Clinical Trials Logo

Filter by:
NCT ID: NCT03806166 Active, not recruiting - Diabetic Foot Clinical Trials

Short or Long Antibiotic Regimes in Orthopaedics

SOLARIO
Start date: February 21, 2019
Phase: N/A
Study type: Interventional

Research question: If adults with bone or joint infection have local antibiotic therapy, can they do without prolonged treatment with antibiotics by mouth (oral) or injection? Adults with bone or joint infections are usually given long courses of oral antibiotics or into a vein (intravenous) following surgery. It is also safe to give antibiotics directly into the bone or joint at the time of surgery: this is called local antibiotic therapy. This study investigates whether using local antibiotic therapy would allow shorter courses of oral or intravenous antibiotics, in order to limit antibiotic resistance, side effects and cost. This study compares short against long courses of oral or intravenous antibiotics for adults who have been given appropriate local antibiotic therapy to treat bone or joint infection. Patients who can take part will be randomly divided into two groups within 7 days of surgery. One group will stop oral or intravenous antibiotics, while the other group will continue for 4 weeks or more (standard treatment). Adults with bone and joint infections who have already had surgery and local antibiotic therapy will be invited. Patients will not take part if they need intravenous antibiotics for another reason, or if their infection is caused by bacteria resistant to the antibiotic(s) used in their local antibiotic therapy. Main measurement: how many patients' infections return within 12 months after surgery. This will be decided by a group of doctors who do not know what treatment the patient received. Other important measurements: serious adverse events; side-effects; quality of life; cost of treatment. Patients will be asked questions at their usual clinic visits, and will be given a questionnaire at the start of treatment and 1 year later.

NCT ID: NCT03788005 Active, not recruiting - Clinical trials for Chronic Subdural Hematoma

GET-UP Trial: Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas

GET-UP
Start date: April 7, 2019
Phase: N/A
Study type: Interventional

Compare rates of medical complications, recurrence and outcome in 2 randomized groups of patients with surgical chronic subdural hematomas. The intervention group will be assigned to early mobilization (within 12 hours of the surgical procedure). The control group will be assigned to bed rest for 48 hours.

NCT ID: NCT03782207 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

IMreal
Start date: February 7, 2019
Phase:
Study type: Observational

This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.

NCT ID: NCT03778931 Active, not recruiting - Breast Cancer Clinical Trials

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

EMERALD
Start date: May 10, 2019
Phase: Phase 3
Study type: Interventional

This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

NCT ID: NCT03766919 Active, not recruiting - Heart Failure Clinical Trials

Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector

FRIENDS
Start date: December 27, 2018
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE fixation type models (single and dual coil: INVICTA 1CT, INVICTA 2CT).

NCT ID: NCT03765918 Active, not recruiting - Clinical trials for Head and Neck Neoplasms

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Start date: December 17, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

NCT ID: NCT03762850 Active, not recruiting - Clinical trials for Immunoglobulin A Nephropathy

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

PROTECT
Start date: December 11, 2018
Phase: Phase 3
Study type: Interventional

To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).

NCT ID: NCT03759379 Active, not recruiting - Clinical trials for Transthyretin Amyloidosis

HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)

Start date: February 14, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the 18 month Treatment Period. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all participants will be randomized to receive vutrisiran SC injection once every 6 months (q6M) or q3M in the Randomized Treatment Extension (RTE) Period.

NCT ID: NCT03751670 Active, not recruiting - Clinical trials for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Pulmonary Rehabilitation During Acute Exacerbations of Chronic Obstructive Pulmonary Disease: a Mixed-methods Approach

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

This study aims to i) assess the short-, mid- and long-term effectiveness of a patient-centred community-based pulmonary rehabilitation (PR) programme during during acute exacerbations of chronic obstructive pulmonary disease (AECOPD); ii) establish the minimal clinical important differences for PR in AECOPD for clinical and patient-reported outcome measures; and iii) evaluate patients' perspectives and self-reported impact of the PR programme. Patients with AECOPD will be recruited via clinicians at hospitals and primary care centres. Sociodemographic, anthropometric and clinical data; vital signs and peripheral oxygen saturation; symptoms (dyspnoea, fatigue, cough and sputum); lung function; physical activity level; peripheral muscle strength; functional status; exercise tolerance; impact of the disease and health-related quality of life will be collected within 24h-48h of the AECOPD diagnosis. Then, patients will be randomly allocated to either conventional treatment or conventional treatment plus PR. After 3 weeks, all outcome measures will be reassessed. Additionally, follow-ups at 2, 6 and 12 months will be performed through phone calls to assess the number of recurrent AECOPD, healthcare utilization and mortality. Conventional treatment will consist on daily medical treatment prescribed by the physician (i.e., medication). Community-based PR will involve 6 sessions (2 times per week) of breathing retraining and airway clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training, education and psychosocial support. It is expected that, by including PR in the treatment of patients with AECOPD, they will express greater improvements in a shorter period of time and experience a decrease number of re-exacerbations and healthcare utilization.

NCT ID: NCT03748641 Active, not recruiting - Clinical trials for Castration-Resistant Prostatic Cancer

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

MAGNITUDE
Start date: January 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.