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NCT ID: NCT04223752 Recruiting - Clinical trials for Nosocomial Pneumonia

Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)

Start date: April 17, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia (NP).

NCT ID: NCT04217642 Recruiting - Hip Fractures Clinical Trials

Hip Fracture in Cauca. Cohort Study

HIPCCO
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

This research project is an observational, analytical, prospective cohort study, which aims to identify and describe the causes of delay in surgical intervention in patients with a diagnosis of hip fracture at Hospital Universitario San José, correlate those factors with complications , the impact of the quality of life and the main outcomes in relation to morbidity and mortality associated with the delay in surgery in the study population. In order to carry out this investigation, the recruitment of patients over 18 years old, who enter our institution with a diagnosis of hip fracture, prior acceptance by the patient or his family member to participate through an informed consent signature is carried out. Subsequently, the research team consults the medical history to monitor the factors that influence the time from admission to surgery. A survey is also conducted to assess the quality of life and how your health status can affect it; which is performed during the hospital stay before surgery, the third day after surgery, one month and 6 months later, the last two surveys are conducted in the control consultation with the treatment team or by call telephone. It is clear that this study does not represent any risk for the participants, the information collected will be confidential and will not be used for any other purpose outside the investigation.

NCT ID: NCT04207723 Recruiting - Clinical trials for Premature Ejaculation

Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment. Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups: - Group 1: Tens + placebo drug therapy - Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy - Group 3: Tens therapy + standard treatment (paroxetine mg) The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).

NCT ID: NCT04185935 Recruiting - Malignant Neoplasm Clinical Trials

Molecular Genetics Studies of Cancer Patients and Their Relatives

Start date: April 18, 1997
Phase:
Study type: Observational

This trial studies the genetic and behavioral factors that may contribute to the development of specific cancers and how these factors may affect the outcome of the disease in patients with a history of cancer and their relatives.

NCT ID: NCT04183595 Recruiting - Mercury Poisoning Clinical Trials

NBMI Treatment in Patients With Mercury Toxicity

NBMI-Hg-COL
Start date: November 22, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

NBMI (N1, N3-Bis-(2-Mercaptoethyl) Isophthalamide) is a new metal chelator drug proposed as an alternative to the current chelators, and it is widely different; compared to the current chelators, consisting of two cysteamine molecules coupled to a single molecule of dicarboxybenzoate. It is used as a chelating agent and has the designation of an orphan drug, in the EU and USA; in the EU it is used for the treatment of mercury toxicity. It is freely soluble in solutions of dimethylformamide (DMF), dimethyl sulfoxide (DMSO) and sodium hydroxide diluted NaOH, slightly soluble in methanol and acetone, and insoluble in water. Pre-clinical data indicates low to no toxicity, and that it reduces the toxicity associated with acute exposure to Hg2+. No other chelator has been reported to prevent acute mercury toxicity with only one exposure to the chelator. It has the ability to penetrate cell membranes and cross the blood-brain barrier and chelate Hg2+ in a complex that eliminates the availability of Hg2+ and essentially eliminates toxic effects. The antioxidant properties of NBMI could also reduce the toxicity levels of hydroxyl free radicals immediately, upon entering cells suffering from oxidative stress. It is possible that the combined chelation of Hg2+ and the elimination of hydroxyl free radicals contribute significantly to the protective effects observed with the NBMI. Previous clinical studies conducted in subjects of the Phase I and Phase II a studies conducted, did not show significant adverse events in patients intoxicated with mercury, all patients who received the study medication have tolerated it well, with only mild or moderate adverse events reported; None of these were considered related to the pharmacological treatment of the study. In addition, there is no potential identified with safety problems in laboratory tests, or vital signs evaluations. The purpose of this Controlled Single-Center Double-Blind Crossover Clinical Trial Phase II b is to determine the efficacy, safety and tolerability of a 14 day 600mg / day of NBMI (N1, N2-bis-2-mercaptoethyl isophthalamide) Treatment, in the reduction of urinary mercury levels versus placebo, in accidentally exposed subjects to mercury in Colombia.

