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NCT ID: NCT03530241 Withdrawn - Clinical trials for Gall Stones, Common Bile Duct

Fluorescent Cholangiography and Bile Duct Stones

Start date: March 25, 2019
Phase: N/A
Study type: Interventional

Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection. Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order. Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.

NCT ID: NCT03504566 Withdrawn - Clinical trials for Diabetic Nephropathy Type 2

Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2)

ROTATE-2
Start date: November 15, 2017
Phase: Phase 4
Study type: Interventional

This project is an intervention study where type 2 diabetic patients will rotate through 4 different albuminuria lowering drugs with the aim to 1) quantify the individual relationship between drug exposure and albumin lowering response of different albuminuria lowering drugs in type 1 and type 2 diabetics; and 2) to investigate the effect of the same drug intervention on the glycocalyx layer in blood vessels. The overall purpose of this study is to allow for future personalized treatment of diabetics with regards to treating kidney disease more effectively than current standardized strategies.

NCT ID: NCT03428763 Withdrawn - Clinical trials for Arthritis, Rheumatoid

ELECTOR Treat-to-target Via Home-based Disease Activity Monitoring of Patients With Rheumatoid Arthritis

Start date: August 18, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to explore whether the effectiveness of home-based disease activity monitoring via a home-based (eHealth) intervention is superior to standard clinical disease activity assessment in obtaining and maintaining a low(er) disease activity in patients with rheumatoid arthritis (RA).

NCT ID: NCT03390413 Withdrawn - Renal Cancer Clinical Trials

Robot-assisted Surgical Resection vs. Cryoablation of Localised Renal Cancer

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

The present study is a randomized clinical trial which investigates robot-assisted partial nephrectomy (RPN) compared to image-guided cryoablation (CA) in a number of functional, oncological and economic variables. Every year close to 1000 Danes are diagnosed with renal cell carcinoma. Approximately 25% of these newly diagnosed patients have a T1a tumour, thus being candidates to nephron-sparing surgery. Today most nephronsparing surgical procedures consists of RPN, often requiring temporary clamping of the renal artery rendering the kidney to a critical period of warm ischemia which is potentially harmful to the renal function. Image guided ablative modalities has emerged as a minimal-invasive alternative to partial nephrectomy. The level of evidence within this domain is considered to be low as the existing literature is highly influenced by selection bias, and as of yet no randomized trial has compared the two modalities. Especially with the increasing age of the patients, an approach suitable for local anaestesia is desirable. Patients from Central Denmark Region and Region of Southern Denmark who are diagnosed with a pT1a renal cell carcinoma that is found to be eligible for both modalities will be offered to enter into a randomized trial to be treated with either RPN og CA. The study's primary endpoint is loss of renal function 6 and 12 month after treatment. Secondary endpoint includes recurrence free survival 1, 3 and 5 years after treatment, readmission and complication rates as well as health economic evaluations. All patients will be pre- and postoperatively assessed with biochemistry, CT urography, CT thorax and glomerular filtration rate measurements.

NCT ID: NCT03377426 Withdrawn - Clinical trials for Complicated Urinary Tract Infections

LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)

Start date: October 19, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections

NCT ID: NCT03370055 Withdrawn - Clinical trials for Wound Healing Delayed

LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study

LiNWEX
Start date: November 2, 2017
Phase: N/A
Study type: Interventional

The trial compare the healing rate of chronic wounds with exposed tendon or bone ('problematic wound area') with LeucoPatch® treatment for 8 up to 16 weeks in addition to usual care versus usual care. The healing rate will be measured as relative reduction of 'problematic wound area' at 8 weeks

NCT ID: NCT03257332 Withdrawn - Quality of Life Clinical Trials

Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.

EDFI-Cohort
Start date: November 12, 2019
Phase:
Study type: Observational [Patient Registry]

Background: Patients treated for rectal cancer are in high risk of developing poor quality of life and faecal incontinence. Faecal incontinence has a negative impact on quality of life. However, there is limited knowledge on how to prevent it. Known exposures are ; age at surgery, gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate the anorectal muscle function for sensory and motor impairment. Exposures representing different constructs in the biopsychosocial model are likewise likely to be associated with quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary incontinence, fatique, physical inactivity and finding meaning in life. There are to our knowledge, no records on these relationships from prior to surgery to 2 years after. These biopsychosocial exposures are central to include when developing strategies that can prevent poor quality of life and faecal incontinence for patients treated for rectal cancer. Purpose: The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual dysfunction, fatigue, physical activity and finding meaning in life) develop over time and predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer from prior to surgery to 2 years after primary treatment. Methods: We will include subjects diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to recruit all eligible patients in a one year period. We estimate to recruit 70 patients. Self-reported outcomes will be collected with a series of validated questionnaires that subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and 104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29) and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding meaning in life (SOME). Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and include: Anorectal manometry that measures anorectal muscle function and rectal perception, a digital examination of anorectal muscle function using the Digital Rectal Examination Scoring System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity. We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple linear regression models for the continuous data. We plan to adjust for known confounders and variables related to treatment.

NCT ID: NCT03245658 Withdrawn - Mortality Clinical Trials

The Effect of Cannabis in Pancreatic Cancer

Start date: October 6, 2017
Phase: Phase 2
Study type: Interventional

Cannabinoids are known to increase appetite, but THC components have psychogenic properties too. CBD is the main component in the plant, and have only minimal psychogenic effects. The aim was to test the appetite stimulating effects of CBD in patients with pancreatic cancer in palliative treatment.

NCT ID: NCT03192969 Withdrawn - Clinical trials for Giant Cell Arteritis

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

Start date: July 15, 2017
Phase: Phase 3
Study type: Interventional

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

NCT ID: NCT02974322 Withdrawn - Crohn Disease Clinical Trials

A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease

Start date: December 1, 2017
Phase: Phase 3
Study type: Interventional

The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease. The study will test GED-0301 compare to placebo for 12 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. Adolescent patients will also be allowed treatment with stable doses of exclusive enteral nutrition and growth hormone. All patients who complete the study will have the option to enter a long term active treatment study.