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NCT ID: NCT03737643 Not yet recruiting - Clinical trials for Advanced Ovarian Cancer

Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients.

DUO-O
Start date: December 20, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

NCT ID: NCT03737071 Not yet recruiting - Fatty Liver Clinical Trials

The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes

Start date: November 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to examine whether a low carbohydrate diet decreases hepatic lipid content and changes hepatic mitochondrial flux in humans.

NCT ID: NCT03734211 Not yet recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients

EVOLVD
Start date: November 1, 2018
Phase: Phase 3
Study type: Interventional

The main goal of this study is to evaluate the effect of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab on cardiac allograft vasculopathy in de novo heart transplant recipients. Secondary objectives are to assess the impact of treatment on: i) cholesterol levels, ii) renal function, iii) inflammation, iv) quality of life, v) cardiac function as assessed by biomarkers and echocardiography, vi) the number of rejections, and (vii) safety and tolerability. As an exploratory outcome, the investigators will asses the effect of treatment on clinical events (death, myocardial infarction, cerebral stroke, cancer, end stage renal disease).

NCT ID: NCT03732131 Recruiting - Clinical trials for Faecal Microbiota Transplantation

The Finnish Faecal Microbiota Transplantation Study (FINFMT)

FINFMT
Start date: October 18, 2018
Phase:
Study type: Observational

The objective of the study is to follow up the long term effects of faecal microbiota tranplantation (FMT). All the over 18 years old patients receiving FMT and not included in other trials meet inclusion criteria to this study. Patients will be asked for a written consent. The outcome and possible side effects of the FMT will be followed by blood and feces samples for one year and with questionaires up to ten years after the FMT.

NCT ID: NCT03730610 Enrolling by invitation - Obesity Clinical Trials

Systemic Cross-talk Between Brain, Gut, and Peripheral Tissues in Glucose Homeostasis: Effects of Exercise Training

CROSSYS
Start date: January 2019
Phase: N/A
Study type: Interventional

Obesity and insulin resistance are worldwide epidemic and taking a major public health toll. Obesity also increases the risk for cognitive impairment which is also an increasing medical, societal, and economic challenge. The ultimate goal of this proposal is to develop a statistical model to assess systemic cross-talk between brain, peripheral tissues, gut microbiota and glucose metabolism. Integrated with exercise training intervention the results will be utilized to provide disease risk profiling and personalized predictions of exercise training as a drug free treatment for insulin resistance and type 2 diabetes.

NCT ID: NCT03729947 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

CLOSED SUCTION DRAIN VS. NO DRAIN IN ADOLESCENTS UNDERGOING PEDICLE SCREW INSTRUMENTATION FOR IDIOPATHIC SCOLIOSIS (DAISY 2018). A Randomized Clinical Trial

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

Abstract Background - Closed suction drain is typically used worldwide after instrumented posterior spinal fusion for adolescent idiopathic scoliosis (AIS). Postoperative drain leakage has been associated with up to 50% of total blood loss in these patients. Previous studies on adult patients with degenerative lumbar spine disorders have shown that leaving out subfascial drain does not increase the risk of deep wound infection or epidural hematoma. However, there has been no studies evaluating the need for subfascial drain in adolescents undergoing instrumented spinal fusion for idiopathic scoliosis. Study Design - A randomized, multicenter clinical trial on children and adolescents undergoing posterior spinal fusion for idiopathic scoliosis using pedicle screw technique. Sixty consecutive adolescents will be randomized into drain vs. no drain group at the time of wound closure using the sealed envelope technique (1:1). Aims and hypothesis - To compare drain vs. no drain use groups for the change in postoperative hemoglobin or hematocrit in children undergoing posterior spinal fusion for AIS. We hypothesize that postoperative hemoglobin change will be larger in the group receiving subfascial drain and there will no change in the risk of postoperative complications (deep surgical site infection, need for hematoma evacuation or other re-operation) between the study groups. Inclusion criteria - Adolescents (aged 10 to 21 years of age) undergoing surgery for idiopathic scoliosis using pedicle screw technique. Exclusion criteria - Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery. Main outcome parametres - Postoperative change in hemoglobin or hematocrit; Secondary parametres: need for blood transfusion, need for re-operation, need for change in the dressings. Ethical aspects - Ethical committee approval will be obtained both in Finland and in Sweden. An informed consent will be obtained from all children and their parents. In case of major intraoperative blood loss (>50% of blood volume) a subfascial drain can be inserted based on the decision of the treating physician. Time schedule and budget - This study will be started after ethical committee approval (estimated 10/2018). There will be no extra costs as all information gathered will be part of normal surgical treatment of AIS. A part-time research nurse has been hired to take care of data collection into the database.

NCT ID: NCT03729219 Recruiting - Diarrhea Clinical Trials

Prevention of Diarrheal Disease Due to Infection With Enterotoxigenic E. Coli (ETEC)

Start date: June 12, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase II b, double-blind, randomized, placebo-controlled study in healthy adults (age 18-65 years) to evaluate the safety, immunogenicity, different diagnostic tools and efficacy of ETVAX. Participants will travel to Grand Popo, Africa for 12 days. Prior travelling participants will be vaccinated with two doses of vaccine or placebo. Vaccine Preventable Outcome will be identified and then characterized as to incidence, duration, severity and frequency of Moderate or Severe Travellers diarrhea. Health related information and assessments will be recorded during the travel.

NCT ID: NCT03726645 Enrolling by invitation - Clinical trials for Ankylosing Spondylitis

The Effect of Fecal Microbiota Transplantation in Ankylosing Spondylitis (AS) Patients.

ASGUT
Start date: October 24, 2018
Phase: Early Phase 1
Study type: Interventional

Ankylosing spondylitis (AS) patients often have subclinical gut wall inflammation. Gut dysbiosis has been associated with both AS and Crohn disease, both of which have several features in common. Gut dysbiosis is associated with specific microbial profile in AS patients. Fecal microbiota transplantation (FMT) has been proved to be safe and effective treatment for recurrent Clostridium difficile infection, and the change in gut microbiota is shown to be long lasting. It has led to interest to study its effect on different inflammatory conditions associated with gut dysbiosis. We hypothesize that dysbiosis in AS leads to inflammasome overactivation on gut mucosa. We aim to study the role of gut inflammation, gut microbiota and inflammasome activation in pathogenesis of AS, and the effect of FMT on these factors, as well as clinical activity, in AS patients.

NCT ID: NCT03724747 Not yet recruiting - Clinical trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Anti-tumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Metastatic Castration Resistant Prostate Cancer

Start date: October 31, 2018
Phase: Phase 1
Study type: Interventional

The study medication (BAY 2315497 Injection) is a thorium-227 labeled immuno-conjugate, specific for the prostate-specific membrane antigen (PSMA), which will be evaluated in patients with metastatic castration resistant prostate cancer. In this study, this investigational medication will be administered to patients for the first time. The primary objective of the study is to define the safety and tolerability profile and Maximal Tolerated Dose (MTD) of BAY 2315497 Injection. The secondary objectives are to determine the recommended dose for further clinical development and to investigate how the study drug is distributed and cleared from the body.

NCT ID: NCT03721601 Completed - Stroke Clinical Trials

Novel Methods for Arrhythmia Detection: Preliminary Study

Start date: May 1, 2017
Phase:
Study type: Observational

Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making its detection a clinical challenge. Currently the golden standard for diagnosis of AF is by 12-lead electrocardiogram (ECG) or any other ECG-strip. The aim of the study is to assess the potential of chest strap as an ECG monitor, especially in arrhythmia detection by cardiologist and algorithm.