Clinical Trials Logo

Filter by:
NCT ID: NCT03165240 Completed - Clinical trials for Diabetic Nephropathies

This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated

Start date: October 5, 2017
Phase: Phase 1
Study type: Interventional

The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [ARB]. Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio [UACR].

NCT ID: NCT03164993 Completed - Clinical trials for Triple Negative Breast Cancer

Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer

ALICE
Start date: June 1, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled phase II study evaluating the safety and efficacy of Atezolizumab when combined with immunogenic chemotherapy in subjects with metastatic triple-negative breast cancer. Atezolizumab, pegylated liposomal doxorubicin and cyclophosphamide are the Investigational Medicinal Products (IMPs).

NCT ID: NCT03163433 Completed - Quality of Life Clinical Trials

Feedback in the Consultation - a Dialogue-based Tool in Personalised Care Planning Using Systematic Patient Involvement

Start date: June 12, 2017
Phase: N/A
Study type: Interventional

The aim of the study is to examine the potentials of involving patients with metastatic melanoma in their own care planning through systematic use of patient-reported outcome measures (PROM). Furthermore, to examine the outcome of health-related quality of life, self-efficacy and impact on the patient-physician interaction. Patients (N=282) will be included from three highly specialized hospitals in Denmark. At one hospital patients will complete PROM before each consultation during a year (intervention group). At the two other hospitals patients will not complete PROM (control group). In addition to baseline, measurements will take place after three, six and 12 months. The project is organized and executed with patient involvement in the research process.

NCT ID: NCT03161938 Completed - Clinical trials for Postoperative Complications

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase

DEX-GANZ
Start date: April 24, 2017
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after periacetabular osteotomy. Primary outcome is the proportion of patients who have moderate to severe postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific complications in the post anaesthesia phase, pain and nausea the first 5 days, wound infection and readmissions the first 30 days after surgery. The investigators hypothesize that the frequency of moderate to severe pain and organspecific complications in the post anaesthesia care unit will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections or readmissions.

NCT ID: NCT03161093 Completed - Clinical trials for Osteoarthritis, Knee

A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

FACT OA1
Start date: August 17, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip 3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip 5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip 6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip

NCT ID: NCT03160885 Completed - Atopic Dermatitis Clinical Trials

Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 2 (ECZema TRAlokinumab Trial no. 2)

ECZTRA 2
Start date: June 12, 2017
Phase: Phase 3
Study type: Interventional

Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.

NCT ID: NCT03160495 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens

FIGHHT
Start date: March 29, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to investigate if heterogeneity in head and neck squamous cell carcinoma as seen in functional imaging with PET/MR can be correlated to biologic heterogeneity in surgical specimens.

NCT ID: NCT03159910 Completed - Shoulder Pain Clinical Trials

Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

Start date: August 14, 2017
Phase: N/A
Study type: Interventional

Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder complaints. Hypothesis: The Shoulder-Café, which unifies education, diagnostic clarification, supervised and home-based shoulder exercises, and advice from a health and safety consultant on workplace interventions, will reduce shoulder exposures and shoulder complaints more effectively than an individual-oriented control intervention with home-based shoulder exercises and written general advice on workplace interventions.

NCT ID: NCT03159741 Completed - Healthy Clinical Trials

Investigation of GLP-2 Mechanism of Action (GA-8)

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

Glucagon-like peptide-2 (GLP-2) is a naturally occuring hormone secreted to the circulation in response to food ingestion. Previous studies have shown that GLP-2 and incretins inhibit the bone resorption. However, the mechanism is unknown. In the present study we will investigate the mechanism of action using a receptor specific inhibitor.

NCT ID: NCT03158753 Completed - Pain, Postoperative Clinical Trials

Perfusion Index and Pain in Ankle Surgery

PIPA
Start date: February 2, 2017
Phase: N/A
Study type: Observational

Perfusion index (PI) measured via a pulse oximeter has been shown to correlate with activation of the sympathetic nervous system, such as by pain stimulation, as a result of involuntary contraction of the arterioles. Thus PI holds potential for use as a tool for "objective pain measurement", although its practical usefulness and dependability as such have not previously been investigated. The investigators aim to explore associations between changes in PI and onset of pain following cessation of regional anaesthesia in alert patients following ankle fracture surgery. Methods: The investigators report an exploratory, observational analysis of prospectively gathered PI data from patients undergoing regional anaesthesia with spinal or peripheral nerve block for ankle fracture surgery as participants of the randomised AnAnkle Trial (EudraCT: 2015-001108-76). PI is measured on an unaffected extremity in approximately 20 consecutive patients already included in the AnAnkle Trial at Herlev University Hospital, evenly distributed between spinal anaesthesia (SA) and peripheral nerve block (PNB). Both anaesthesia forms and pain medication regimes are standardised as part of AnAnkle Trial and participants register pain scores on a 0-10 numeric rating scale every three hours and register the time of cessation of anaesthesia identified by return of sensation to the ankle. Morphine consumption is also registered. The investigators will explore correlations of changes in PI to increases in pain upon cessation of the regional anaesthesia and, secondly, differences in cessation related PI changes with SA versus PNB. Ethics: All participants have already given informed, written consent for use of this data for the AnAnkle Trial. All necessary ethical and legislative approvals have been obtained for initiation of AnAnkle Trial in July 2015.