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NCT ID: NCT03154164 Completed - Cholecystolithiasis Clinical Trials

Study on the Learning Curve for Fundus First With Ultrasonic Tissue Coagulation in Elective Cholecystectomy

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

The present study aims at analyzing the learning curve for fundus first with the ultrasonic tissue coagulation dissection technique in elective cholecystectomy. Patients included in the study are planned for an elective cholecystectomy, on the basis of the gallstone disease. All participating surgeons have experience of the traditional approach with electrocautery. The operation time as well as the surgeons own evaluation of difficulty and performance are noted. Selected films are analyzed by independent surgeons with experience of the fundus first technique. The Swedish registry of gallstone surgery and ERCP (GallRiks) are used to record the intra and postoperative complication rate.

NCT ID: NCT03153111 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

SERENADE
Start date: July 11, 2017
Phase: Phase 2
Study type: Interventional

This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease. The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.

NCT ID: NCT03152721 Completed - Parkinson Disease Clinical Trials

The Effect of Parkinson Kinetigraph Recordings on the Management and Outcome in Parkinson's Disease

Start date: April 30, 2017
Phase: N/A
Study type: Interventional

With time most people with Parkinson's disease (PwP) develop fluctuations in motor symptoms in relation to medication intake. The prevalence may be both under and overestimated as it is based on history rather than observation. Patterns in fluctuations are difficult to determine and it has been demonstrated that every 30-minute diaries need to be kept for 10 days or more to safely represent fluctuation patterns. The Parkinson Kinetigraph (PKG) is an automated system that is carried passively and provides similar information after wearing the device for 6 days. Clinical experience is that most patients agree that results are representative to their experiences. It is not known if using the PKG routinely at any stage of PD will change management of the disease. The hypothesis of this study is that providing PKG information to neurologists will lead to a more active management that may improve outcome in PD patients.

NCT ID: NCT03152617 Recruiting - Obesity, Morbid Clinical Trials

BASUN - Risks for Malnutrition, Metabolic Bone Disease and Impaired Oral Health After Obesity Treatment

BASUN
Start date: April 2015
Phase:
Study type: Observational [Patient Registry]

Weight-reducing obesity surgery (OS) generally gives good results but complications are common; e.g. impaired weight loss, weight regain, bowel pain, diarrhea, vitamin/mineral deficiency, osteoporosis and impaired dental health. The BASUN study is a prospective 10-year comparison of 1000 surgically and 400 conventionally treated individuals regarding adverse side-effects, risk factors for complications and poor outcome.

NCT ID: NCT03152084 Terminated - Clinical trials for Diabetes Mellitus, Type 2

The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.

DAPASALT
Start date: July 12, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by Type 2 Diabetes Mellitus status and kidney function

NCT ID: NCT03151772 Terminated - Glioblastoma Clinical Trials

Bioavailability of Disulfiram and Metformin in Glioblastomas

INSIDE
Start date: January 29, 2018
Phase: Early Phase 1
Study type: Interventional

Neuro-oncological trials may fail due to the drug never getting to the intended target (i.e. within the tumor micro environment). Also, changes' occurring in tumor cells when removed from patients and grown in-vitro is another limiting factor influencing the clinical success. Important questions are therefore: 1. Does the drug get there? 2. Does the drug do what it is intended to do? To improve chances of clinical success there is a need for rational and intelligent selection of potential drugs in future trials. This is an initiative for analyzing tumor concentration of preoperative administered repurposed drugs

NCT ID: NCT03151629 Recruiting - Prostate Cancer Clinical Trials

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

IRONMAN
Start date: July 21, 2017
Phase:
Study type: Observational [Patient Registry]

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

NCT ID: NCT03151551 Completed - Psoriatic Arthritis Clinical Trials

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

SPIRIT-H2H
Start date: August 24, 2017
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

NCT ID: NCT03150147 Completed - Clinical trials for Transplant; Failure, Heart

A Randomized Controlled Trial Comparing Non-ischemic to Ischemic Preservation in Adult Cardiac Transplantation

NIHP
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The overall aim of this proposal is to compare a new state-of-the-art ex-vivo organ preservation method with standard ischemic cold static storage of donor hearts in adult cardiac transplantation. Standard heart preservation before transplantation consists of cold ischemic storage of the heart. Clinical studies has shown that the morbidity and mortality risk increases with extension of the allograft ischemic time over four hours. For each additional hour the mortality risk increase with 25% the first year. This time constrained is costly and results in severe logistical problems, leading to loss of transplantable organs. Initially the study is prospective, single-institution, open-label, non-randomised trial comparing the NIHP method with the conventionally SCS in adult heart transplanted patients at Skane University Hospital, Lund, Sweden. Six patients will be transplanted using the non-ischemic hypothermic cardioplegic perfusion. These will be compared with contemporary control patients transplanted with standard ischemic cold static storage. The results will be analysed and reported. After the initially six patients have been completed, the study will become a single center, prospective, open, blinded endpoint, randomized, controlled clinical trial including 34 patients. The primary end-point is a composite of mortality, primary graft dysfunction (PGD), need for extra corporal support, or acute cellular rejection (ACR) within 30- days post-transplant. PGD and ACR will be accessed blinded.An improved preservation of the transplanted organ will reduce the major limitations for survival in the early post-transplant period such as non-specific graft failure and acute rejection. Furthermore, it will make it possible to increase the donor pool.

NCT ID: NCT03147300 Completed - Low Back Pain Clinical Trials

Implementation of a Best Practice Primary Health Care Model for Low Back Pain

BetterBack
Start date: April 1, 2017
Phase: N/A
Study type: Interventional

POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In Sweden, primary care professionals require an evidenced based model of care for LBP. INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care for LBP. CONTROL: Current routine practice for LBP care before implementation of the BetterBack model of care. OUTCOME: Patient reported measures (function, activity, health), therapist reported measures (diagnosis, intervention, specialist referral, best practice self-confidence, determinants of implementation) and cost-effectiveness. AIM: To deliver best practice recommendations for LBP and study their most effective implementation through the BetterBack model of care. METHOD: A cluster randomised trial with dog leg design. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist outcomes as well as cost-effectiveness compared to current routine care.