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NCT ID: NCT02323529 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1

HT-1
Start date: December 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to look at the steady-state serum concentrations of nitisinone when switching from twice daily and once daily dosing.

NCT ID: NCT02323503 Completed - Device Replacement Clinical Trials

Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication

BioCONTINUE
Start date: June 9, 2015
Phase:
Study type: Observational [Patient Registry]

Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question. 80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device. So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.

NCT ID: NCT02323191 Completed - Solid Cancers Clinical Trials

A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors

Start date: January 19, 2015
Phase: Phase 1
Study type: Interventional

This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment. Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.

NCT ID: NCT02322489 Completed - Clinical trials for Delayed Onset Muscle Soreness

Efficacy of Microcurrent Therapy After Eccentric Exercise

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

15 participants will be included in the present study. They will attend two groups of three sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months: - session 1 and 4 (performed a few days before the experimental session): session for participants to get familiarized with the test battery. - session 2 and 5: experimental session (the test battery followed by the provocative task, the test battery, the one-hour "treatment" and the test battery again). - session 3 and 6 (performed 2 days later): the test battery. The test battery included flexibility, functional, pressure pain threshold tests. The provocative task was an isokinetic eccentric task for knee flexors and extensors. The treatment was either a microcurrent therapy or a placebo microcurrent therapy.

NCT ID: NCT02320877 Completed - OSA Clinical Trials

Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea

Start date: December 2014
Phase: N/A
Study type: Interventional

In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep apnea (OSA) (AHI > 15/h sleep) will be included and treated with mandibular advancement devices (MAD). These patients will undergo cardiovascular examination; echocardiography and 24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients. These cardiovascular examinations will take place before and during MAD therapy.

NCT ID: NCT02320084 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care

OPAL
Start date: September 2013
Phase:
Study type: Observational

The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

NCT ID: NCT02319915 Completed - Knee Prosthesis Clinical Trials

Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.

Start date: February 18, 2015
Phase: Early Phase 1
Study type: Interventional

Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or without adrenaline, in a population of patients undergoing knee replacement.

NCT ID: NCT02319148 Completed - Healthy Volunteers Clinical Trials

A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

Start date: July 2014
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.

NCT ID: NCT02319044 Completed - Clinical trials for Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck

Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck

Start date: April 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.

NCT ID: NCT02319005 Completed - Clinical trials for Amyloidosis, Hereditary

ENDEAVOUR: Phase 3 Multicenter Study of Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)

Start date: December 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has been discontinued; patients are being followed-up for safety.