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NCT ID: NCT01691209 Withdrawn - Dermatitis, Atopic Clinical Trials

Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis

Phoenix
Start date: October 2013
Phase: N/A
Study type: Interventional

The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).

NCT ID: NCT01686737 Withdrawn - Breast Neoplasms Clinical Trials

Iyengar Yoga for Chemotherapy-induced Fatigue in Breast Cancer Patients

IFaB
Start date: November 2012
Phase: N/A
Study type: Interventional

Breast cancer is the most frequent cancer in women and is associated with profound restrictions of health-related quality of life and psychosocial health. More than three-quarters of women with breast cancer suffer from fatigue during cancer treatment. While exercise interventions can improve fatigue in breast cancer patients, many patients request complementary treatment approaches. Therefore, this study investigates the effects of yoga in women with breast cancer compared to aerobic exercise and usual care. It is hypothesized that yoga is more effective than usual care and equally effective as aerobic exercise.

NCT ID: NCT01680757 Withdrawn - Atrial Fibrillation Clinical Trials

Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III

PLACE III
Start date: September 2012
Phase: Phase 4
Study type: Interventional

This study is a prospective, multicenter, non‐randomized trial of a stand‐alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post‐treatment.

NCT ID: NCT01622413 Withdrawn - Clinical trials for Lumbar Disc Herniation

Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy

TESCORT
Start date: September 2013
Phase: N/A
Study type: Interventional

This study compares an endoscopic transforaminal surgical technique for the treatment of a herniated disc to the standard microsurgical procedure. Clinical parameters as well as health economy will be assessed. The study hypothesis is that the endoscopic approach is equivalent or superior to microdiscectomy.

NCT ID: NCT01579396 Withdrawn - Acute Kidney Injury Clinical Trials

High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery

HICOSIRS
Start date: April 2012
Phase: N/A
Study type: Interventional

A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase the postoperative IL-6/Il-10 ratio.

NCT ID: NCT01556152 Withdrawn - Clinical trials for Painful Diabetic Neuropathy

A Clinical Trial to Study the Effects of GRC 17536 in Patients With Painful Diabetic Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients)

Start date: n/a
Phase: Phase 2
Study type: Interventional

Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioids, and anti epileptic drugs. However, only two drugs (duloxetine and pregabalin) have been formally approved by the EMEA and the US FDA for the treatment of painful DPN. Generally, the available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. This is randomized, double-blind, placebo-controlled, parallel group study. The study will include patients with type 1 or type 2 diabetes mellitus with history of pain attributed to DPN for least 6 months and no greater than 5 years. Patients will be recruited after providing written informed consent.

NCT ID: NCT01546012 Withdrawn - Clinical trials for Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops

Assessment of Patient's Satisfaction Regarding the Handiness of Two Hyaluronic Acid Eye Drops Vials

Start date: n/a
Phase: N/A
Study type: Interventional

Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.

NCT ID: NCT01536327 Withdrawn - Muscle Weakness Clinical Trials

Biomarker for Metachromatic Leukodystrophy (BioMeta) Disease

BioMeta
Start date: August 20, 2018
Phase:
Study type: Observational

Development of a new MS-based biomarker for the early and sensitive diagnosis of Metachromatic Leu-kodystrophy disease from blood (plasma)

NCT ID: NCT01528670 Withdrawn - Particle Therapy Clinical Trials

Monitoring of Patients Treated With Particle Therapy Using Positron-Emission-Tomography (PET): The MIRANDA Study

MIRANDA
Start date: May 2019
Phase:
Study type: Observational

The purpose of this clinical study is to investigate the clinical feasibility and effectiveness of off-line Positron-Emission-Tomography (PET) quality assurance for promoting the accuracy of proton and carbon ion beam therapy. One main clinical advantage of ion therapy over conventional radiation therapy is the excellent conformation of the delivered dose to the tumour volume while well sparing the surrounding healthy tissue. However, clinical exploitation of this potential to the maximum extent requires in-vivo validation of the actual treatment delivery and, in particular, of the ion beam range within the patient. Since the primary ions are completely stopped in the target volume as opposed to photon radiation, no conventional quality assurance techniques like transmission electronic portal imaging can be applied to monitor ion beam therapy. Hence, ion treatment planning currently relies on models and experimental data accurately validated in tissue-equivalent targets, but no direct verification of the actual treatment delivery and of the ion beam range within the patient is possible in standard clinical practice. At present, PET offers the unique possibility to monitor the precision of ion irradiation in-vivo and non-invasively. The method is based on the detection of the b+-activity which is formed as a by-product of the irradiation, i.e. without administration of radio-tracers to the patient. A positive clinical impact of in-beam (i.e. during the irradiation) PET monitoring has been demonstrated for carbon ion therapy in the pilot project at GSI Darmstadt, Germany, and promising clinical data of post-radiation PET/CT imaging have been recently reported for passive proton beam delivery in USA and Japan. Therefore, a pilot clinical study is hereby proposed at the Heidelberg Ion Therapy Center in order to 1) assess the applicability of post-radiation PET imaging to scanned ion beam delivery, 2) identify the patient population which may benefit from it and 3) extract population-based information on the reliability of the beam range in different tumour locations for all the ion species clinically available at HIT. The investigated patients are expected to benefit from this study, since in case of detected deviations between planned and actual treatment delivery a proper correction could be applied in the next irradiation fraction, assuring an overall better treatment than without any monitoring. Moreover, site-specific patient-population information on the ion range precision at HIT might enable improvement of the CT-range calibration curve as well as safe reduction of the treatment margins to promote enhanced treatment plan conformality for full clinical exploitation of the promises of ion beam therapy.

NCT ID: NCT01524120 Withdrawn - Ulcerative Colitis Clinical Trials

Endoscopy and Endomicroscopy for Assessment of Mucosal Healing in Inflammatory Bowel Disease (IBD)

Start date: April 2012
Phase:
Study type: Observational

Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure. The main objective of this study is to determine endoscopic and endomicroscopic features of mucosal healing in patients with IBD.