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NCT ID: NCT03045133 Completed - Pain, Postoperative Clinical Trials

QUALITY OF RECOVERY AFTER INTRAOPERATIVE MORPHINE OR METHADONE

Start date: June 20, 2016
Phase: Phase 4
Study type: Interventional

Introduction. Despite the advantages associated with the use of remifentanil during total intravenous anesthesia (TIVA), it has been observed a frequent difficulty in the control of postoperative pain due to the risk of developing hyperalgesia and acute tolerance associated with the administration of this opioid. There is evidence that NMDA receptors are involved in the development of these changes. Methadone is an opioid that exhibits analgesic potency similar to that of morphine but has NMDA antagonist activity and longer duration of action as additional features. The objective of the study was to evaluate the quality of recovery (QoR40) of patients undergoing TIVA for laparoscopic cholecystectomy and who received morphine or methadone to control postoperative pain. Methods. Patients aged 18 to 65 years, physical status ASA I and II, submitted to total venous anesthesia (propofol and remifentanil) for laparoscopic cholecystectomy and eligible to participate in this prospective and randomized clinical study will be evaluated. After induction of anesthesia, patients will receive a solution containing 0.1 mg.kg-1 morphine (MF group) or 0.1 mg.kg-1 methadone (MT group). Data on the presence of pain, nausea, vomiting, tremor, drowsiness, presence of SpO2 <92%, even with O2 face mask (5 L.min-1) and length of stay will be recorded at PACU. The pain will be evaluated every 15 minutes on a verbal numerical scale (ENV) from 0 to 10. E.v. morphine 0.1 mg.kg-1 (MF group) or methadone 0.1 mg.kg-1 (MT group) will be administered every 15 minutes to obtain the score below 3. After discharge from the PACU, all patients will receive intravenous ketoprofen every 12 hours and dipyrone every 6 hours. For cases where the patient considers the analgesic regimen insufficient, tramadol (100 mg) will be administered intravenously at 8-hour intervals. The consumption of analgesics, the intensity of pain, the occurrence of nausea, vomiting and other complications in the ward will be recorded. The application of the questionnaire (QoR40) will be performed in the ward the morning after the surgery by a medical student.

NCT ID: NCT03045120 Completed - Clinical trials for Chronic Phase Chronic Myeloid Leukemia

Determining Change in Cardiovascular and Metabolic Risks in Patients With Chronic Phase Chronic Myeloid Leukemia Receiving BCR-ABL Tyrosine Kinase Inhibitor First-Line Therapy in the United States

Start date: July 19, 2017
Phase:
Study type: Observational

This non-interventional, prospective study will characterize the impact of three approved first and second generation BCR-ABL1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase CML (CP-CML) patients who are TKI naive and initiating first-line TKIs in routine clinical practice in the US. All treatment decisions will be determined at the discretion of the treating physician(s) and data identifying the cardiovascular and metabolic risk factors will be collected. Additional fasting blood samples (collected following 8 hours of fasting) will be collected during standard of care (SOC)/routine office visits. Additional research imaging will be performed and will be reviewed by core imaging laboratory. As the study is collecting data on management of CML, this study will not influence the prescribing or management practices at participating sites.

NCT ID: NCT03044782 Completed - Clinical trials for Central Centrifugal Cicatricial Alopecia

Barriers to Care and QOL for CCCA Patients

Start date: August 2016
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of the current project is twofold; first to determine what personal, historical, logistical, and environmental factors preclude women from obtaining medical care for CCCA hair loss. Because damage from CCCA is irreversible, early identification and treatment is paramount to limiting the negative ramifications of the disease. Second, to investigate how CCCA hair loss, a common occurrence in the Black population, can be a significant psychological impediment to lives of affected Black women. Based on previous research on the psychosocial impact of generalized hair loss in Black women, it is fair to consider that CCCA hair loss also leads to problems with self-esteem and participation in daily life activities. This research, the first of its kind, will add to existing knowledge of CCCA by investigating the quality of life and barriers to care of patients with this condition. The goal of this study is to illuminate what stands in the way of secondary and tertiary prevention of CCCA patients and tailor treatment strategies to address their needs. The results of this study will be instrumental in modifying dermatology resident training, adding to existing dermatology management guidelines, and even developing public health advocacy programming.

