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NCT ID: NCT02503748 Completed - Prostate Cancer Clinical Trials

Prostate Cancer E-Health-Tutorial

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

In a participatory process involving urologists and former patients, the project team has developed an online information system ("tutorial") for patients with localized prostate cancer. In this field test, relevant outcomes are measured and the tutorial will be tested for its clinical applicability.

NCT ID: NCT02503644 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis

FASST
Start date: October 29, 2015
Phase: Phase 2
Study type: Interventional

Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin. It is a life-threatening orphan disease with severe physical and psychosocial consequences. IVA337 has a novel mechanism of action and this study is designed to compare IVA337 at two dose levels with a placebo control treatment. Patients will be unaware of the treatment they are receiving and will be randomized to one of three treatment arms , either IVA337 400mg bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and during that time assessments will be made to monitor both the efficacy and safety of the treatment.

NCT ID: NCT02503462 Terminated - Clinical trials for AIDS-related Dementia Complex

Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals

Start date: July 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess whether a boosting by cobicistat results in similar concentrations of darunavir in the brain compared to a boosting by ritonavir.

NCT ID: NCT02502513 Completed - Clinical trials for Posttraumatic Stress Disorder

Prevention of Intrusive Memories and Posttraumatic Stress Symptoms After Emergency Cesarean Section

Start date: June 2013
Phase: N/A
Study type: Interventional

This pilot study aims to investigate the effects of a brief computerized intervention (the computer game "Tetris") on intrusive memories and other posttraumatic stress symptoms following an emergency cesarean section. Patients who have undergone an emergency cesarian section will be randomly allocated to either the brief computerized intervention or usual care within the first 6 hours following the operation. Participants will be followed up at one week and one month. It is predicted that participants given the brief computerized intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple computerized intervention to prevent distressing psychological symptoms after a traumatic event such as an emergency cesarean section.

NCT ID: NCT02501824 Completed - Asthma Clinical Trials

Effectiveness of Anthroposophic Speech Therapy in Patients With Asthma

Start date: October 2010
Phase: Phase 2
Study type: Interventional

Anthroposophic therapeutic speech is a complementary method that indirectly influences breathing and uses specific vowels, consonants, syllables and metres depending on the indication. The aim of this study is to test the effectiveness of anthroposophic therapeutic speech in patients with asthma regarding clinical and physiological parameters, asthma control and quality of life.

NCT ID: NCT02501512 Completed - Immature Newborn Clinical Trials

Maturational Changes in Newborn Infants

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

This study aims to extract and discriminate the signals of respiration, heart rate and swallowing from a standard ECG and EMG signal obtained using a special neonatal gastric tube. These signals will be compared with the standard monitoring signals in the neonatal intensive care unit (NICU). Further, they will be used to search for objectively quantifiable maturational coordination processes of respiration, heart rate and swallowing. Lastly, this study aims to identify changes in ECG/EMG-signals as a result of external stimuli (e.g. nursing interventions) in the NICU.

NCT ID: NCT02501278 Withdrawn - Clinical trials for Uterine Cervical Neoplasms

A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer

Start date: May 2016
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess the potential benefit of the addition of immunotherapy with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and continued as adjuvant in patients with locally advanced cervical cancer. Safety run-in: To test the safety of CRT combined with immunotherapy with INO-3112. This safety run-in phase will include the first 3 patients treated in each of the two INO-3112 combination arms who are exposed to at least two immunotherapy doses and evaluate whether the combination does not pose undue immediate risks to the patients further enrolled in the trial. Phase II:To demonstrate sufficient activity in the experimental combination arms to warrant a further phase III conclusive trial based on progression free survival (PFS) at 18 months assessed by RECIST by the local investigator. The efficacy will be assessed within each experimental arm while the standard arm will serve as a reference arm to check the reliability of the results.

NCT ID: NCT02500992 Recruiting - Clinical trials for Diverticular Disease

Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy

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

Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. The feasibility of the technique has been demonstrated. Still an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis. In this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. The results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.

NCT ID: NCT02500342 Completed - Fatigue Clinical Trials

Effect of Thyroid Hormone Replacement on Fatigability in Untreated Older Adults With Subclinical Hypothyroidism

TRUST FATIGUE
Start date: January 2014
Phase: Phase 4
Study type: Interventional

Thyroid hormone is a key regulatory hormone for a range of physiological systems. An impaired function of the thyroid gland such as subclinical hypothyroidism (SCH) can affect quality of life. Older adults with subclinical hypothyroidism often report non-specific symptoms such as tiredness. In addition, muscle symptoms such as cramps, weakness and myalgia are more common in SCH than in healthy controls. At present, evidence is lacking about the benefits of thyroxine replacement in the elderly with SCH, as no large randomized clinical trials (RCT) on the full range of relevant clinical outcomes, including tiredness have been performed. Moreover, there is continued uncertainty about the long-term impact on health related quality of life of thyroxine treatment for SCH. The aim of the study is to examine, within a large RCT of elderly participants with subclinical hypothyroidism, the impact of thyroxine therapy on the association between subclinical thyroid disease (SCTD) and the level of physical and mental fatigue. The existing trial infrastructure (TRUST thyroid trial-Euresearch FP7; clinicaltrials.gov ID: NCT 01660126) will be utilized to collect information on the level of physical and mental fatigue by using the Pittsburgh Fatigability Scale at baseline and at 1 year from 220 participants with persistent subclinical hypothyroidism randomized to either thyroxine or placebo.

NCT ID: NCT02500173 Terminated - Cancer Clinical Trials

Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy

Start date: June 1, 2015
Phase:
Study type: Observational

To collect and analyze effects and side effects in patients undergoing radiotherapy. This study investigates how analysis of effects and side effects will influence outcome of patients. These retrospectively collected data allow to adapt and improve radiotherapy treatment regimens .