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NCT ID: NCT02853123 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

Start date: September 22, 2016
Phase: Phase 4
Study type: Interventional

The primary objective of the present study is to evaluate the effect of tiotropium + olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity of breathlessness during the 3min constant speed shuttle test (CSST). A secondary objective is to explore the relationship between reductions in breathlessness during the 3min CSST and reductions in breathlessness during activities of everyday living as measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following bronchodilator therapy.

NCT ID: NCT02852421 Completed - Anesthesia Clinical Trials

Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks

Start date: August 2013
Phase: N/A
Study type: Interventional

Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast surgeries resulting in reduced narcotic consumption, reduced nausea, improved quality of recovery, reduced chronic pain and possibly reduced metastasis with breast cancer. Traditionally, PVB is done by multiple injections below T1-T5 transverse processes. With multiple injections, the risk is increased for a pleural, an intraneural, and/or an intravascular injection. Recently, ultrasonography is being used to facilitate PVB. The use of ultrasound imaging enables real-time needle visualization during the procedure. This may improve efficacy and reduce the chances of complication like pneumothorax. Currently, there are no data comparing ultrasound-guided single injection technique with multiple injections technique with regards to extent of spread for PVB. Our objective is to investigate the extent of dermatomal spread of PVB when equal volumes of local anesthetic are injected at one versus five paravertebral sites for patients undergoing major breast surgery. In addition, the investigators wish to compare the performance time and duration of analgesia. Methodology: After local REB approval, 72 patients undergoing a unilateral mastectomy with or without axillary node dissection will be randomized to receive either single or multiple injections PVB. The PVB will be performed in prone position under real-time ultrasound guidance using a para-sagittal approach.The patients in single injection group will receive single injection PVB at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous sham injections. Patients in the multiple injection group will receive five injections of PVB from T1 to T5 level. 5 ml of 0.5% ropivacaine will be injected at each level. Pleural drift will be used as a sign of correct needle tip location and local anaesthetic spread. The pinprick method will be used to assess the extent of dermatomal blockade, 20 minutes following the completion of procedure. All patients will receive a standardized general anesthesia for the surgery. Any adverse events including pneumothorax, epidural spread, LA toxicity/seizure, total spinal, will be recorded.

NCT ID: NCT02851797 Completed - Clinical trials for Duchenne Muscular Dystrophy

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

Start date: June 6, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective The primary objective of the study was to establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects. Secondary Objectives The secondary objectives of this study were: - To assess the safety and tolerability of givinostat versus placebo administered chronically in DMD subjects - To evaluate the PK profile of givinostat administered chronically in DMD subjects - To evaluate the impact on quality of life (QoL) and activities of daily living of givinostat versus placebo administered chronically.

NCT ID: NCT02851407 Completed - Clinical trials for Veno-occlusive Disease

Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients

Start date: September 1, 2016
Phase: Phase 3
Study type: Interventional

This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.

NCT ID: NCT02850523 Completed - Perinatal Anxiety Clinical Trials

Cognitive Behavioural Group Therapy for Perinatal Anxiety

CBT-PA
Start date: September 2016
Phase: N/A
Study type: Interventional

This study evaluated the effectiveness of a 6-week, group-based, cognitive behavioural therapy (CGBT) program for women with anxiety disorders (with or without comorbid depressive symptoms) during pregnancy or early postpartum. The CBGT program was evaluated compared to a 6-week waitlist condition.

NCT ID: NCT02850289 Completed - Clinical trials for Hepatitis C, Chronic

APPROACH Study: Quality of Life and Outcomes Assessment in Participants With Chronic Hepatitis C (CHC) Treated With Pegylated Interferon (PEG-IFN) Alfa-2a and Ribavirin

Start date: April 2006
Phase: N/A
Study type: Observational

This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC). Study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. An additional follow-up visit at week 72 will be required for participants with an HCV genotype other than 2 or 3. Quality of life data will be collected at baseline, and at each follow-up visit.

NCT ID: NCT02849977 Completed - Clinical trials for Pro-opiomelanocortin (POMC), Proprotein Convertase Subtilisin/Kexin Type 1 (PCSK1) and Leptin Receptor (LepR) Gene Mutations

Genetic Testing and Phenotypic Characterization of Severely Obese Pediatric and Adult Volunteers

Start date: September 28, 2016
Phase:
Study type: Observational

The purpose of this screening study is to identify people who have a rare genetic cause of obesity - specifically three genetic variants (a change in the DNA structure) of the POMC, PCSK1 and LepR genes that are currently known to result in obesity. This screening study will not include any investigational drugs. You will be asked to provide a DNA sample and answer some questions about your medical history and hunger.

NCT ID: NCT02849626 Completed - Clinical trials for Partial-Onset or Primary Generalized Tonic-Clonic Seizures

Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

Start date: November 16, 2016
Phase: Phase 3
Study type: Interventional

This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.

NCT ID: NCT02849405 Completed - Arteriosclerosis Clinical Trials

Evaluation of the Capacity of a Camera to Identify Signs of Arteriosclerosis in Retinal Arterioles

Start date: December 21, 2016
Phase: N/A
Study type: Interventional

Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls. It is known to be the principal cause of coronary artery disease (CAD). Arteriosclerosis has an impact on the entire vascularization including the microvascularization. The retina is a nervous tissue that is supported by microvascularization. Therefore, systemic diseases that affect the nervous or the cardiovascular system are susceptible to have manifestations in the retina. Retinal signs associated to the risks to develop CAD (qualitative appreciation; diameter and appearance of arterioles) have been suggested. A quantitative approach would strengthen the interpretation of these evaluations. The Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - has the capacity to identify and quantify a variety of biomolecules specific to the retina and the optic nerve. The purpose of this pilot study is to determine if the MHRC has the capacity to detect a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis.

NCT ID: NCT02848742 Completed - Clinical trials for Pigmented Skin Lesion

Dermal Cryotherapy for Treatment of Pigmented Lesions

Start date: June 2016
Phase: N/A
Study type: Interventional

Study to evaluate the ability of the Dermal Cooling System to reduce pigmentation in benign pigmented lesions.