Clinical Trials Logo

Filter by:
NCT ID: NCT01297465 Completed - Clinical trials for Assisted Reproductive Techniques

PERgoveriS In Stratified Treatment for Assisted Reproductive Technique

PERSIST
Start date: May 31, 2011
Phase: Phase 3
Study type: Interventional

This is a multicenter, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle. Down-regulation treatment will start within 2 months following the screening visit. The routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be performed just before randomization and start of recombinant human follicle-stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial: - GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5 followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. - Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular development will be monitored according to the center's standard practice by ultrasound (US) and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm). After this, a single injection of r-hCG will be administered in order to induce final oocyte maturation. At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET) and luteal support will be performed as per center's standard practice. A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding pregnancy testing).

NCT ID: NCT01297075 Completed - Chronic Disease Clinical Trials

Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial

Output
Start date: March 2011
Phase: N/A
Study type: Interventional

The aim of this project is to motivate and support general practice clinics in implementing the visions and recommendations presented in two of the disease specific programmes for chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These programmes describe evidence based treatment and division of tasks between the municipalities, the hospitals and general practice. The Facilitator Project is funded by The Danish Ministry of Interior and Health.

NCT ID: NCT01296334 Completed - Pain Clinical Trials

Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine

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

Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury. The objectives are: - to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine). - to investigate if these effects are related to the volunteers individual pain sensitivity

NCT ID: NCT01295294 Completed - Uterine Hemorrhage Clinical Trials

Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)

Start date: March 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena. The study drugs tested are tested against placebo ("dummy medication not containing any active drug"). Treatment period is followed by a one-month period when study drugs are not taken but Mirena use is continued.

NCT ID: NCT01295203 Completed - Physical Activity Clinical Trials

Internet-based Physical Activity Intervention

Start date: May 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether access to a website with personalized feedback on physical activity level and suggestions to increase physical activity results in improvements in self-reported physical activity, anthropometrics and physiological measurements

NCT ID: NCT01295086 Completed - Adenocarcinoma Clinical Trials

Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer

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

The primary aim of this dose-finding study is to determine the maximum tolerated dose of taxotere, eloxatin and capecitabine (TEX) in combination with herceptin given every third week as first-line treatment in patients with HER2-positive advanced gastro-esophageal cancer. Secondary end points are to evaluate progression-free survival and overall survival.

NCT ID: NCT01293253 Completed - Clinical trials for Cardiovascular Health

Effect of Daily Stair Walking on Cardiovascular Health

IRMA
Start date: March 2011
Phase: N/A
Study type: Interventional

Many adults find it difficult to perform physical exercise during leisure. The workplace may provide an optimal setting to encourage a healthier lifestyle. This study investigates the effect of daily stair walking at the workplace on cardiovascular health. The main hypothesis is that daily stair walking for 10 weeks compared with a control group results in increased aerobic fitness.

NCT ID: NCT01292551 Completed - Clinical trials for Hypoplastic Left Heart Syndrome

Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.

TEMPO
Start date: February 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle physiology) and who have undergone TCPC as a palliative surgical treatment. The aim of the TCPC operation is to use the one functioning ventricle to pump the blood flow to the body, while the blood to the lungs is received directly from the caval veins, and is thus a passive flow, without the aid of a ventricle to actively pump the blood through the pulmonary circulation. The resistance in the pulmonary circulation is therefore critical to these patients. These patients have markedly lower work capacity in bicycle test than the general public. Furthermore they have a high risk of developing complications e.g. loss of protein from the intestines. Bosentan is a medication that lowers the resistance in the pulmonary circulation. It is routinely used for patients with pulmonary hypertension. Some studies have shown that drugs that lower the pulmonary resistance can increase exercise capacity significantly in patients with single ventricle physiology. In this study 80 patients will receive either placebo or Bosentan for 14 weeks. Before and after the treatment, bicycle test along with blood samples, stool samples and quality of life interviews will be performed. Every four weeks during the study blood samples, physical exam and interviews will be performed to ensure the safety of the treatment. The investigators expect to find a significant increase in work capacity after 14 weeks in the treatment group compared with the placebo group. Moreover the investigators hope to find a decrease in intestinal protein loss and an improved quality of life.

NCT ID: NCT01292512 Completed - Grief Clinical Trials

Bereavement Management - Description, Assessment and Care

Start date: June 2009
Phase: N/A
Study type: Interventional

This study aims to develop a risk assessment tool to identify bereaved in risk of complicated grief reactions and to implement a bereavement management programme in primary health care based on the Dual Process Model of coping with bereavement. Furthermore to enhance bereavement care in general practice and to enhance patients' self-management in bereavement care.

NCT ID: NCT01292473 Completed - Clinical trials for Chronic Idiopathic Urticaria

A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.