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NCT ID: NCT03202134 Completed - Clinical trials for Major and Minor Surgical Complications

Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery

DIEPflap
Start date: January 2014
Phase:
Study type: Observational [Patient Registry]

The Deep Inferior Epigastric Perforator free flap (DIEPflap) involves the transfer of abdominal tissue to the breast using microsurgery. Flap failure is rare today, but is devastating. Blood flow in a DIEPflap decreases during the first hours. Many anesthetic factors like low cardiac output, hypothermia and surgical stress cause vasoconstriction or thrombosis. A stable anesthesia during these long procedures improves flap perfusion. Postoperative nausea and vomiting (PONV) is frequent and might have an impact. Opioid free anesthesia (OFA) reduces PONV. The anti-inflammatory and vasodilator effects of the drugs dexmedetomidine and lidocaine might improve free flap perfusion. The primary outcome counted all complications. The secondary outcomes were PONV, pain, opioid consumption, skin flap temperature and length of hospital stay. Patients get according to attending anesthesiologist an opioid or opioid free anesthesia without any randomization but based on availability of competence.

NCT ID: NCT03202030 Completed - Clinical trials for Fresh Sockets With Buccal Resorption

Immediate Dentoalveolar Restoration Compared to Bio-oss

IDRBio-oss
Start date: January 2016
Phase: N/A
Study type: Interventional

This randomised controlled trial compares the immediate dentoalveolar restoration and bovine demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A total of 34 patients will be included and followed clinically and radiographically for 18 months. Patient centred outcomes will also be evaluated.

NCT ID: NCT03201458 Completed - Clinical trials for Gallbladder Carcinoma

Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer

Start date: February 8, 2018
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well atezolizumab with or without cobimetinib works in treating patients with bile duct cancer that has spread to other places in the body (metastatic) and cannot be removed by surgery (unresectable) or gallbladder cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving atezolizumab with cobimetinib may work better at treating patients with bile duct and gallbladder cancer.

NCT ID: NCT03201289 Completed - Clinical trials for Postoperative Complications

Microvolt T-wave Alternans in Cardiac Surgery Patients

Start date: January 2013
Phase: N/A
Study type: Observational

The purpose of this study is to measure MTWA in the patients undergoing cardiac surgery and to investigate the relation between MTWA and adverse clinical outcomes.

NCT ID: NCT03201263 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Sigh in Acute Hypoxemic Respiratory Failure

PROTECTION
Start date: December 20, 2017
Phase: N/A
Study type: Interventional

Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016). Early implementation of a specific mechanical ventilation mode that enhances lung protection in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a tremendous impact on clinical practice. Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to assisted mechanical ventilation: improves oxygenation without increasing ventilation pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure; improves regional compliances. Thus, physiologic studies generated the hypothesis that addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung strain and stress through various synergic mechanisms potentially yielding decreased risk of VILI, faster weaning and improved clinical outcomes. The investigators conceived a pilot RCT to verify clinical feasibility of the addition of Sigh to PSV in comparison to standard PSV. The investigators will enrol 258 intubated spontaneously breathing patients with mild to moderate AHRF and ARDS admitted to the ICU. Patients will be randomized through an online automatic centralized and computerized system to the following study groups (1:1 ratio): - PSV group: will be treated by protective PSV settings until day 28 or death or performance of spontaneous breathing trial (SBT); - PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh until day 28 or death or performance of spontaneous breathing trial (SBT). Indications on ventilation settings, weaning, spontaneous breathing trial and rescue treatment will be specified.

NCT ID: NCT03201172 Completed - Clinical trials for Unicompartmental Knee Arthroplasty

Univation® X Follow-Up Study

Start date: September 25, 2017
Phase:
Study type: Observational

The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design. The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

NCT ID: NCT03201029 Completed - Clinical trials for Characteristics of Dermatologists Who Focus on Ethnic Skin

Assessment of Dermatologists at Skin of Color Clinics

Start date: July 1, 2017
Phase: N/A
Study type: Observational

As a physician, narrowing ones' practice to a particular pathology or group of people is common. Dermatologists are able to concentrate within a number of different areas: cancer, cosmetics, pediatrics or ethnic populations to name a few. Recently, there has been an emphasis on developing skin of color (SOC) clinics and recruiting dermatologists who focus on skin diseases that effect patients with skin of color. In this study, patients with SOC is defined to encompass that of persons of African, Asian, Native American, Middle Eastern, and Hispanic backgrounds. An emphasis on SOC benefits patients in a variety of ways: 1) these dermatologists are trained to recognize pathology that may present differently, depending on the Fitzpatrick skin type and ethnicity of the patient, 2) these dermatologists are trained to address medical disparities that are present among patients with SOC, 3) these dermatologists are trained to address culturally sensitive topics that may be common among patients with SOC. Despite the growing number of SOC patients and the benefit that SOC clinics provide, studies have not looked at the characteristics that influence dermatologists to focus on SOC as opposed to other specialty areas. Therefore, we aim to identify information that may influence dermatologists to focus on skin disease prevalent among patients with SOC. Currently, there are nine academic institutions with an Ethnic Skin Center in the United States. Given the limited number of academic centers with a designated center focused on SOC, a lot of care of skin of color patients happens in private practices. This is supported by the fact that many of the members in the Skin of Color Society are dermatologists in private practices. Thus, SOC clinic is defined broadly in our study to encompass not only academic dermatologists but also private practice dermatologists who have special interest in care of skin of color patients. Regardless of the type of practice, we hope to identify unique characteristics of dermatologists focusing on SOC skin diseases.

