomised placebo-controlled cross-over study involving two 17-day treatment periods with sevelamer and placebo, respectively, in metformin-treated patients with type 2 diabetes, will be conducted. The impact of bile acid sequestration on GLP-1 secretion and effect will be examined during two randomised experimental days after 15 and 17 days of treatment with sevelamer (1,600 mg three times a day) and placebo, respectively. During each of these two experimental days, a meal test with concomitant exendin9-39 infusion or placebo will be performed (for evaluation of any GLP-1-mediated effects). Postprandial plasma glucose excursion is the primary endpoint, and secondary endpoints include postprandial plasma/serum excursions of insulin, C-peptide, GLP-1, glucagon, glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-2 (GLP-2), peptide YY (PYY), oxyntomodulin, ghrelin, fibroblast growth factor (FGF)-19, FGF-21, C4 (an intermediate in the de novo synthesis of bile acids), cholecystokinin (CCK), bile acids and plasma lipids. Furthermore, gastric emptying, gallbladder emptying, liver fat content, appetite and ad libitum food intake will be examined.

NCT ID: NCT03738644 Completed - Ischemic Stroke Clinical Trials

Monitoring Stroke Patients With Near-infrared Spectroscopy Before, During and After Endovascular Treatment

Start date: November 20, 2018
Phase:
Study type: Observational

The purpose of this study is to examine the hemodynamics of stroke patients with near-infrared spectroscopy before, during and after endovascular treatment and their relations to disabilities and mortality 3 months after treatment.

NCT ID: NCT03734718 Completed - Clinical trials for Diabetes Mellitus, Type 1

The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes