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NCT ID: NCT05964764 Recruiting - Clinical trials for Brain Injuries, Traumatic

Validation of the Scandinavian Guidelines for Minor and Moderate Head Trauma in Children

SHIPP
Start date: April 1, 2018
Phase:
Study type: Observational [Patient Registry]

Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed. The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department. The main research question is: - Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes? Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group. The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records >1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (>6 months).

NCT ID: NCT06093022 Recruiting - Breast Cancer Clinical Trials

Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study

SurMed-BCLM
Start date: April 1, 2018
Phase:
Study type: Observational [Patient Registry]

The liver represents the third most common site of breast cancer (BC) metastases behind the lymphatics and bone. The primary treatment for BCLM remains chemo-therapy and, more recently, targeted immunotherapy. The role of liver resection in BCLM remains controversial. The primary aim of the study is to compare the efficacy of liver resection vs. medical therapy alone in Breast Cancer Liver Metastasis (BCLM) patients.

NCT ID: NCT02707497 Recruiting - Sepsis Clinical Trials

The Effect of REcombinant Human Thrombopoietin (rhTPO) on Sepsis Patients With aCUte Severe thrombocytopEnia

RESCUE
Start date: April 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether recombinant human thrombopoietin(rhTPO) can rapidly increase the platelets counts, shorten the time of the platelet returned to normal, reduce platelet transfusion and bleeding events, prompt recovery of organ function, decrease the length of ICU stay, and eventually reduce the 28-day mortality in sepsis patients with severe thrombocytopenia.

NCT ID: NCT03150225 Recruiting - Clinical trials for Erectile Dysfunction

Physical Exercise for Men With Andropause

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

The aim of this study is to analyze the impact of physical exercise through a protocol of concurrent training in the psychological, physical, hormonal and sexual aspects in middle aged men with androgen deficiency in the aging male (ADAM). The study design with randomized clinical trial, comprising men in middle age (40 to 59 years) with ADAM, should be divided into two groups: 1) Control group (CG); 2) Experimental group (EG). Information related to sociodemographic and clinical profile will be collected; Psychological aspects (depressive and anxiety symptoms - Hospital Anxiety and Depression Scale ; stress - Perceived Stress Scale); Physical acpects (IMC; Percentage of body fat; Abdominal obesity - waist circumference in cm; Muscle strength - Biodex System 4 PRO isokinetic dynamometer; cardiorespiratory Fitness - Cycle-ergometer - CASE ECG Stress Testing System, General Electric Medical Systems, Milwaukee, WI); Hormonal aspects (total and free testosterone - blood collection); Sexual Aspect (Sexual satisfaction- International Index of Erectile Function); DAEM (scale of symptoms of aging). Apply a physical exercise protocol using the functional training method over a six-month period. All information will be collected before and after the intervention period. For statistical analysis, use the SPSS statistical package, version 20.0. (Kolmogorov-Smirnov or Shapiro-Wilk test) for the selection of statistical tests.

NCT ID: NCT03417453 Recruiting - Cataract Clinical Trials

Eye Drop Dispensers: Safety, Efficacy and Comfort.

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

One aspect to eye drop adherence is successful instillation of the drops; however, it is well known that many patients struggle with this task. Difficulties may include aiming their drops,extending their neck, preventing excess drop leakage, avoiding contamination of the bottle tip and generating enough force to expel a drop from the bottle. Instillation aids are devices that aim to ameliorate one or more of these barriers. Several eye drop dispensers had been developed in order to improved outcomes of eye drop instillation, including improved rates of successful administration and increased patient satisfaction compared to standard eye drop bottles. In this study we aim to compare the eye drops various installation aids

NCT ID: NCT03446365 Recruiting - Asthma Clinical Trials

Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools

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

Health disparities in pediatric asthma persist, with Latino children demonstrating increased asthma morbidity. Middle school children with asthma have greater morbidity than children from any other age group and spend a majority of their day in school, where they must manage any asthma. The investigators developed and piloted a novel group-based intervention - ASMAS (Asthma Self-MAnagement in Schools) in two geographic areas with a high prevalence of urban and Latino children with asthma: Providence, Rhode Island, and San Juan, Puerto Rico. ASMAS is a 4-session, peer-facilitated asthma self-management intervention specific to the school setting for Latino middle school (6th-8th graders) children. It is delivered by trained High School Juniors and Seniors of Latino descent with asthma. The preliminary effects of ASMAS for improving asthma outcomes and self-management relative to controls were demonstrated in a previous intervention development study. This study will evaluate ASMAS through a large-scaled Randomized Control Trial with urban middle school students who have persistent asthma in Providence, Rhode Island and San Juan, Puerto Rico and will identify barriers and facilitators to the implementation of ASMAS. These results will inform future, large-scale dissemination in other urban school settings.

NCT ID: NCT03475524 Recruiting - Melasma Clinical Trials

USE THE SYSTEMIC METFORMIN IN MELASMA

Start date: April 1, 2019
Phase: Phase 4
Study type: Interventional

Melasma is a chronic and relapsing acquired dyschromia due to an increased epidermal-melanin unit activity that affects sun-exposed areas mainly in women throughout the reproductive years. It is more common in women, accounting for 90% of all cases.The majority of patients are in third and fourth decades of their life. There are several risk factors that influence its appearance including genetic predisposition,exposure to heat and UV radiation, pregnancy, and exogenous hormones (such as oral contraceptives,thyroid hormones, and hormone replacement therapy). Other factors implicated are phototoxic drugs, anticonvulsant medications,and the use of certain cosmetics. Types of melasma are epidermal, dermal and mixed according to location of melanin.

NCT ID: NCT03476941 Recruiting - Abdominal Abscess Clinical Trials

Antibiotic Irrigations for Intra-Abdominal Drains

AID
Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

Intra-abdominal abscesses are pus-filled pouches in the abdominal cavity. Current standard of care includes drain placement in the abscess cavity to reach source control as well as administration of systemic antibiotics. It is common practice to flush the drain on a daily basis to ensure patency. This study aims to analyze the clinical impact of a higher local concentration of antibiotics (rather than normal saline) provided through drain irrigation with an antimicrobial agent (Gentamicin and/or Clindamycin) compare to normal saline.

NCT ID: NCT03556774 Recruiting - Smoking Abstinence Clinical Trials

Boosting Chinese Healthcare Service Providers' Utilization of Smoking Cessation Interventions by 'WeChat WeQuit' Program

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

In this single-blind, randomized trial, undertaken in China with 8-week interventions and follow-up to 52 weeks, about 2,200 providers will be randomly allocated to the intervention or control group.

NCT ID: NCT03557840 Recruiting - Infection Clinical Trials

Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients

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

Multidrug resistance towards Gram-negative pathogens makes essential the re-examination of older compounds. Temocillin is a penicillin originally marketed in the 1980s but then largely abandoned. It, however, shows a marked ß-lactamase stability (including most classical and extended-spectrum TEM, SHV, CTX-M enzymes and AmpC ß-lactamase). Temocillin is approved for the treatment of bacterial infections of the chest, the lungs, the kidney, the bladder, as well as bacterial infections of the bloodstream and wound infections. Temocillin efficacy depends primarily from the time interval during which the unbound plasma concentration remains above the minimal inhibitory concentration (MIC) of the antibiotic against the target organism(s). Unfortunately, no comprehensive pharmacokinetic data are available in non-critically-ill patients. The primary objective of the study is characterize the pharmacokinetics of total and unbound temocillin in non-ICU patients, and, on this basis, to propose optimized dosage regimens in this population. The secondary objectives are (i) to look for possible correlations between the plasma protein profile and the unbound temocillin concentrations; (ii) to investigate the impact of the level and nature of circulating plasma proteins on the unbound temocillin concentration. The study will be non-randomized, uncontrolled, prospective, open label, interventional, and monocentric. It will include a population pharmacokinetic-pharmacodynamic analysis of the data obtained. The study will enroll patients ≥ 18 years in need of a treatment with temocillin for (i) complicated urinary tract infection and pyelonephritis (associated or not with bacteremia), or (ii) lower respiratory tract infection, or (iii) abdominal infection, and requiring ≥ 4 days of hospitalization. Blood samples will be obtained at day 0 (control) and after 2 and 4 days of drug treatment (full pharmacokinetic evaluation over 8 to 12 h post-administration). Total and unbound temocillin concentrations in plasma will be quantified by a validated analytical method. A population pharmacokinetic/pharmacodynamics model of plasma total and unbound concentrations of temocillin will be obtained by Bayesian algorithms using Pmetrics software, driven by the predicted plasma total and unbound concentration. The model will be used to assess the probability of target attainment of temocillin.