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NCT ID: NCT01966705 Completed - Clinical trials for Somatic Symptom Disorder

Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help

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

Background Severe health anxiety, Somatic symptom disorder or Illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with considerable personal distress, functional disability and societal costs. Several studies have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health anxiety, both on anxiety itself and on secondary symptom measures (for example of depression). One published randomized controlled trial (RCT) has examined the feasibility of delivering CBT for severe health anxiety via the Internet as a form of guided self help. Participants had contact with a therapist via an e-mail-like system throughout the treatment. This approach yielded results superior to a waiting-list condition, thus potentially greatly increasing the availability of psychological treatment. However, more studies on the effects of Internet-delivered CBT are warranted (NCT01673035 being one). Additionally, little is known about the active ingredients and mechanisms of change involved in Internet-delivered CBT. For example, the significance of therapist support in relation to treatment outcomes remains to be determined. CBT-based self-help literature, so called bibliotherapy, has shown great promise in the treatment of several anxiety disorders, including panic disorder and social anxiety disorder. Two small pilot studies have indicated that bibliotherapy with no or minimal therapist contact could be suitable for treating health anxiety. Aim of the study The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33), Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants with severe health anxiety. Participants in all treatment programs are expected to be significantly improved on measures of health anxiety, compared to participants allocated to the waiting-list condition.

NCT ID: NCT01966471 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

Start date: January 31, 2014
Phase: Phase 3
Study type: Interventional

This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

NCT ID: NCT01965652 Completed - Clinical trials for Opioid-induced Constipation

Long Term Safety of Naldemedine

Start date: September 24, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

NCT ID: NCT01965210 Completed - Appetite Regulation Clinical Trials

The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function

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

Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.

NCT ID: NCT01963806 Completed - Panic Disorder Clinical Trials

ACT-smart: Smartphone-supplemented iCBT for Social Phobia and/or Panic Disorder

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

BACKGROUND: Smartphone technology presents a novel and promising opportunity to extend the reach of psychotherapeutic interventions by moving selected parts of the therapy into the real-life situations causing distress. This randomised controlled trial will investigate the effect of a transdiagnostic, Internet-administered cognitive behavioural (iCBT) self-help program for anxiety, supplemented with a tailored smartphone application. The effect of added therapist support will also be studied. METHODS/DESIGN: 150 participants meeting diagnostic criteria for social anxiety disorder and/or panic disorder will be evenly randomised to one of three treatment arms: (1) smartphone-supplemented iCBT with therapist support; (2) smartphone-supplemented iCBT without therapist support; or (3) an active waiting list control group with delayed treatment. After the 10 week treatment period, the control group (3) will receive the same treatment as group (2). Primary outcome measure will be the Generalised Anxiety Disorder 7-item self-rating scale. Secondary measures include other anxiety, depression and quality of life measures. In addition to pre- and post-treatment measurements, the study includes two mid-treatment and two follow-up assessments (12 and 24 months). HYPOTHESES: Based on prior research, we hypothesise that the therapist-guided form will be superior to the unguided form in reducing anxiety levels, and that both delivery modes will be superior to an active waiting-list control group.

NCT ID: NCT01962324 Completed - Prostatic Neoplasms Clinical Trials

Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer

PARAPLY-1
Start date: March 2015
Phase: N/A
Study type: Interventional

A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.

NCT ID: NCT01961921 Completed - Clinical trials for TTR-mediated Amyloidosis

The Study of ALN-TTR02 (Patisiran) for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Patients Who Have Already Been Treated With ALN-TTR02 (Patisiran)

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

NCT ID: NCT01961700 Completed - Lung Cancer Clinical Trials

In-hospital Physiotherapy for Patients Undergoing Thoracic Surgery - a Randomized Controlled Trial

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

Lung cancer is one of the most common types of cancer in the world, and the cancer that causes the most number of deaths. In Sweden, about 3700 persons are diagnosed every year. About one fifth of the patients are eligible for surgery. Patients undergoing thoracic surgery suffer from pain and low health related quality of life after surgery. In Australia, New Zealand, and the United Kingdom, pre- and postoperative physiotherapy is routinely provided for patients undergoing thoracic surgery, but the effects have not been thoroughly investigated. The scientific evidence of the effect of physiotherapy in connection with lung surgery is limited. The treatment typically consists of early mobilisation, breathing exercises and exercises for the shoulders. Reeve et al has shown that a postoperative shoulder exercise program can improve function and decrease pain after thoracotomy. Breathing exercises has not been found effective in reducing the rate of postoperative pulmonary complications after thoracic surgery. The purpose of this study is to investigate the effect of in-hospital physiotherapy treatment, for patients undergoing thoracic surgery, on physical activity, health related quality of life, pain and lung function.

NCT ID: NCT01960907 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trials for Elderly Patients With Multiple Disease

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

The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other typical comorbidities such as congestive heart failure and sleep disordered breathing. A specific ICT platform in combination with a set of innovative devices will be used to collect and process useful clinical data at the patient's home and used to optimize their medical treatment. To evaluate the impact of this solution, an international multi-centric randomized control trial will be implemented in five European regions: United Kingdom, Sweden, Estonia, Spain and Slovenia, representing different social and organizational contexts in Europe.

NCT ID: NCT01960712 Completed - Bile Leakage Clinical Trials

The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.

Start date: November 2008
Phase: N/A
Study type: Interventional

Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.