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NCT ID: NCT03405935 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate Switching From an E/C/F/TAF Fixed-Dose Combination (FDC) Regimen or a TDF Containing Regimen to B/F/TAF FDC in Human Immunodeficiency Virus-1 (HIV-1) Infected Participants Aged ≥ 65 Years

Start date: March 1, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.

NCT ID: NCT03405844 Completed - Shoulder Injury Clinical Trials

A Static Passive Stretching on Glenohumeral Rotation Range of Movement in Elite Swimmers

Start date: September 15, 2017
Phase: N/A
Study type: Observational

Shoulder injury is a common problem of overhead athletes, as swimmers. It's reported a reduction of side-to-side glenohumeral rotation from 11 to 18 degrees can increase 1.9 points the injury risk, because an alteration in biomechanics can turn lead to clinical findings of impingement and labral pathology. Posterior deltoid is a main muscle for propulsion in swimming stroke. To our knowledge, it isn't known how a posterior deltoid static passive stretch could reduce glenohumeral rotation restriction after swimming competition.

NCT ID: NCT03405714 Completed - Epilepsy Clinical Trials

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy

Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of age with epilepsy.

NCT ID: NCT03404440 Completed - Clinical trials for Helicobacter Pylori Infection

Eradication of Helicobacter Pylori With a Lactobacillus Reuteri Strain Plus Proton Pump Inhibitor

Start date: January 15, 2016
Phase: N/A
Study type: Interventional

Meta-analyses involving >4000 subjects with probiotics added to antimicrobial Helicobacter pylori eradication therapy in populations with antibiotic resistance have reported a mean increase in eradication rate of 12.2%. It is unclear how to translate that result into clinical practice. To evaluate whether administration of Lactobacillus reuteri plus a PPI without antibiotics would eradicate H. pylori infections. This was a double-blind placebo-controlled randomized 2 site study of L. reuteri (2 x 108 CFU L. reuteri DSM 17938 plus 2 x 108 CFU L. reuteri ATCC PTA 6475) 7 times per day or matching placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative 13C-UBT, 4 weeks after therapy. Sample size was based on obtaining >50% cures to be clinically useful as monotherapy.

NCT ID: NCT03404362 Completed - Bone Metastases Clinical Trials

MRgFUS Versus EBRT in Patients With Metastatic Non-spinal Bone Disease

Start date: January 2017
Phase: N/A
Study type: Interventional

The objective of this trial is to collect and compare safety and effectiveness data of Magnetic Resonance guided Focused Ultrasound (MRgFUS) using the ExAblate 2100 device and radiotherapy in the treatment of metastatic bone tumors. This study is designed as a prospective, double arm, non-randomized study with External Beam radiation therapy (EBRT) serving as control arm. The study hypothesis is that MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT.

NCT ID: NCT03403933 Completed - Clinical trials for Cardiovascular Diseases

Vitamin D Supplementation on in Major Orthopedic Surgery

Start date: January 16, 2017
Phase: Phase 4
Study type: Interventional

Prospective, monocentric study in open, aimed at evaluating the effects of supplementation with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing major orthopedic surgery.

NCT ID: NCT03403075 Completed - Clinical trials for Hematologic Neoplasms

Therapeutic Education in Physical Activity (ETAF)

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

To date, studies published on multidimensional rehabilitation programs are addressed to patients with different types of cancer and, frequently, these studies only include a limited number of patients with blood neoplasms. So, there is no evidence of the effectiveness of multidimensional rehabilitation programs in this particular category of patients. A systematic review of the effectiveness of aerobic exercise alone, not associated with therapeutic education, has recently been conducted in adult individuals with hematological malignancies (reference 25386666). The review highlighted the effectiveness of physical activity on the quality of life of the target population. However, the medium and long term effects that physical exercise have on other clinically relevant endpoints, such as fatigue, psychological distress, and physical performance level, remain to be clarified. Thus, it is important to investigate the effectiveness of multidimensional interventions that integrate physical activity to therapeutic education targeted at the specific needs of individuals with blood neoplasm. The aim of this study is to evaluate, in blood cancer patients, the feasibility of a therapeutic education program associated with physical activity, and to verify its effect by a long-term follow-up.

NCT ID: NCT03402841 Completed - Clinical trials for Non-Germline BRCA Mutated Ovarian Cancer

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

OPINION
Start date: January 30, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy

NCT ID: NCT03402815 Completed - Inflammation Clinical Trials

Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

Start date: January 1, 2015
Phase: Phase 4
Study type: Interventional

The investigator tested the efficacy of maraviroc intensification on down-regulating atherosclerotic progression in HIV infected patients with optimal viro-immunologic control and at high cardiovascular risk.

NCT ID: NCT03400904 Completed - Brain Injuries Clinical Trials

Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.

ENIO
Start date: September 6, 2018
Phase:
Study type: Observational

Rationale Prolonged mechanical ventilation (MV) is common in patients with severe Brain Injury (BI). Guidelines for the management of extubation are largely lacking for patients with BI, and the role of tracheostomy is highly uncertain. More important, data on practice of management of extubation is yet underreported, as is the use of tracheotomy in this specific subset of critical care patients. Objective The objective of this prospective observational study is to describe the management of extubation and tracheostomy in intensive care unit (ICU) patients with BI. The aim is to describe the incidence of extubation failure and the rate of tracheostomy. Study design The "Extubation strategies in Neuro-Intensive care unit patients, and associations with Outcomes (ENIO)" is an observational multicentre international cohort study. Study population The investigators will include patients undergoing BI, with an initial Glasgow Coma Score ≤ 12 and with a delivered duration of mechanical ventilation (MV) ≥ 24 hours at ICU admission. The inclusion period will last 6 months in total, and each centre is expected to include at least 24 patients during this period. With over 60 ICUs participating worldwide, we expect to include 1500 patients. Main parameters Parameters to be collected include: general neurological management, ventilatory management, general ICU complications, specific data on extubation and tracheostomy, general in-ICU outcomes and in-hospital mortality. Nature and extent of the burden and risks associated with participation Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts and/or (written or electronic) medical records systems bears no risk to the patients.