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NCT ID: NCT04081376 Completed - Healthy Volunteers Clinical Trials

Generation of Biological Samples Positive to Hydromorphone for Anti-doping Control

HM
Start date: November 20, 2019
Phase: Phase 1
Study type: Interventional

Background: Hydromorphone (HM) is a semi-synthetic derivative of morphine used for pain control. Like other opiates, due to its high potential of abuse HM is included on the World Anti-Doping Agency (WADA) list of prohibited substances. Hypothesis: The oral administration of hydromorphone hydrochloride in healthy subjects allows generating detectable concentrations of the drug in urine. Positive urine samples will enable to identify analytical strategies for doping control. Objectives: Primary objective: To measure the concentrations of hydromorphone in urine for anti-doping control samples. Secondary objective: To identify metabolites and precursors of hydromorphone in urine. To assess safety and tolerability of the drug used. Methods: Phase I, open, non-randomized clinical trial, with a treatment condition (hydromorphone) administered orally to 2 subjects.

NCT ID: NCT04079452 Completed - HIV-1-infection Clinical Trials

Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals

Start date: February 18, 2020
Phase: Phase 3
Study type: Interventional

Doravirine is a new HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) that has demonstrated a good efficacy and safety profile in clinical trials. It functions by inhibiting viral replication of both wild-type virus and most common NNRTI variants. It is dosed orally once daily and always given in combination with other HIV-1 active agents as part of highly active antiretroviral therapy. Initial pharmacokinetic studies demonstrated not extensive binding to plasma proteins, which may be crucial determinant for penetration to different reservoirs such as the central nervous system (CNS). This study will address two important issues: The pharmacokinetic profile of Doravirine in cerebrospinal fluid (CSF) as well as the maintenance of HIV suppression in CSF. The assessment of concentrations as well as the antiviral activity of new antiretroviral drugs in compartments such as CNS is relevant to avoid HIV-related neurocognitive disorders as well as for future cure strategies. In addition, the role of unbound ARV drug concentrations has been scarcely evaluated.

NCT ID: NCT04078256 Completed - Injury;Sports Clinical Trials

The Importance of Exercise to Prevent Injuries in Athletes

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Introduction: running is one of the most accessible and practiced sports in the world since the 21st century. Unfortunately, the incidence of injuries in the population that practices it is high regardless of experience, although the risk of injury increases in amateur runners. One of the main keys to reduce the incidence of running related injuries may be to improve the ability to reduce the load or impact. For this, there are different strategies such as a gradual increase in the load to run, and exercise within which is muscle strengthening and balance training or proprioception. Objective: to verify the effectiveness of a program of proprioceptive exercises based on the static and dynamic balance for the reduction of lower limb injuries in amateur runners during the competition season.

NCT ID: NCT04077411 Completed - Clinical trials for Severe Traumatic Brain Injury

Approaches and Decisions for Acute Pediatric TBI Trial

ADAPT
Start date: February 20, 2014
Phase:
Study type: Observational

Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT) is an international research study designed to evaluate the impact of interventions on the outcomes of children with severe traumatic brain injury. Pediatric traumatic brain injury (TBI) is the leading killer of children, resulting in more than 7000 deaths and $2 billion in acute care costs each year. Despite this large burden of disease, advances in the field have been limited due to weak evidenced-based guidelines and the limitations of randomized, controlled trials (RCTs) to demonstrate efficacy of single treatment strategies due to wide treatment variability. ADAPT is a practical study design in a novel approach - an observational cohort study designed to evaluate the association of 6 aspects of pediatric TBI care with outcomes using statistical modeling to correct for confounding variables. Completion of this study will provide compelling evidence to change clinical practices, provide evidence for new Level II recommendations for future guidelines and lead to improved research protocols that would limit variability in TBI treatments - helping children immediately through better clinical practices and ultimately through more effective investigation.

NCT ID: NCT04076670 Completed - Palliative Care Clinical Trials

A Psychological Intervention for Family Caregivers of Palliative Care Patients

Start date: May 31, 2016
Phase: N/A
Study type: Interventional

This work aims to study the benefits a psychological intervention in family caregivers of palliative care patients can have for reducing anxiety, depression and overburden. A parallel randomized controlled trial of two groups was performed. Information was collected on 154 family caregivers of patients at the end of life during the moments before and after the intervention.

NCT ID: NCT04076462 Completed - Acromegaly Clinical Trials

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

ACROINNOVA 1
Start date: August 19, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.

NCT ID: NCT04076423 Completed - HIV Infections Clinical Trials

A Phase IV Study to Assess the Impact of the Change of Antiretroviral Treatment From Dual Therapy to Triple Therapy on Inflammation in Patients With HIV Infection

InSTINCT
Start date: October 10, 2019
Phase: Phase 4
Study type: Interventional

242 patients (121 patients in each of the two treatment arms) will be included with a confirmed diagnosis of HIV-1 infection and with a stable antiretroviral treatment during more than 48 weeks with dual therapy (DTG + 3TC)

NCT ID: NCT04075825 Completed - Crohn's Disease Clinical Trials

Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Start date: November 4, 2019
Phase: Phase 3
Study type: Interventional

The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

NCT ID: NCT04075604 Completed - Breast Cancer Clinical Trials

A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

CheckMate 7A8
Start date: October 18, 2019
Phase: Phase 2
Study type: Interventional

A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer

NCT ID: NCT04075422 Completed - Clinical trials for Clostridium Difficile Infection

Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.

BEFORE
Start date: October 1, 2019
Phase:
Study type: Observational

The main hypothesis of the study is that Bezlotoxumab is well tolerated and effective in reducing the recurrence of ICD (Clostridium Difficile infection) in patients with a high risk of recurrence in the first episode of ICD. As a consequence, the number of readmissions and hospital stays, will be reduced in patients treated with Bezlotoxumab.