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NCT ID: NCT02226120 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

Start date: October 16, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

NCT ID: NCT02226016 Not yet recruiting - Ptosis Clinical Trials

Levator Muscle Strength Evaluation

Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess a new technique of measurement for the levator muscle. this measurement may be applied during a clinical evaluation of eyelid malposition. our purpose is to quantify the levator muscle strength and to corelate it to standard levator muscle strength assessment techniques routinley used in the oculoplastic clinic.

NCT ID: NCT02225379 Completed - Type 1 Diabetes Clinical Trials

Development and Assessment of Feasibility of Non-invasive Multiple Sensor Hypo-Sense as a Tool for Detection of Hypoglycemia

Hypo-Sense
Start date: September 2014
Phase: N/A
Study type: Interventional

Hypo Sense is a non- invasive method for detection of hypoglycemia. The Hypo Sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart & respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device. The Hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods The proposed study will be consisting of two main segments: The primary aim of segment 1 of the study is data collection and calibration of the Hypo Sense sensor prototype compared to standard invasive reference glucometer. The primary aim of segment 2 of the study is to validate the Hypo Sense prototype performance in detecting hypoglycemic events. During the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced. The reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will translate the set of the physiological recorded parameters into detection of hypoglycemic events. During the second segment of the study we intend to evaluate the validity of the Hypo Sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).

NCT ID: NCT02224703 Completed - Epilepsy Clinical Trials

GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Start date: April 13, 2015
Phase: Phase 3
Study type: Interventional

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

NCT ID: NCT02223949 Not yet recruiting - Obesity Clinical Trials

Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods

Start date: October 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.

NCT ID: NCT02223572 Not yet recruiting - Osteoporosis Clinical Trials

Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture

Start date: September 2014
Phase: N/A
Study type: Interventional

Due to its prevalence worldwide, osteoporosis is considered a serious public health concern. The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the US only. Hip fracture is associated with serious disability and excess mortality. Studies have shown that an initial osteoporotic fracture is a major risk factor for a new fracture. An increased risk of 14.8% for a secondary hip fracture has been demonstrated in people that have already sustained a fracture in the past 4 years (In average). These data indicate the major opportunity afforded by secondary fracture prevention strategies. By responding to the first fracture, we can reduce the incidence of second and subsequent fractures. However, even after longer medical follow-up according to regular standard of care, medical treatment and rehabilitation, the medical system has been unable to translate the eminent risk into an effective preventive treatment.

NCT ID: NCT02222493 Completed - Clinical trials for Rheumatoid Arthritis

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Start date: August 26, 2014
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

NCT ID: NCT02222311 Not yet recruiting - Autism Clinical Trials

Influence of Vitamin D Deficiency on the Development of Autism

Start date: November 2014
Phase: N/A
Study type: Observational

The investigators wish to study the effect of Vitamin D on the development of autism in children. The investigators will also investigate the environmental and genetic influences on the level of Vitamin D in children with autism.

NCT ID: NCT02222272 Completed - Clinical trials for Myeloid Leukemia, Chronic

Effect of 2nd Gen TKI in CML

Start date: January 1, 2010
Phase:
Study type: Observational

Stem cell transplantation will continue to be a treatment option for patients with chronic myeloid leukaemia, despite the introduction of tyrosine kinase inhibitors. However, many patients will have received prior therapy with TKIs, including Nilotinib or Dasatinib at the time of allogeneic stem cell transplantation. While the use of Imatinib prior to stem cell transplantation seems to have no adverse impact on the outcome of allogeneic stem cell transplantation little is known on the impact of prior use of second generation TK inhibitors. Therefore this non interventional prospective study addresses this question and patients undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will be followed by the data office office on engraftment, treatment related mortality, relapse rate and survival, prospectively. Details on TKI therapy will be collected by the participating centers, retrospectively. This is a non interventional prospective study. There is no upper limit to the number of patients entered, but it is estimated that up to 450 patients will be included in 150 centres for this non interventional prospective study. The registry will include patients for three years plus one more year for follow up and data analysis which should then be followed-up until the projected end of the non interventional prospective study.

NCT ID: NCT02222220 Completed - Clinical trials for Clozapine-induced Hypersalivation

Metoclopramide as Treatment of Clozapine-induced Hypersalivation

Start date: January 2012
Phase: Phase 3
Study type: Interventional

Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable adverse effect of clozapine therapy that can lead to noncompliance. Until now there is no effective enough treatment for this side effect. Previous studies demonstrated that different medications from the substitute benzamide derivatives group: amisulpride, sulpiride (higher selective binding to the D2/D3 dopamine receptor) and moclobemide (reversible inhibitor of monoamine oxidase A, which inhibits the deamination of serotonin, norepinephrine and dopamine) may be effective as a treatment of clozapine-induced hypersalivation (CIH). Moreover, there is another substitute benzamide derivative: metoclopramide (dopamine D2 antagonist, usually used as antiemetic medication in general medicine). The investigators hypothesis assumes that anti-salivation effect characterizes the whole group of benzamide. The aim of this study was to examine the efficacy of metoclopramide as an optional possibility for management of CIH.