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NCT ID: NCT01329068 Recruiting - Breast Cancer Clinical Trials

Patient Empowerment by Group Medical Consultations

GMC
Start date: April 2011
Phase: N/A
Study type: Interventional

Carriers of a BRCA mutation have a significantly increased risk to develop breast cancer in the course of their lives . They face a difficult choice: either a preventive removal of the breast(s) or an intensive inspection process. After primary treatment of breast cancer, patients will be followed for 5-10 years to diagnose recurrence or a new primary tumor in an early stage; to support the patient during hormonal treatment; to educate the patient about risk factors and healthy life style; and to provide psychosocial support. Currently, follow-up of breast cancer patients and surveillance of BRCA mutation carriers is offered in regular, one-to-one medical visits. Experience shows that in an individual visit it is often not possible to give all aspects that are important, enough attention. The group medical consultation (GMC) is a new form of medical visits where the physician or nurse practitioner performs a series of one-to-one consultations in the presence of 8 to10 other patients. A social worker accompanies this process. Patients in group consultations may gather more information because they learn from each other and there is relatively more time compared to a regular consultation. Research shows that both patients and caregivers are more satisfied with care after a group consultation compared to individual visits. After a GMC the participants from the breast cancer GMCs will be provided with a dedicated iPad for 3 months. Using this iPad, patients can contact the women they have met during the GMC as well as health care professionals by several communication channels, including virtual group meetings. This approach provides a unique combination of both social support and professional education concerning survivorship in an e-health environment.However, it is also known that group sessions may be counterproductive for some patients, for example because they are frightened by the stories of others. The goal of this study is to examine whether group visits (in combination with dedicated iPads) are beneficial to women with a BRCA mutation and for patients in follow-up after breast cancer.

NCT ID: NCT01330407 Recruiting - Burn Wounds Clinical Trials

Comparative Assessment of Adjuvant Effect of Cultured Epidermal Autografts Versus Skin Allografts on Wound Healing of Burns Treated With Widely Expanded Skin Autograft Using Meek Micrografting Technique MEEKADEAU

MEEKADEAU
Start date: April 2011
Phase: Phase 3
Study type: Interventional

The investigators intend to conduct a comparative, monocentric prospective double-blind study with intra-subject randomization, to compare the results on wound healing of 2 adjuvant treatments to Meek micrografting technique : Cultured Epidermal Autografts and cryopreserved skin allografts.

NCT ID: NCT01332240 Recruiting - Clinical trials for Stage III Lung Cancer

External ValidatIon Trial of ASTER Trial

EVITA
Start date: April 2011
Phase: N/A
Study type: Interventional

As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice in the staging of potentially resectable clinical stage III non-small cell lung cancer.

NCT ID: NCT01332877 Recruiting - Obesity Clinical Trials

Breakfast Size and Weight Loss in Overweight/Obese Adults

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

EFFECT OF HIGH CARBOHYDRATE AND HIGH PROTEIN BREAKFAST ON WEIGHT LOSS, GHRELIN, HUNGER AND CRAVING SCORES IN OBESE MEN AND WOMEN. D Jakubowicz, M Boaz, J Wainstein, O Froy Background: Obesity underlying endocrine, metabolic and eating behaviour features promotes weight gain, increase of hunger, and carbohydrate (Carb) craving. Restrictive diets either in calories or Carb produce withdrawal effect, that further exacerbate Carb craving resulting in rapid return of obesity. Meal timing and composition has shown to play a pivotal role in appetite regulation through several hormonal systems such as ghrelin. The investigators hypothesized that to be successful; a weight loss strategy must change the hormonal environment to increase satiety while reducing hunger and craving. Objectives: To assess weight loss, satiety, hunger, cravings and ghrelin response to two isocaloric diets. Additionally, these outcomes were measured in response to meal challenge. Methods: In this randomized, treatment controlled clinical trial, 146 obese, sedentary adults with impaired glucose tolerance will be assigned to Low carb diet (LCHbd) or an isocaloric diet with a high carb, high protein breakfast (HCPbd),1400 kcal for women and 1600 kcal for men. LCHbd breakfast will provide 300 kcal with carb: protein: fat of 13:40:48. HCPbd breakfast will provide 600 kcal with 50:20:30. From baseline until week 16 participants will take part in a supervised weight loss diet, followed until week 32 by a maintenance period. Anthropometric measures, OGTT for glucose and insulin, VAS-measured hunger and satiety and Food Craving Inventory Analysis will be performed at baseline, week 16 and week 32.

