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NCT ID: NCT01191164 Not yet recruiting - Breast Cancer Clinical Trials

Pilot Study of Partial Breast Irradiation Utilizing Permanent Breast Seed Implant to Treat Breast Cancer

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

Background: Recent single arm studies have suggested that partial breast irradiation (PBI), delivered in a relatively short overall treatment time of a few days, may be an effective alternative to adjuvant whole breast irradiation (WBI) delivered over a number of weeks. Several PBI modalities and techniques have been investigated, including interstitial brachytherapy and external beam radiation therapy, most often given over the course of one week of twice daily outpatient treatments. One randomized study has shown equivalency between WBI and PBI using brachytherapy. There are currently three large phase-III randomized studies comparing PBI to WBI. Permanent Breast Seed Implant (PBSI) is the newest PBI technique which has been piloted at the Odette Cancer Centre (OCC) in Toronto. The main advantage of this technique is that it requires only one out-patient procedure. The treatment is administered by implanting radioactive Palladium (103Pd) seeds into the tumor bed region in a 1 to ½ hour outpatient procedure, after which the patient is discharged home to resume her normal living activities. This PBI procedure was shown to be well tolerated with minimal acute toxicity. Estimated partner radiation exposure was well within internationally acceptable levels. Subjects with a seroma >2cm were, however, excluded. Hypothesis: PBSI is a feasible, safe, and acceptable treatment option for the subject and her partner in the context of medical practice and resources in BC. Objectives: In subjects who have undergone breast conserving surgery for early breast cancer: 1. To determine the technical feasibility of PBSI in BC 2. To measure the subject's partner in terms of radiation protection 3. To evaluate acceptability of PBSI by the subject 4. To assess resource requirements for PBSI Method: This is a single arm feasibility study. Five women who had undergone breast conserving surgery for breast cancer with low risk of local recurrence will be accrued. This study will adhere to a detailed written protocol for radiation measurements and protection. Subjects will undergo PBSI within 4-14 weeks from last breast surgery. The procedure will be performed in an outpatient setting, under conscious sedation and local anesthesia, by a team with a wide brachytherapy experience. The technique used in this feasibility study will be based on the OCC technique. It is intended that two oncologists and one physicist will spend 2-3 days at the OCC to acquire detailed and firsthand knowledge of the technique as implemented at that centre. The OCC technique is US-based; in this study, however, an additional CT-assisted planning component will be investigated building on the experience of the VIC team which conducted the BC Cancer Agency Vancouver Island Centre's pilot study of CT-based multi-catheter brachytherapy PBI. Systemic therapy will be according to BCCA guidelines; however, subjects requiring adjuvant chemotherapy will be excluded from this study. Subjects will be followed prospectively for 5 years for evaluation of toxicity, QOL and cosmesis. Disease status will be recorded. Relevance: Completing adjuvant breast irradiation with a single out-patient treatment could significantly improve QOL and convenience for patients choosing breast conserving therapy. Confirming the technical feasibility and safety of PBSI is needed before progressing to larger prospective evaluation of this novel adjuvant radiation therapy technique as a viable treatment option for women in British Columbia.

NCT ID: NCT01157052 Not yet recruiting - Colorectal Cancer Clinical Trials

Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The investigators hypothesize that Ca2+/MG2+ infusions will not have a significant effect on oxaliplatin pharmacokinetics.

NCT ID: NCT01126307 Not yet recruiting - Epilepsy Clinical Trials

Study of Verapamil in Refractory Epilepsy

Start date: June 2010
Phase: N/A
Study type: Interventional

Epilepsy is one of the most common chronic neurological diseases, affecting 300,000 Canadians. One in 3 epilepsy patients have refractory seizures meaning that all antiseizure drugs fail to control their seizures. This drug resistance in epilepsy may be related to the over expression of multidrug resistance proteins (MDR). Varapamil inhibits MDR. We propose to add verapamil/placebo to patients' anti epilepsy medication for 3 months. Patients who receive placebo will have verapamil added for 3 months after the completion of the double-blind treatment period. Seizure frequency/severity will be tracked. Blood samples for DNA will be collected. There will be 9 clinic visits over 32 weeks. ECG and echocardiogram will be done at baseline and repeated if necessary

NCT ID: NCT01097499 Not yet recruiting - Analgesia Clinical Trials

Low Level Laser (LED) Use to Increase Dental Implant Stability and Post Operative Analgesia

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

Study hypothesis: Low level laser (LED) will reduce initial bone resorption and improve primary stability of dental implant. It will also reduces post operative pain compared to patient without treatment Implant osseointegration depends on many factors including biocompatibility of implant materials, design, surface, surgical access, patient conditions, biomechanical status, and lack of primary stability. Several in vivo and in vitro studies showed the healing effect of low level laser therapy (LLLT) on bone by decreasing the initial bone resorption postoperatively and increasing the primary stability of the implant. It has also shown to have an analgesic effect intraorally when used post intraoral surgical procedures. The exact mechanism is unclear despite the fact that many hypothesis has been proposed. In our study, our goal is to present, in a randomized standardized clinical trial, the effect of LLLT on post operative implant stability assessed by resonance frequency analysis (RFA). We will assess the subjective measures of postoperative pain using visual analog scale (VAS).

