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NCT ID: NCT01909999 Completed - Jaw, Edentulous Clinical Trials

Release of Osteogenic Markers in Immediately and Non-loaded Dental Implants

Start date: March 2010
Phase: N/A
Study type: Interventional

The aim of this study was to compare the release of the osteoprotegerin (OPG), transforming growth factors (TGF-α), osteocalcin (OCN), osteopontin (OPN), and parathyroid hormone (PTH) during osseointegration of dental implants with and without immediate loading. Forty patients were selected and randomly divided into: Group IM - implant and prosthesis placement within 72 hours; and Group NL - implant insertion and no prosthesis placement during 120 days. Peri-implant crevicular fluid (PICF) was collected immediately after implant insertion and with 7, 15, 30, 60, 90, and 120 days after surgery and were evaluated levels of OPG, TGF-α, OCN, OPN and PTH using Luminex assay. Clinical aspects (Sulcus bleeding and peri-implant probing depth) were also assessed. The data were compared using the ANOVA/Tukey and Friedman/Mann-Whitney tests (α=5%).

NCT ID: NCT01907737 Completed - Stroke Clinical Trials

Combined Brain and Peripheral Nerve Stimulation for Stroke

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

Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. We will non-invasively stimulate the brain and peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve stimulation, will enhance effects of motor training to a greater extent than brain stimulation alone, peripheral stimulation alone, or no stimulation.

NCT ID: NCT01907347 Completed - Clinical trials for Intensive Care Unit Patients

Prognosis Value of Bioimpedance Analysis (BIA) Phase Angle at Admission in Intensive Care Unit (ICU) Patients

PAP
Start date: March 1, 2013
Phase: N/A
Study type: Observational

Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is associated with increased morbidity and prolonged recovery. In several clinical conditions, FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. However, solid data to support this association in ICU patients are lacking. Only one retrospective study of 51 ICU patients with acute respiratory failure correlated loss of active cell mass with mortality. In a pilot study performed in 55 ICU patients, the investigators observed that five kHz BIA PhA was significantly related to SOFA (r=0.38, P=0.03). The relation between PhA and mortality remains to be determined in ICU patients. Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of ICU patients. Most of these scores are time consuming and suffer some degree of discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery patients). PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular water (ECW) distribution is suggested by low PhA. PhA measurement does not require anamnestic parameters, body weight, and lab tests. It could easily, accurately and repeatedly measured at bedside. PhA has been correlated with the disease prognosis in HIV infection, hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis patients. These studies suggest that PhA may be useful in determining increased risk of morbidity in the ICU. Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could accurately measure FFM13 and predict survival in cancer patients. Body composition evaluation by CT presents great practical significance due to its routine ICU use in the initial diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has never been evaluated in ICU patients. Therefore, the investigators aim to conduct an international multicentre prospective observational study in ICU patients to assess the prognosis value of BIA PhA at admission, and to compare the performances of BIA and L3-targeted CT for FFM measurement.

NCT ID: NCT01906242 Completed - Clinical trials for Denture Hygiene Protocol

Hygiene Protocol of Complete Dentures

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

Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.

NCT ID: NCT01905943 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia

Start date: November 4, 2013
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.

NCT ID: NCT01904292 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis

Start date: August 15, 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.

NCT ID: NCT01904279 Completed - Clinical trials for Juvenile Idiopathic Arthritis

A Study of Subcutaneously Administered RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis

Start date: July 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis. Patients will receive RoActemra/Actemra subcutaneously every 2 or 3 weeks for 52 weeks.

NCT ID: NCT01903980 Completed - Clinical trials for Epipericardial Fat Necrosis

Epipericardial Fat Necrosis: A Misdiagnosed Condition

epipericardial
Start date: June 2013
Phase: N/A
Study type: Observational [Patient Registry]

Epipericardial fat necrosis is a benign and self-limited condition that mainly curses with acute pleuritic chest pain and therefore must be an important differential diagnosis for patients in emergency department (ED). The knowledge of characteristics symptoms and correct management may avoid misdiagnosis or mistakes with other severe conditions like pulmonary embolism, pericarditis or acute coronary disease. Despite the importance of this entity, only fewer than 40 cases have been reported since 1957, when the condition was first described. We have seen a couple of similar cases in our institution during a short period of time, and we suspect that these numbers doesn`t mean the real prevalence of epipericardial fat necrosis, so maybe this condition could be underdiagnosed. Instead, there isn't a study that tried to estimate an incidence of this entity.

NCT ID: NCT01903733 Completed - Clinical trials for Chronic Myeloid Leukemia

Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

Start date: August 28, 2013
Phase: N/A
Study type: Interventional

The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.

NCT ID: NCT01903031 Completed - HIV-1 Infection Clinical Trials

Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART

Start date: December 30, 2014
Phase: Phase 2
Study type: Interventional

This study was done to look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. The investigators did not know whether the NuvaRing and ARVs interact when they are used together, so this study looked to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study also included HIV-infected women who were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs. Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, the investigators wanted to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of the female genital tract, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.