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04164810 Recruiting - Clinical trials for Spinal Cord Injuries

Effects of Hydrotherapy on Neuropathic Pain and Pain Catastrophization in Spinal Cord Injury

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

Spinal Cord Injury (SCI) is a spinal cord injury of traumatic origin with its main etiology being violence, which constitutes one of the greatest social and health problems worldwide. One of the complications with the greatest impact in people with SCI is Neuropathic Pain (NP). Pain, mainly chronic pain, has an effect on emotional states, cognition regarding pain and anticipation which leads to the catastrophization of the pain. This form of pain is related to chronic diseases that develop with pain of poor prognosis and are detrimental to quality of life therefore having enormous impacts on health systems. The physiological mechanisms of Hydrotherapy on pain are clear and there is evidence of its use in the management of painful syndromes of difficult treatments such as that for fibromyalgia and chronic lumbar pain, as well as its positive effect on pain perception. However, the effects of hydrotherapy on the NP of patients with SCI are unknown. Randomized, controlled clinical trial of parallel groups. A randomized sequence will be carried out in balanced blocks to assign the intervention (Hydrotherapy) or the control (Standard Physical Therapy), to a sample of 28 participants, 14 for each group. Each of the interventions (hydrotherapy and physical therapy) will last 9 weeks, for a total of 18 sessions (2 weekly sessions). Two measurements will be made, baseline (pre-intervention) and a second time one month after the end of the intervention. The validated Spanish scales will be used: NP-4 (NP Screening), Numerical Pain Scale (END), PCS (Pain Catastrophization), SF-36 (Health-related quality of life) and WHODAS 2.0 (Disability). The primary outcome is the level of NP and its catastrophization, and the secondary outcomes are level of disability and quality of life. With 28 participants fully measured, it is possible to have 80% power to find differences between the groups with respect to the primary outcomes. All information will be analyzed using average comparisons with 95% confidence. The analysis will be carried out by Intention to Treat (ITT) taking all the randomized participants. Missing data will be processed through multiple imputation chains. Generalized mixed linear models will be used comparing the standardized baseline and post-intervention averages of each group and between each group, obtaining 95% confidence intervals and p-values. Subgroup analysis will be performed adjusting confounders and interactions. A significant difference will be considered when the value of p is less than 0.05. Cohen´s D will be calculated to identify the size of the intervention effect. Discussion: The results will reflect the effect of the hydrotherapy on NP in patients with SCI. They will also permit the identification of potential changes in functionality levels or quality of life in the intervened population.

NCT ID: NCT04133649 Recruiting - Aging Clinical Trials

Evaluation of Safety and Tolerability of Libella Gene Therapy for the Treatment of Aging: AAV- hTERT

Start date: October 17, 2019
Phase: Phase 1
Study type: Interventional

Using gene therapy to express active telomerase (hTERT) in humans has the potential to treat many of the age related diseases, including Aging itself. This study will entail treating subjects with hTERT delivered via transduction using AAV. The goal is to extend the telomeres to prevent, delay, or even reverse Aging.

NCT ID: NCT04133454 Recruiting - Alzheimer Disease Clinical Trials

Evaluation of Safety and Tolerability of Libella Gene Therapy for Alzheimer's Disease: AAV- hTERT

Start date: October 10, 2019
Phase: Phase 1
Study type: Interventional

Using gene therapy to express active telomerase (hTERT) in human cells has the potential to treat many neurodegenerative diseases related to aging, including Alzheimer's disease (AD). This study will entail treating subjects with hTERT delivered via transduction using AAV. The goal is to extend the telomeres to prevent, delay, or even reverse the development of the pathology of AD. It is expected to have a direct consequence on cognitive function and quality of life in patients with neurodegenerative diseases, such as AD.

NCT ID: NCT04113044 Recruiting - Hip Fractures Clinical Trials

Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®

Start date: February 1, 2021
Phase:
Study type: Observational

Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups). Patients will be followed up according to the standard (routine) for up to 1 year after the treatment. Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.