NCT ID: NCT01054040 Not yet recruiting - Clinical trials for Cardiovascular Disease

The Impact of Portion Plates for Weight Loss on Cardiac Rehabilitation Patients

Start date: February 2010
Phase: N/A
Study type: Interventional

The study will involve cardiac rehabilitation clients and will measure their weight, height, waist circumference and blood pressure comparisons between first and final visit (after 8 weeks). A control group will receive usual care and an experimental group will receive usual care plus a portion control plate for their meals. Patients currently have their waist circumference, weight, height and blood pressure measured at their first visit (week 0) and at their final visit (week 8). This study would compare these three parameters at these same times (week 0 and week 8) between the control and experimental groups. The control group would receive the usual care while the experimental group would receive usual care plus be given a portion control plate at week 0. The hypothesis of this study is that subjects from the experimental group will have an average reduction in: (a) waist circumference by > 5%, (b) weight or BMI by > 5%, and (c) systolic and diastolic blood pressure by >10%. The subjects in the control group are hypothesized to show an average less than these targets for the experimental group.

NCT ID: NCT01038908 Not yet recruiting - Breast Cancer Clinical Trials

Breast Lymph Node Mapping

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

The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.

NCT ID: NCT00994149 Not yet recruiting - Hypoglycemia Clinical Trials

Diazoxide In the Management Of Hypoglycemic Neonates

DIMOHN
Start date: October 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Diazoxide is an oral hyperglycemic medication. Diazoxide has been proven effective for treating hypoglycemia in infants and children with some types of persistent hyperinsulinemic hypoglycemia. The mechanism of action results in decreased insulin secretion. One of the causes of hypoglycemia in infants of diabetic mothers occurs due to a transient hyperinsulinemic state postnatally. The investigators have clinical experience and success using diazoxide in their unit for patients with hypoglycemia not adequately managed with intravenous (iv) dextrose and enteral supplementation. In this randomized controlled study the investigators expect that by using diazoxide as the initial treatment for infants of diabetic mothers with asymptomatic hypoglycemia (blood glucose of 2.5 to 2.0mmol/L), the investigators will be able to decrease the number of infants requiring an intravenous by at least thirty percent.

NCT ID: NCT00961987 Not yet recruiting - Pregnancy Clinical Trials

Innovation to Providing Interprofessional Maternity Care

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

The aim of this pilot project is to determine if there are differences in patient outcomes and healthcare utilization between patients randomly assigned to usual care (a collaborative model of maternity care with co-located healthcare professionals but with referrals to off-site obstetricians) or to a collaborative model of maternity care with co-located healthcare professionals, including obstetricians. It is hypothesized that by creating a seamless interface between obstetrical consultation and ongoing longitudinal maternity care, patient outcomes (birth outcome data), patient satisfaction and healthcare utilization, including number of outpatient visits, ultrasounds, laboratory tests, consultations, etc, will be improved in the intervention group compared with the group receiving usual care. The results could potentially lead to other sites adopting this innovative model of maternity healthcare delivery.

NCT ID: NCT00955578 Not yet recruiting - Clinical trials for Segmental Dysplastic Nevi

Genetic Identification (ID) of Segmental Dysplastic Nevi

Start date: August 2009
Phase: N/A
Study type: Observational

The investigators' goal is to identify the mutation in the gene that is responsible for the development of segmental dysplastic nevi. To identify the gene the investigators may use a candidate gene approach (i.e. sequence specific genes that are thought to be involved: NRAS, BRAF, etc) or a genome-wide approach trying to implicate regions in the genome (Loss-of-heterozygosity or copy number changes on comparative genomic hybridization).

NCT ID: NCT00933478 Not yet recruiting - Clinical trials for Patulous Eustachian Tube Dysfunction

A Trial of Clay Weight on the Ear Drum for Patulous Eustachian Tube

Start date: July 2009
Phase: N/A
Study type: Observational

The Eustachian tube is a tube that connects the back of the nose with the ear. Its job is to keep the pressure on the inside of the eardrum close to the pressure outside the eardrum, so that the eardrum can vibrate properly. Usually this tube is closed, but it opens briefly during swallowing. In the condition called patulous eustachian tube, this tube is open all the time. This is a benign condition but it can be very bothersome to patients. The incidence of patulous Eustachian tube dysfunction is about 0.3-6.6% of the population. However, about 15% of the people who have this condition are bothered enough by it that they seek medical attention. This condition is more common in females than males and is more common in adults than children. Some of the common symptoms of patulous eustachian tube can include roaring tinnitus synchronous with nasal respiration, audible respiratory sounds, sensation of a plugged ear and fluctuating aural fullness. In most cases the cause is idiopathic. Some predisposing factors include weight loss, stress,anxiety,fatigue, pregnancy, and temporomandibular joint syndrome. It can also be caused by adhesions in the nasopharynx following surgery on the adenoids. Sometimes it can be associated with medications such as diuretics and oral contraceptives. Neuromuscular disorders that cause atrophy such as multiple sclerosis, stroke and motor neuron disease have also been postulated to cause patulous eustachian tube. The purpose of this trial is to learn more about the condition and help us learn about how the eardrum might be treated to prevent it vibrating with sounds or noises coming up the Eustachian tube. The first part of the study will consist of a questionnaire to help to further define the symptoms of patulous eustachian tube, and to measure how severe these symptoms are. Currently there are few treatments that are satisfactory for patients. Common surgical therapies include injections of various substances into the Eustachian tube opening including paraffin, Teflon,or gelfoam. Unfortunately, these methods are either temporary or have lead to serious complications including cerebral thrombosis and death (due to inadvertent injection into the carotid artery). Other treatments have focused on cauterizing the Eustachian tube opening but these have been either unsatisfactory or caused damage to the trigeminal nerve. Myringotomy and insertion of a ventilation tube has helped some patients but others have found that this increased the patient's discomfort. The investigators have been treating patients recently by placing some putty like clay material on the eardrum, which stops it vibrating so much with the patient's own voice, and this appears to be quite effective for many patients. It is also easily removed if the patient does not find it helpful. However, the investigators do not really have a good idea of exactly which patients are helped by this, and which are not, and just how much their symptoms are helped, as well as how long the treatment helps them for.