NCT ID: NCT01333176 Recruiting - Type 2 Diabetes Clinical Trials

Point of Care HbA1c as a Screening Test for Type 2 Diabetes in First Nations

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

1. Purpose - to estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a BC First Nation community - to determine the utility of community based screening by examining how many positively screened people follow up with the recommended subsequent testing and family physician visit - to determine if point-of-care HbA1c test (Ames/Bayer DCA 2000) correlates with the confirmatory fasting and 2 hour post challenge blood glucose tests. 2. Hypothesis The Point-of-Care test will correlate well with the gold standard diagnostic tests and prove to be a useful tool for community-based screening. This test obviates the need for fasting and repeat glucose tolerance testing.

NCT ID: NCT01333605 Recruiting - Hodgkin Lymphoma Clinical Trials

IGEV Followed by Autologous Transplantation for Refractory or Relapsed Hodgkin Lymphoma

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

The aim of study is to prove IGEV regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed Hodgkin lymphoma is effective.

NCT ID: NCT01333696 Recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Pemetrexed as Salvage Treatment in Squamous Cell Carcinoma of Head and Neck

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

The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

NCT ID: NCT01334320 Recruiting - Clinical trials for Oral Squamous Cell Carcinoma

Survival Benefit of Elective Neck Dissection in T1,2N0M0 Oral Squamous Cell Carcinoma

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

Controversy over surgical treatment of clinically negative neck in early stage oral squamous cell carcinoma revolves around the uncertainty of its impact on patient prognosis. The efficacy of elective neck dissection on prognosis in T1, 2 N0M0 patients continues to be the subject of clinical debate. Currently the clinically negative patients are treated by one of the two main policies: one is elective neck dissection; the other is "watchful waiting". The objective of this multi-institutional prospective randomized controlled study is to evaluate the survival benefit of elective neck dissection on the prognosis of T1, 2 N0M0 patients with carcinoma of oral cavity. The enrolled patients with T1, 2 N0M0 oral cancer will be randomized into two groups: elective neck dissection versus watch and wait. The survival rate and the recurrence rate between two groups will be compared. The result of the study will give surgeons evidence-based instructions for the management of clinically negative neck in patients with cancer of oral cavity.

NCT ID: NCT01335568 Recruiting - Liver Cirrhosis Clinical Trials

Hepatocyte Matrix Implant Study Indonesia

HMIIndo
Start date: April 2011
Phase: Phase 1
Study type: Interventional

This clinical investigation of the hepatocyte matrix implant is an evaluation blinded non-randomized and monocentric pilot study of Phase I, which is conducted as a therapeutic investigation. Randomization is not possible due to ethical and practical reasons. This study has already been approved in Switzerland and has been adapted to Indonesian Law and disease. This new treatment procedure has already been successfully used on the basis of compassionate use in Germany. The hepatocyte matrix implant is a new patented procedure consisting of bio-matrix technology. A formaldehyde-free special matrix consisting of self-dissolving polymers is applied as a carrier substance and is cultivated with human autologous cells using a special technique. Clinically the bio artificial liver replacement tissue for patients with end-stage hepatic disease has been developed as a first application. In this procedure autologous hepatocytic tissue and pancreatic tissue is removed (liver resection and pancreatic biopsy) from the patient in a first surgical procedure. The tissue is sent to a specialized Cell Culture Laboratory. The laboratory is GMP certified for this procedure. The cells are processed according to SOPs in a special perfusion procedure and prepared on several platelets of matrices (platelets of 20 mm diameter and 4mm thickness). After completion of the laboratory process the bio tissues are implanted into the mesentery of the small intestine during a second operation. The cells are growing controlled on the matrix, take on the capillaries of the patient and thus connect to the blood circulation. The implanted cells multiply by a specific factor and independently take over the metabolic function of the original liver after two to four weeks. In the following process the carrier matrix dissolves completely and implanted cells develop into liver cell tissue.

NCT ID: NCT01335711 Recruiting - Chronic Hepatitis C Clinical Trials

CHRONVAC-C Study Followed by Standard of Care in Chronic Hepatitis C Virus (HCV) Subjects

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

To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients.