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NCT ID: NCT01308554 Completed - Obesity Clinical Trials

Pain Relieving Efficacy of TAP Block in Patients After Laparoscopic Gastric Bypass.

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

The purpose of this study is to determine whether injection of bupivacaine into the TAP is effective in the treatment of post operative pain after laparoscopic gastric bypass

NCT ID: NCT01308385 Completed - Pain Clinical Trials

Prediction and Characterization of Acute and Chronic Postoperative Pain

Start date: April 2011
Phase: N/A
Study type: Observational

Despite enormous progress insufficient postoperative pain management remains a frequent problem in the early postoperative phase after surgery. Furthermore, the pain that persists after healing of the surgical wound is a large, but often unrecognized, clinical problem and it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain leading to chronic disability and psychosocial distress. Conditioned Pain Modulation (CPM), also known as the phenomenon "pain-inhibits-pain", is a reduction in pain somewhere on the body in response to the application of a second painful stimulus outside the painful area. In recent years, the CPM has been identified as a psycho-physical measure with clinical relevance in characterizing the individual's ability to modulate pain and consequently the individual's disposition to acquire painful conditions. The purpose of this study is primarily to assess the relationship between CPM efficacy and clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain) associated with minimally invasive repair of pectus excavatum. In addition, the study aims at identifying other patient- and/or surgery-related factors affecting the course of postoperative pain. Hypothesis: - The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a second painful stimulus (Cold Pressor Test), the lower the risk of developing persistent postoperative pain. Secondary hypotheses - The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) lower the pain intensity in the early postoperative period. - The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the shorter duration of early postoperative pain. - The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test), the lower the usage of epidural analgesia (mg / ml). - The larger the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a different experimental painful stimulus (Cold Pressor Test) the lower consumption of oral analgesics (mg / day). - Severe acute pain in the early postoperative period (postoperative days 0-3) is positively associated with the development of persistent postoperative pain (6 months postoperatively). - Presence of preoperative pain and / or high postoperative use of analgesics and / or high pain intensity during the first 6-8 weeks postoperatively predicts pain 6 months postoperatively. - The higher pain intensity and discomfort associated with brush-evoked allodynia and / or pinprick (Von Frey) secondary hyperalgesia the greater the risk for developing persistent postoperative pain (6 months postoperatively). - High levels of preoperative catastrophizing (assessed on the day of admission) is related to the severity of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively), even if controlled for depression and anxiety. - The degree of preoperative positive and negative emotions (as assessed on the day of admission) is related to the degree of acute pain (rated third postoperative day) and chronic pain (assessed 6 months postoperatively) so that negative emotions are associated with high levels of pain, while positive feelings are related to low levels of pain. - The study population does not differ significantly from the normal population in terms of personality traits (emotional reactions, extraversion, openness to experience, friendliness, conscientiousness). - The study population does not experience a significant change in personality traits during the first 6 months after surgery. - The quality of life and self-esteem is lower among patients who develop persistent postoperative pain compared with pain patients. - Quality of life and self-esteem improve as a result of minimally invasive repair of pectus excavatum.

NCT ID: NCT01307397 Completed - Malignant Melanoma Clinical Trials

A Study of Vemurafenib in Participants With Metastatic Melanoma

Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This multi-center study evaluates the safety and efficacy of vemurafenib in participants with BRAF V600 mutation-positive, surgically incurable, and unresectable Stage IIIC or IV (American Joint Committee on Cancer [AJCC]) metastatic melanoma.

NCT ID: NCT01306747 Completed - Chronic Pain Clinical Trials

Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients

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

The effect of the Stanford Chronic Pain Self-Management Programme (CPSMP) is tested in a randomized controlled trial with enrollment of Danish chronic pain patients. A total of 500 chronic pain patients is randomized into either an CPSMP intervention group or a control group. The CPSMP is brief patient education program consisting of 6 weekly sessions. Two trained instructors teach a group of 8-16 chronic pain patients about managing pain. The instructors are not health professionals but chronic pain patient themselves. The program is highly structured and manualized. Previous studies have shown beneficial effects of the CPSMP on pain, self-efficacy and well-being. Hence we expect the CPSMP to have an effect on various domains. 1. Symptom reduction - lower self-reported pain in the CPSMP group compared to controls 2. Illness perception - the cpsmp group will differ from controls in illness perception and have higher disease related self-efficacy 3. Sickness behavior - the cpsmp group will have fewer sick days and lower health care utilization (estimated by registerbased data)than controls 4. Quality of life - the cpsmp group will report higher life satisfaction and less social isolation than controls

NCT ID: NCT01305837 Completed - Clinical trials for Progressive Multiple Sclerosis

Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis

COMTiMS
Start date: April 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether cyclic oral methylprednisolone once every month has an effect on the intrathecal inflammation in patients suffering from progressive multiple sclerosis.

