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NCT ID: NCT02314065 Completed - Clinical trials for Somatic Symptom Disorder

Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy

HA-NonInf
Start date: December 10, 2014
Phase: N/A
Study type: Interventional

Background Severe health anxiety is a highly distressing, often debilitating, psychological problem. Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD) or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several treatments for severe health anxiety have shown great promise, the most well-established being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other psychotherapies - has typically been delivered face-to-face. That is, the patient physically meeting with the therapist once a week for the whole of the treatment. Internet-delivered CBT does not rest on this requirement, but has nevertheless been shown to be efficacious for severe health anxiety (see for example NCT01673035). Aim of the study The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is applied to determine if Internet-delivered CBT is at least as efficacious as its well-established predecessor.

NCT ID: NCT02313220 Completed - Obesity Clinical Trials

Exploratory Study to Investigate the Effect of Dapagliflozin and Exenatide Combined on Body Weight

Dapalost
Start date: December 2014
Phase: Phase 2
Study type: Interventional

Obesity is a medical condition which increases the risk of other diseases, such as type 2 diabetes and cardiovascular disease. Obesity-related risk factors for the development of other metabolic diseases include unstable glucose levels and high blood pressure. Dapagliflozin and exenatide are both approved worldwide for treatment of patients with Type 2 Diabetes. Dapagliflozin works by lowering glucose levels by inhibiting the renal reabsorption of glucose and thereby promoting its urinary excretion and energy loss and thereby reduction in body fat. Exenatide exhibits many of the same glucose-lowering actions of that of a naturally occurring hormone and leads to weight loss mainly via reduced energy intake, most likely via a central effect on appetite regulation. The purpose of this exploratory study is to investigate if a combination treatment with dapagliflozin and exenatide have a synergistic effect on weight loss in non-diabetic obese subjects. Subjects will be treated for 24 weeks with either active combination treatment or placebo (non-active treatment). Neither study personnel nor subjects will know what treatment is given. All subjects completing the 24-week double-blind study and who are willing and eligible will be offered to enter a 28-week open-label extension study. All subjects entering the extension study will receive unblinded active study treatment for an additional 28 weeks. Thus the total treatment period for subjects entering the extension study will be 52 weeks.

NCT ID: NCT02312960 Completed - Clinical trials for Neoplasm Metastasis / Bone and Bones

Radium-223 Dichloride Long-term Follow-up Program

Start date: December 18, 2014
Phase: Phase 4
Study type: Interventional

Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .

NCT ID: NCT02312258 Completed - Multiple Myeloma Clinical Trials

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)

Start date: April 9, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.

NCT ID: NCT02311231 Completed - Clinical trials for ST-segment Elevation Myocardial Infarction

Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART

VALIDATE
Start date: June 2014
Phase: Phase 4
Study type: Interventional

In this trial we test the hypothesis that PCI and bivalirudin is superior to heparin alone (according to local protocol) in reducing death, MI, and major bleeding in patients with NSTEMI or STEMI at 180 days (primary end point), treated with ticagrelor or prasugrel.

NCT ID: NCT02307331 Completed - Osteoarthritis Clinical Trials

RSA Study of Sirius Stem and Exceed Cup

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

The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom polyethylene, and OptiPac/OptiVac bone cement mixing systems.

NCT ID: NCT02306941 Completed - Abdominal Pain Clinical Trials

Internet-delivered CBT for Functional Abdominal Pain in Adolescents - a Pilot

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

This pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program adjusted for adolescents with functional abdominal pain and functional dyspepsia.

NCT ID: NCT02306434 Completed - Pregnancy Clinical Trials

Fear of Childbirth - Comparison of Two Treatments

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

Childbirth related fear is a public health issue strongly related to subsequent reproduction, a request for caesarean section and women's and children's health. Currently, women are offered 3-5 counseling sessions with specially trained midwives and obstetricians in most Swedish hospitals as standard care (SC). In general, women are satisfied with counseling but research show no major effect on cesarean section rates neither in decreased level of childbirth related fear. It is therefore important to find the best available treatment for this issue. The aim of this program is to compare Internet given cognitive behavior therapy (ICBT) with standard counseling care for pregnant women reporting childbirth related fear. Research questions: What effect does ICBT compared to SC have on a) the level of childbirth related fear b) a request for cesarean section c) compliance and satisfaction with treatment. Design: A randomized controlled trial of women reporting childbirth related fear during pregnancy. One arm will receive SC and one arm ICBT though the U-CARE platform. Follow up of given treatment will occur at 30 and 36 weeks of pregnancy, two months and one year after birth. Intervention: The intervention will focus on management of childbirth related fear. This means that the participants do weekly sessions and homework assignments during pregnancy. Primary outcome will be level of childbirth related fear measured at 36 weeks of pregnancy. Secondary outcomes are level of childbirth related fear at 2 months and one year after birth, preferences for mode of birth, request for elective cesarean section, compliance and satisfaction with treatment and costs. Expected benefits: This study will contribute to the development of new treatment methods for childbirth related fear. Evidence of the best treatment to reduce childbirth related fear based on the results from this study could be implemented in clinical practice and hopefully decreases the numbers of cesarean sections without medical indications.

NCT ID: NCT02306369 Completed - Clinical trials for Irritable Bowel Syndrome

Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents

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

This randomized controlled trial aims to evaluate the treatment effects of an internet-delivered CBT-program for adolescents with irritable bowel syndrome.

NCT ID: NCT02306356 Completed - Clinical trials for Generalized Anxiety Disorder

Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting

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

An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.