NCT ID: NCT03044626 Completed - Clinical trials for Nonsmall Cell Lung Cancer

Fostering Efficacy of Anti - PD-1 - Treatment: Nivolumab Plus Radiotherapy in Advanced NSCLC

FORCE
Start date: February 10, 2017
Phase: Phase 2
Study type: Interventional

AIO-YMO/TRK-0415 (FORCE) is a Phase 2, open-label of nivolumab, patients with metastatic non-squamous NSCLC with the necessity of radiotherapy of a metastatic site (e.g. bone) in 2nd-line or 3rd-line treatment for study group A and patients with metastatic non-squamous NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment for study Group B.

NCT ID: NCT03044366 Completed - Clinical trials for Anesthesia Management of Premature Infants

General Anesthesia Management in 15 Preterm Infant

Start date: December 2016
Phase: N/A
Study type: Observational

Anesthesia management of preterm infants is challenging for the anesthesiologist. Because of rudimentary build, many medical and physical problems have shown in treatment of disease such as complications, airway problems, temperature disregulation and deficient drug metabolism. This retrospective study evaluates the perioperative management and postoperative course in premature infants undergoing diode laser photocoagulation (DLP) for retinopathy of prematurity (ROP).

NCT ID: NCT03044236 Completed - Clinical trials for Glenohumeral Internal Rotation Deficits

Effect of a Novel Stretching Technique on Shoulder Range of Motion and Voluntary Contraction in Overhead Athletes With Glenohumeral Internal Rotation Deficits "GIRD"

GIRD
Start date: April 19, 2017
Phase: N/A
Study type: Interventional

To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study.

NCT ID: NCT03044197 Completed - Prostate Cancer Clinical Trials

Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

Start date: July 25, 2017
Phase: N/A
Study type: Interventional

Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of increasing the detection of detecting clinically significant prostate cancer (csPCa) while decreasing the detection of non-significant PCa.

NCT ID: NCT03044158 Completed - Clinical trials for Tuberculosis, Pulmonary

GeneXpert Performance Evaluation for Linkage to Tuberculosis Care

XPEL-TB
Start date: October 22, 2018
Phase: N/A
Study type: Interventional

The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing. The intervention strategy was developed based on theory-informed assessment of barriers to TB diagnostic evaluation at community health centers in Uganda and a process of engagement with local stakeholders. It includes: 1) Point-of-care molecular testing using GeneXpert as a replacement for sputum smear microscopy; 2) Re-structuring of clinic-level procedures to facilitate same-day TB diagnosis and treatment; and 3) Quarterly feedback of TB evaluation metrics to health center staff. The investigators' central hypothesis is that the intervention strategy will have high uptake and increase the number of patients diagnosed with and treated for active pulmonary TB. To test this hypothesis, the investigators will conduct a pragmatic cluster-randomized trial at community health centers that provide TB microscopy services in Uganda in partnership with the National TB Program (NTP). The investigators utilize an effectiveness-implementation hybrid design in which, concurrent with the clinical trial, the investigators will conduct nested mixed methods, health economic and modeling studies to assess 1) whether the intervention strategy modifies targeted barriers to TB diagnostic evaluation; 2) fidelity of implementation of the intervention components (i.e, the degree to which intervention components were implemented as intended vs. adapted across sites); and 3) cost-effectiveness and public health impact.

NCT ID: NCT03044080 Completed - Clinical trials for Stroke Rehabilitation

Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot

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

Clinical randomized clinical trial to assess the effectiveness on walking speed of repeated use of botulinum neurotoxin type A (BoNT/A)in the post-stroke spastic equinovarus foot in three successive infiltrations at 6-month intervals, checking if the sustainability of the effect is greater in incobotulinumtoxin A (Xeomin®) than in onabotulinumtoxinA (Botox®).

NCT ID: NCT03043937 Completed - Clinical trials for Heart Disease Structural Disorder Abscess of Cardiac Septum

Cardiac Diseases With Pregnancy in Benisuef Localities

Start date: January 2015
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this work is to demonstrate the variation of cardiac diseases among pregnant ladies in our localities, detect maternal & fetal complications and to predict the risk factors for poor maternal, fetal & neonatal outcomes