NCT ID: NCT01305759 Completed - Depression Clinical Trials

Psychological, Sexually and Social Consequences of Osteoarthritis Treatment With THA or TKA and Joint Preserving Surgery

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

The project runs as a Ph.d. project at the Faculty of Health Sciences- University of Copenhagen. In Denmark the investigators operate around 16.000 artificial hips and knees yearly, mainly due to osteoarthritis. The numbers has increased with 13,9% for hips and 50,7% for knees in the period 2004 to 2007. In 10% of the cases, or approximately 1.600 patients, the patient is younger than 50 years - mid-life, working, socially active and sexually active. The investigators have a tendency within in the orthopedic society to mainly focus on the technological aspects of the procedure and tend to forget that this is a key event for the patient with widespread consequences for the patient and his future life. Hip- and knee arthroplasties is without no doubt two of the most important and successfully surgical procedures ever introduced. The economical cost for osteoarthritis treatment has exploded in the developed world over the last decade, with a yearly growth on 8%. Because of the limited lifetime for an artificial hip or knee, this treatment can be unfortunate for the young patient. This has over the last years led to an increased interest for joint preserving surgery. Over the last twenty years it has been tried to delay the time for total hip arthroplasties for patients with hip dysplasia with the aid of Ganz osteotomy. Since this technique was introduced back in 1988, the research on the topic has had its main focus on optimizing the operation technique. So as with surgery with artificial hip or knee the investigators have a lack of knowledge regarding the social, work related, psychological and sexual aspects of this treatment. Purpose The consequences of an artificial hip or knee joint regarding patients' social-life, work, psychological and sexual aspects gain very little attention international. The investigators apply most of our research funds exclusively to research and development of the surgical track and procedure, new prosthesis designs or coatings. The investigators find this study highly relevant because this kind of studies has been preformed for several chronic diseases but not osteoarthritis and its treatment. With this study the investigators wish to examine the social, work related, psychological and sexual aspects of end stage osteoarthritis. This will lead the way for improved information to the patient and improve the surgeons' possibilities for chosen the correct time for surgery.

NCT ID: NCT01305655 Completed - Clinical trials for Acute Lymphoblastic Leukemia (ALL)

Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL

NOPHOCPG2
Start date: July 2008
Phase: Phase 3
Study type: Interventional

Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites to avoid life threatening complications.

NCT ID: NCT01305603 Completed - Pain, Postoperative Clinical Trials

Ultrasound-guided Dual TAP Block: Magnetic Resonance (MR) Evaluation of the Distribution of Local Anesthetic

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

Using Magnetic resonance (MR) scanning and ultrasonography the investigators wish to investigate, in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators compare the anatomical distribution of the local anesthetic injectate in the TAP when performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical TAP block and a Dual TAP block.

NCT ID: NCT01305343 Completed - Clinical trials for Adult Spinal Deformity

Neurologic Complications in Spinal Deformity Surgery

Start date: August 2011
Phase: N/A
Study type: Observational

240 subjects with "high risk" adult spinal deformity requiring surgical correction will be enrolled in a prospective multi-center international study. "High risk" patients are defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurologic complications in the form of new motor and sensory deficits will be monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be adjudicated for relationship to the surgical intervention. Regression analyses will be used to evaluate the association between patient demographics, co morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery.

NCT ID: NCT01304927 Completed - Male Infertility Clinical Trials

Vitamin D Supplementation and Male Infertility: The CBG-study a Randomized Clinical Trial

Start date: February 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Today, it is evident that vitamin D (VD) has more widespread effects than the classical actions related to bone mineralization and calcium homeostasis1. VD deficiency results in impaired reproductive performance in various species of animals, and recently the investigators have shown that the VD receptor (VDR), activating (CYP2R1, CYP27A1, CYP27B1) and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis, seminal vesicle, prostate and spermatozoa. Our following functional studies showed that VD increases intracellular calcium in mature spermatozoa, and hence may be important not only for spermatogenesis but also for sperm maturation. A new, and yet unpublished cross sectional study of 300 young healthy Danish men showed that men with lower levels of serum VD have significantly lower number of normally developed and motile spermatozoa. Hitherto, most cases of male infertility have been classified as "idiopathic", and infertile couples have been referred to symptomatic treatment at infertility clinics. These fertility treatments are often physically demanding for the female partner as well as expensive for the health care system. Any treatment that might improve semen quality of involuntary infertile men would be beneficial both for the infertile couples and the society in general. Our findings that VD may play a role for human semen quality have not yet been tested clinically. However, if VD supplementation proves efficient this opens for the first time for a causal, safe and cheap treatment of at least some cases of "idiopathic" impaired semen quality. The investigators believe our new human data supported by the results from the VD deficient and VDR KO animal studies and the high proportion of VD deficient Danish men provide sufficient evidence to initiate a randomized clinical trial of VD supplementation to infertile men. Infertile men have also have unfavorable altered levels of sex hormones and higher mortality than fertile men. Since VD deficiency is associated with increased mortality, regulation of aromatase, immune system, bone metabolism, glucose metabolism, cardiovascular system etc. our suggested clinical trial may also be able to evaluate several secondary endpoints in addition to the potential effect on semen quality.