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NCT ID: NCT02616562 Recruiting - Clinical trials for Growth Hormone Disorder

Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Start date: March 23, 2016
Phase: Phase 2
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 (somapacitan) treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency. The trial consists of a 26 week main trial period, followed by a 26 week extension trial period, a 104 week safety extension period, a 208 week longterm safety extension trial period and a 30 day follow up period. Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods. Two additional age groups, cohort II (age below 2 years and 26 weeks at screening) and cohort III (above 9 years (girls)/ above 10 years (boys) and equal to or below 17 years at screening) are included in the 208 week long-term safety extension trial period only.

NCT ID: NCT02616068 Completed - Pain Clinical Trials

Comparative Study of Loxoprofen Sodium Transdermal Patch and Loxonin® Tablets for the Treatment of Acute Trauma

Start date: October 2015
Phase: Phase 3
Study type: Interventional

This study evaluates the non-inferiority of the new transdermal patch dosage form containing loxoprofen sodium (100 mg - Daiichi-Sankyo) in comparison with oral Loxonin® (60 mg tablet - Daiichi-Sankyo) for the treatment of acute traumatic injuries.

NCT ID: NCT02615262 Completed - Cardiac Surgery Clinical Trials

Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Start date: December 2015
Phase: Phase 3
Study type: Interventional

Perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.

NCT ID: NCT02613832 Completed - Stroke Clinical Trials

Applicability of Techniques of Lung Expansion

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

The survival of patients with lesions in the central nervous system is usually accompanied by physical and mental sequelae. These impairments favor the prolonged restriction to the bed, which may contribute with changes in respiratory function. In this context, lung re-expansion techniques are used to prevent or treat the various respiratory complications.

NCT ID: NCT02613702 Active, not recruiting - Gingival Recession Clinical Trials

Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial

EFFECT
Start date: December 2015
Phase: N/A
Study type: Interventional

This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.

NCT ID: NCT02613546 Recruiting - Sexual Dysfunctions Clinical Trials

THE INFLUENCE OF COGNITIVE BEHAVIORAL THERAPY IN SEXUAL DYSFUNCTION FEMALE: Randomized Clinical Trial

Start date: September 10, 2015
Phase: N/A
Study type: Interventional

This research is a randomized clinical trial aims to evaluate the influence of cognitive-behavioral psychotherapy (CBT) on quality of life and sexual function of patients with sexual dysfunction. The notion of sexual health for the World Health Organization exceeds the concept of sickness absence, having a subjective well-being of significance in the spheres of self-concept, self-image, interpersonal relationships and sense of self worth. Furthermore, sexual satisfaction and relationship quality of life is also evidenced in many studies. CBT is a brief and focal psychotherapy with proven efficacy in several mental disorders, improving health and quality of life of the treated populations. However, they did not find clinical trials that showed the effectiveness of CBT in Sexual Dysfunctions. This study aims to then fill this gap by evaluating the relationship from the use of techniques of CBT.

NCT ID: NCT02611830 Completed - Colitis, Ulcerative Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Start date: December 18, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02611817 Completed - Crohn's Disease Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)

Start date: January 4, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02611414 Recruiting - Dyspepsia Clinical Trials

Effectiveness of tDCS for the Treatment of Functional Dyspepsia

Start date: January 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Functional dyspepsia is a very common disorder of great challenge to clinical management. A therapeutic targets is up-regulation of visceral pain threshold. The transcranial direct current stimulation (tDCS) is a novel therapy that pursues these properties, besides its safety and easy adherence. There is a great need of new treatments for functional dyspepsia. There is no current study evaluating tDCS for this disease.

NCT ID: NCT02610842 Completed - Scleroderma Clinical Trials

Hands on - a Hand Care Guide in Systemic Sclerosis

Start date: January 2015
Phase: N/A
Study type: Interventional

Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to apply a home based hand care guide in patients with SS and to evaluate its response regarding hand pain, function, strength and mobility.