NCT ID: NCT03200860 Completed - Clinical trials for Heart Failure,Congestive

Effects of Empagliflozin on Clinical Outcomes in Patients With Acute Decompensated Heart Failure

EMPA-RESPONSE
Start date: December 18, 2017
Phase: Phase 2
Study type: Interventional

Acute decompensated heart failure is the fastest growing disease in the world and the leading cause of hospital admissions worldwide. Short term mortality and rehospitalization are extremely high (20-30% within 3-6 months) and there is no therapy available that improves clinical outcome in these patients. Empagliflozin is a selective inhibitor of sodium glucose co-transporter with diuretic and renal- protective properties. In patients with type 2 diabetes at high risk for cardiovascular events, empagliflozin reduced the risk of hospitalization for heart failure by 35%. Based on the promising pharmacological profile of empagliflozin in relation to the needs for treatment of acute decompensated heart failure, we hypothesize that empagliflozin exerts positive effects in acute decompensated heart failure, with or without diabetes, This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study in subjects admitted for acute decompensated heart failure. Eighty eligible subjects will be randomized in a 1:1 ratio to receive either empagliflozin 10 mg/day or matched placebo.

NCT ID: NCT03200808 Completed - Clinical trials for Nonneoplastic Epithelial Disorders of Vulva

Methylene Blue Injection for Nonneoplastic Epithelial Disorders of Vulva

NNEDsMB
Start date: October 1, 2013
Phase: Phase 1
Study type: Interventional

The aim of this study is to demonstrate the safety and effectiveness of mixed methylene blue compound Injection for the treatment of nonneoplastic epithelial disorders(NNEDS) of vulva. NNEDS of skin and mucosa of vulva refer to a group of chronic diseases including squamous hyperplasia and lichen sclerosus, which mainly cause vulvar itching and hypopigmentation. Usually the itching is severe may influence social activities and sleep. In addition, NNEDS cause scarring of the vulva which may cause significant sexual dysfunction or pain. The reasons for NNEDs are not clear and the methods of treatment are diverse. The current treatments are primarily local drug (e.g. steroid, calcineurin inhibitors, immunosuppressive agents ), surgical treatments, laser or photodynamic therapy, and the "gold standard" treatment for lichen sclerosus is potent steroids creams. However, all the treatments are not good enough, and the diseases often recur and severely affect women's quality of life. So the investigators reviewed plenty of literatures, and found some authors used single intradermal 1% methylene blue injection for intractable idiopathic pruritus ani and the effect was good. As a preliminary experiment, the investigators used intradermal mixed methylene blue compound injection for a NNEDs patient in the year of 2012, the itching of the patient stopped immediately and the color of the vulva recovered 6 months later. The patient keeps healthy till now. And from then on, the investigators designed this study and to verify the effect and complications of intradermal mixed methylene blue compound injection for the treatment of NNEDS. So far, there is no similar study reported internationally.

NCT ID: NCT03200665 Completed - Clinical trials for Condition of Fetal Growth or Malnutrition (Diagnosis)

Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy: a Randomized Trial

Start date: July 2015
Phase: N/A
Study type: Interventional

Sonographic fetal weight estimation at the last weeks of third trimester in low-risk pregnancies is an effective method for diagnosis of fetal growth restriction (FGR) permitting close surveillance and timely delivery. The need for a systematic ultrasound evaluation at the last weeks of a low-risk pregnancy and the best time to perform it remains controversial. The most commonly used clinical screening tool in this population is the serial measurement of symphysis-fundus distance, which is a method of a variable and low sensitivity for detection of FGR. In Portugal, in accordance with guidelines of Direcção Geral de Saúde from 2015, fetal growth restriction screening in low risk pregnancies is performed with an ultrasound for fetal weight estimation at 30th-33rd weeks. Nonetheless, recent data from randomized trials showed that FGR detection rate was superior at 36 vs 32 weeks' gestation. In cases of severe FGR, detection rate was also superior at 36 vs 32 weeks' gestation. In a prior retrospective study, our group analyzed 1429 term low risk pregnancies and the investigators concluded that small for gestational age term babies (birthweight < 10th centile) had a statistically significant higher rate of operative deliveries for intrapartum fetal distress than appropriate for gestational age as well as a higher rate of admission to neonatal intensive care unit. Moreover the investigators compared the same outcomes within small for gestational age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected (normal 30th-33rd weeks ultrasound). Antepartum detection of small for gestational age neonates showed a statistically significant lower rate of operative deliveries for intrapartum fetal distress than undetected small for gestational age neonates. The investigators will conduct a prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the standard of care ultrasound in low risk pregnancies is effective in improving the detection rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission to neonatal intensive care unit.