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NCT ID: NCT01283607 Completed - Depression Clinical Trials

E-health Cognitive Behavioral Therapy in Women Treated by in Vitro Fertilization (IVF)

Start date: February 2011
Phase: N/A
Study type: Interventional

Yearly, 15,000 Dutch in vitro fertilization (IVF) cycles are performed for subfertility with a pregnancy rate of 26%. A failed cycle has great emotional impact; 20-25% of the women has relevant forms of depression/anxiety even after 6 months. For such maladjustment a risk profile has been identified and translated into a screening tool. Identification of women at risk enables a timely and tailored (individual's needs) cognitive behavioral therapy (CBT), which reduces more serious maladjustment and corresponding costs. Aim: To investigate the effectiveness of an e-health CBT (digital coaching, Digicoach) in women ongoing IVF and having been screened at risk. Design: A single-centered randomised controlled trial comparing Digicoach (intervention) with standard care (control). Digicoach: an e-health CBT with 4-12 weekly sessions starting before an IVF cycle, following a woman's IVF course and covering in modules the main problems: depressed mood, anxiety, strong focus on child wish and acceptance. Main outcome measures: anxiety and depression occurrence rate 3 weeks after an unsuccessful IVF cycle. Secondary outcome measures: 1. (para)medical consumption, 2. quality of life, 3. productivity loss and 4. IVF outcome. Data are collected by questionnaires, diaries, medical record audit and page view registrations. Process evaluation: Individual's use (e.g. module progress, completion rate), experiences, (e.g. satisfaction and usability) and potential barriers for implementation are evaluated. Economic evaluation: studied during the Digicoach exposures from a societal perspective. Incremental costs (costs/%avoidance of depression/anxiety) are determined by comparing both study groups. Power/data analysis: To detect a 29% difference in the depression/anxiety occurrence rates (alfa=0.05 and beta=0.80) 58 unpregnant IVF women are evaluated.

NCT ID: NCT01283516 Completed - Clinical trials for Tumors Characterized by Genetic Abnormalities of ALK

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase

Start date: January 24, 2011
Phase: Phase 1
Study type: Interventional

This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).

NCT ID: NCT01283438 Active, not recruiting - Clinical trials for Lumbar Disc Herniation

A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

Start date: December 17, 2010
Phase: Phase 4
Study type: Interventional

A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.

NCT ID: NCT01283139 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

Start date: March 31, 2011
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).

NCT ID: NCT01282450 Completed - Clinical trials for Non-small Cell Lung Cancer

Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone for Patients With Oligo-metastatic Stage IV Non-small Cell Lung Cancer (NSCLC)

Start date: May 2006
Phase: Phase 2
Study type: Interventional

In recent years, it has become clear, that also in non-small cell lung cancer (NSCLC), a group of patients with less than 5 distant metastases may experience long-term survival when treated radically to all macroscopic cancer sites. Thus has mostly been established for individuals with so-called solitary brain metastases and to a lesser extend in solitary adrenal gland metastases, but in other metastatic subgroups, the same may be applicable. In a prospective survey in the region of the Integral Cancercentre (IKL), we could identify on a yearly base 30 patients with NSCLC who could theoretically be amendable for radical treatment of all oligo-metastatic locations. We therefore want to perform a prospective study in which patients with less than 4 oligo-metastatic sites from a primary NSCLC will be treated radically with the aim to improve long-term survival. As many discussion points remain, even after thorough discussions with chest physicians, pulmonary surgeons and colleagues from diagnostic disciplines, we decided to go for a pragmatic approach, implying that all macroscopic disease sites should be treated radically, being defined as surgery with a R0 resection or in case of an unforeseen R1 resection, followed by radiotherapy, or radiotherapy to a biological equivalent of at least 60 Gy in 30 daily fractions. In the same patient, one metastatic site may be treated with surgery and another with radical radiotherapy. Systemic treatment was not made mandatory, because it was felt that it's role is unclear in patients with early stage local cancer and with oligo-metastatic disease.

NCT ID: NCT01282437 Completed - Clinical trials for Non Small Cell Lung Cancer (NSCLC)

Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC

NVALT11
Start date: January 2009
Phase: Phase 3
Study type: Interventional

For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.

NCT ID: NCT01281735 Recruiting - Clinical trials for Chronic Myeloid Leukemia

International Chronic Myeloid Leukemia Pediatric Study

ICMLPed
Start date: January 2011
Phase:
Study type: Observational

The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.

NCT ID: NCT01281527 Completed - Schizophrenia Clinical Trials

Paliperidone Palmitate Flexible Dosing in Schizophrenia

PALMFlexS
Start date: November 2010
Phase: Phase 3
Study type: Interventional

This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.

NCT ID: NCT01281280 Completed - Epilepsy Clinical Trials

PuLsE 2-Observational Long-Term Effectiveness Follow-Up Study of PuLsE 1

PuLsE 2
Start date: March 2011
Phase: N/A
Study type: Observational

This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

NCT ID: NCT01281241 Active, not recruiting - Heart Failure Clinical Trials

Study on Mechanical and Electrical Alternans

Start date: September 2010
Phase: N/A
Study type: Observational

The main objective is to investigate mechanical alternans and MTWA in patients with heart failure caused by coronary artery disease to demonstrate a possible correlation between these two phenomena.