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NCT ID: NCT03924466 Recruiting - Prostate Cancer Clinical Trials

Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients

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

Study objective: Cohort 1: To quantify the uptake of 68GaNOTA-Anti-HER2 VHH1 in local or distant metastases from breast carcinoma patients and to assess repeatability of the image-based HER2 quantification. The uptake will be correlated to results obtained via biopsy of the same lesion, if available. Cohort 2: To report on uptake of 68GaNOTA-Anti-HER2 VHH1 in different cancer types that might overexpress HER2 Cohort 3: To explore the feasibility and added value of 68GaNOTA-Anti-HER2 VHH1 in the neoadjuvant setting of HER2-expressing breast carcinoma Time schedule: After inclusion, patients will be injected intravenously with 37 - 185 MBq 68GaNOTA-Anti-HER2 VHH1 with a total mass of up to 200 μg NOTA-Anti-HER2 VHH1. Serum and plasma samples will be collected at injection. At 90 min after injection, a total body PET/CT scan will be performed. Patients in cohort 1 will undergo a second PET/CT procedure, identical to the first procedure, within 8 days, with a minimal interval of 18h and maximal interval of 8 days. Patients in cohort 2 can undergo an optional 18F-FDG-PET/CT within 21 days prior to or after 68GaNOTA-Anti-HER2 VHH1. In cohort 1 and 2, based on PET/CT images, up to 2 lesions will be selected for optional image-guided biopsy. Biopsy will be performed max. 28 days after the last PET/CT. Plasma and serum samples will be obtained between 60 and 365 days after first injection for patients in cohort 1 and between 42 and 365 days after first injection for patients in cohort 2. Patients in cohort 3 will undergo 68GaNOTA-Anti-HER2 VHH1 PET/CT prior to the start of neoadjuvant treatment and again after the last cycle of neoadjuvant treatment but prior to surgery. Plasma and serum samples will be obtained before each injection and between 42 and 365 days after the last injection.

NCT ID: NCT03925662 Recruiting - Colorectal Cancer Clinical Trials

Mebendazole as Adjuvant Treatment for Colon Cancer

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

mebendazole treating colon cancer

NCT ID: NCT03925701 Recruiting - dm Clinical Trials

Clinical Study Evaluating Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM

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

Clinical study evaluating vildagliptin versus vildagliptin/metformin on NAFLD with DM.

NCT ID: NCT03925714 Recruiting - DM Clinical Trials

Impact of P53 and SIRT1 in Type 2 Diabetes

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

Investigating the impact of p53 and SIRT1 in the development of type 2 DM

NCT ID: NCT03926091 Recruiting - Breast Cancer Clinical Trials

Study Comparing 4 Cycles With 6 Cycles of TC (Docetaxel+Cyclophosphamide) Adjuvant Chemotherapy for 1-3 Lymph Node Positive ER+/HER2- Early Breast Cancer

CLOVER
Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective, multisite, randomized, open-label Phase III clinical trial (CLOVER study) comparing 4 cycles with 6 cycles of TC (docetaxel+cyclophosphamide) adjuvant chemotherapy for 1-3 positive lymph node, ER+/HER2- early breast cancer patients.

NCT ID: NCT03926377 Recruiting - Osteoporosis Clinical Trials

Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid

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

Bullous pemphigoid is the most common type of bullous skin disease and is clinically characterized by clear-tense bullae, which result in post-bullous cutaneous erosions, altering the skin barrier. The treatment of this pathology consists of the application of high doses of topical corticosteroids (clobetasol propionate) for a prolonged period of at least 6 months. The main objective of this study is to demonstrate a change in bone mineral density at 6 months after initiation of treatment, in subjects with bullous pemphigoid and treated with topical corticosteroid.

NCT ID: NCT03926559 Recruiting - Perineal Tear Clinical Trials

The Effect of Neuraxial Morphine (Duramorph) on Pain Control

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

With the rise of the opioid epidemic, it is important for physicians to be more mindful of the amount of narcotic prescriptions that are being written every day. In the early postpartum period, pain and fatigue are the most common problems reported by women. Untreated pain has negative consequences on the amount of opioid narcotics used, postpartum depression, and the potential development of persistent chronic pain. While pain can interfere with a woman's ability to adequately take care of her newborn, narcotic abuse can lead to excessive maternal drowsiness and increased infant mortality in the new breastfeeding mother. The most common sources of pain after a vaginal delivery include breast engorgement, uterine contractions and perineal lacerations. Perineal lacerations are immediate postpartum complications of the vaginal birth process, defined as injury that involves the bulbocavernosum muscle complex (second degree), and may involve the anal sphincter complex (third degree) or the anal epithelium (fourth degree). Prevention of chronic and severe postpartum pain, especially after a cesarean delivery has been extensively studied, however, much paucity in research exists for the management of postpartum pain from perineal tears. Compared to patients with first degree tears or intact perineum, women with severe perineal lacerations (second degree or greater) have increased analgesic requirement up to the fifth postpartum day. . Epidural morphine has been accepted by anesthesiologists as treatment for acute pain. In obstetrics, 2-3 mg of epidural morphine was found to be sufficient to provide post-episiotomy analgesia. Neuraxial morphine has been used for analgesic management after a cesarean section, especially to reduce the amount of oral pain medications used in the first 24 hours, but limited data exists on the use of neuraxial morphine after a severe perineal laceration repair in the setting of a vaginal delivery. Niv et al (1994) studied the effect of epidural morphine and monitored its timing of administration in post-epiostomy pain onset. They noted that if epidural morphine is administered before the onset of pain in an episiotomy repair it is much more effective than if given after the onset. This study hopes to take the prior 1994 study a step further and incorporates it's data to investigate whether neuraxial morphine given after a severe perineal laceration repair mitigates postpartum pain.

NCT ID: NCT03926988 Recruiting - Clinical trials for Acute Ischemic Stroke

The Vesalio NeVa Stent Retriever Registry Study for Treatment of Large Vessel Occlusion Strokes

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

A prospective, open label, 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

NCT ID: NCT03933748 Recruiting - Clinical trials for Bacterial Infections

Therapeutic Drug Monitoring of Teicoplanin in Children

Start date: April 1, 2019
Phase:
Study type: Observational

In this study, the therapeutic drug monitoring of teicoplanin is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then we analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of teicoplanin in Chinese children.

NCT ID: NCT03935035 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Online PTSD Treatment for Young People and Carers - Case Series

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

Post Traumatic Stress Disorder (PTSD) is prevalent and impairing in children and young people. Effective face to face treatments exist, including Cognitive Therapy for PTSD (CT-PTSD), developed by the researchers' group. However, few young people access effective treatments. The researchers are therefore developing a website and smart-phone App that will improve accessibility of this treatment by allowing trained therapists to deliver CT-PTSD over the internet (iCT) to young people (12-17 years old) with PTSD. This study aims to provide an initial evaluation of iCT. This will be done by running an uncontrolled case series with 6 young people. The objectives of the case series are to: to gauge acceptability of the programme to young people, carers, and therapists; to measure adherence to the programme; to test the battery of measures for acceptability; and to obtain estimates of clinical change.