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NCT ID: NCT03589222 Not yet recruiting - Clinical trials for Refractory Multiple Myeloma

SELIBORDARA: Selinexor, Bortezomib and Daratumumab in Multiple Myeloma

Start date: July 15, 2018
Phase: Phase 2
Study type: Interventional

Phase 2, single-arm, open, non-randomized, multicenter study of the SINE™ compound selinexor plus low-dose dexamethasone, in combination with bortezomib and daratumumab. 100 mg selinexor (on days 1, 8, 15 and 22), plus 40 mg dexamethasone (20 mg IV the day of daratumumab and selinexor and 20 mg oral administration the day after daratumumab and selinexor) both weekly as continuous therapy. Bortezomib will be given via subcutaneous at dose of 1.3 mg/m2 once weekly on days 1, 8, 15 and 22 during the cycles 1 to cycle 8, and on day 1 and day 15 of each cycle thereafter as continuous therapy. Daratumumab will be given via intravenous at dose of 16 mg/Kg on days 1, 8, 15 and 22 (weekly) during the cycles 1 and 2, every two weeks (on days 1 and 15) during the cycles 3 to 6 and on day 1 of each cycle thereafter as continuous therapy. Patients may continue indefinitely and there is no maximum treatment duration

NCT ID: NCT03588702 Recruiting - Lipolysis Clinical Trials

RF and PEMF Following Liposuction

Start date: July 2, 2018
Phase: N/A
Study type: Interventional

The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by reducing fat cell size and enhancing collagen synthesis as the result of thermal and non-thermal collagen stimulation. This is an open-label, evaluator-blind study of the safety and performance of radiofrequency (RF) and pulsed electromagnetic field (PEMF) therapy following liposuction. The study will enroll up to 50 male and female subjects requesting treatment of the back, flanks and/or thighs to improve appearance following liposuction. Subjects will receive a total of six study treatments to one side of their body (back, flanks and/or thighs) at one week intervals. Subjects will be followed up at one month after their last study treatment. Treatment outcomes will be compared to the non-treated side.

NCT ID: NCT03588325 Not yet recruiting - Sepsis Clinical Trials

Evaluation of MDW for Early Detection of Sepsis, Clinical Validity

Start date: July 2018
Study type: Observational

The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of ED adults who have blood draw including CBC-DIFF ordered upon presentation in a Spanish & French hospital and to verify cut-off for K3EDTA.

NCT ID: NCT03588299 Not yet recruiting - Hemophilia A Clinical Trials

Factor VIII Gene Therapy Study in Patients With Hemophilia A

Start date: July 16, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of the factor VIII gene transfer treatment with BAY 2599023 (DTX201) in individuals with severe hemophilia A.

NCT ID: NCT03588104 Not yet recruiting - Diabetes Mellitus Clinical Trials

"POWER2DM Evaluation Campaign"

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

Rationale: Hyperglycaemia is an important cause of long-term macro-and microvascular complications in all patients with diabetes mellitus. However, only a small fraction of the patients with diabetes reaches the set target of glycemic control. Problems with adequate self-management usually underlie problems to maintain glycaemic control. Thus, patients need more support in order to reduce the burden and increase the effectiveness of their diabetes self-management. One way to do this is by using integrated technologies and personalized plans for diabetes care. For this purpose, the POWER2DM support system was developed to give patients insight into their condition and support diabetes patients and their health care professionals in setting and achieving self-management goals using predictive computer model simulations and behavioural action plans. Objective: To provide proof of concept that POWER2DM is safe and effective in improving glycaemic control, improving behavioural/psychosocial and lifestyle markers, and to assess the cost-effectiveness of the approach and to highlight any potential issues that may impede implementation. Study design: This is a pragmatic randomised controlled trial with 9 months follow-up in which patients will be randomised 1:1 to either Power2DM support (Power2DM group) or usual care (usual care group). There will be evaluation moments at baseline, after 11 weeks, 22 weeks and 37 weeks. Study population: 230 patients with diabetes (N=115 T2DM, N=115 T1DM) recruited from out-patient clinics in the Netherlands (Leiden University Medical Centre and affiliating teaching hospitals N=115) and Córdoba, Spain (Reina Sofia University Hospital N=115). Intervention: The POWER2DM support group will receive access to the prototype 2 of the POWER2DM system. This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry. Main study parameters/endpoints: Change in glucose regulation as measured by %HbA1c before and after the intervention compared between the intervention and control group.

NCT ID: NCT03587766 Recruiting - Clinical trials for Chagas' Disease (Chronic) Nos

Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease

Start date: November 13, 2017
Phase: Phase 2
Study type: Interventional

This study focuses on the evaluation of low doses (600 and 1200 mg) and short treatment duration (at 3, 7 and 10 days) of fexinidazole (Fexi) to determine the minimal efficacious and safe dose for the treatment of adult patients with chronic indeterminate Chagas Disease (CD).

NCT ID: NCT03587376 Recruiting - Alzheimer Disease Clinical Trials

Characterization of T-Cell Response in Participants Previously Treated With JNJ-54861911 (Atabecestat)

Start date: May 30, 2018
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine T-cell mediated inflammatory immune response in some participants previously exposed to atabecestat.

NCT ID: NCT03584581 Recruiting - Metabolic Syndrome Clinical Trials

Effects on Lipid Metabolism of Olive Extracts Rich in Polyphenols

Start date: June 1, 2018
Phase: Phase 2
Study type: Interventional

This study is designed to determine whether a standardized intervention in the health center and based on hygienic dietary measures and physical exercise, supplemented with a polyphenol extract in patients, achieves a greater benefit in the reduction of LDL cholesterol in dyslipidemias in the short term.

NCT ID: NCT03583242 Recruiting - Clinical trials for Diabetic Macular Edema

Multimodal Image Study of Retinal Inflammation Markers After Corticoid and Antiangiogenic Treatment in Pacients With Diabetic Macular Edema

Start date: May 23, 2018
Study type: Observational

- Main objective: Inflammation factors in imaging techniques of diabetic macular edema - Prospective observational design - Disease under study: Diabetic macular edema - Methodology: Collection of the image data in the usual control (baseline visit, 4th month) - Population under study and total number of subjects Diabetics with macular edema. - Approximate N: 80 pacients. - Expected duration of the study: 12 months.

NCT ID: NCT03583203 Recruiting - COPD Clinical Trials

Tobacco Intensive Motivational and Estimate Risk

Start date: July 12, 2018
Phase: N/A
Study type: Interventional

Randomized, open label, prospective study with a 12-month follow-up period. The primary objective evaluates the effectiveness of an intensive anti-smoking programme that informs patients of their individual risk of lung damages and the possibilities of prevention. The main measurement will be having given up smoking in month 12, measurement of self-reported abstinence on the 7 previous days and confirmed by a CO-oximeter test< 10 ppm, between the intervention and control group. A total of 9 urban and rural mental health centres will participate in the study. The intervention group will undergo spirometry and presence and the degree of respiratory obstruction will be assessed. Participants will be given individual information to generate a motivational message about the possibilities of prevention and the information will be maintained for three months by sending text messages (SMS) to their mobile phones. The efficacy of the method and the pulmonary damage variables will be evaluated: smoking cessation at the end of follow-up will be confirmed by cooximetry, and the COPD diagnosis and the severity of the staging for disease will be assessed