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NCT ID: NCT00845936 Not yet recruiting - Clinical trials for Drug Induced Weight Gain

Metformin for Weight Control in Adolescents Taking Atypical Antipsychotics

Start date: May 2009
Phase: Phase 4
Study type: Interventional

Atypical antipsychotics (AA) are broadly used to treat a variety of psychiatric and neurological disorders in children and adolescents. Weight gain is a common side effect of these drugs. AA induced weight gain can be the cause of the metabolic syndrome which is a major health concern, as well as cancer and significant psychological disorders. Weight gain may also lead to low compliance with AAs. A number of studies have been conducted in order to find a way to prevent, reduce or reverse AA induced weight gain in children and adolescents, but so far there is no commonly accepted treatment for the problem. Metformin is an antihyperglycemic drug, approved by the FDA for treatment of type 2 diabetes in children older than 10 years of age. The drug usually does not cause hypoglycemia, even in high dosage. Contraindications include renal impairment, hepatic disease, a past history of lactic acidosis (of any cause), cardiac failure requiring pharmacological therapy, or chronic hypoxic lung disease. The drug also should be discontinued temporarily prior to the administration of intravenous contrast media and prior to any surgical procedure. The reported incidence of lactic acidosis during metformin treatment is less than 0.1 cases per 1000 patient-years, and the mortality risk is even lower. Acute side effects of metformin, which occur in up to 20% of patients, include diarrhea, abdominal discomfort, nausea, metallic taste, and anorexia. These usually can be minimized by increasing the dosage of the drug slowly, when indicated, and taking it with meals. Intestinal absorption of vitamin B 12 and folate often is decreased during chronic metformin therapy, and calcium supplements reverse the effect of metformin on vitamin B12 absorption. Three studies have studied the effect of metformin on weight gain secondary to use of AAs in adults and 3 other studies studied the effect of metformin in children and adolescents. Most of these studies have proved the drug to be efficient. No serious side effects have been demonstrated in any of these studies. Objective- To assess the effect of metformin on body weight of children and adolescents treated by AAs. Setting- recruitment and follow up would take place in the pediatric ward and outpatient clinic at the Ness- Tziona Mental Health Center. Participants- 30 adolescents aged 12- 20 years old, treated with AAs, who are overweight as defined by more than 10% of what is expected according to age and height. Importance of the Study 1. Identify a medication capable of reducing or preventing weight gain by an AA agent. 2. Identify an agent capable of improving compliance due to lower side-effect profile of AAs.

NCT ID: NCT00845884 Not yet recruiting - Clinical trials for Advanced Gastric Cancer

Phase I/II Study of Weekly Docetaxel and Cisplatin Together With Capecitabine and Bevacizumab in Advanced Gastric Cancer

Start date: February 2009
Phase: Phase 1/Phase 2
Study type: Interventional

In spite of multiple attempts to improve the efficacy of first-line chemotherapy in advanced gastric cancer, the progress that has been achieved so far is rather limited, and many investigators are exploring newer regimens.A combination of decetaxel (Taxotere) with Cisplatin and 5-fluorouracil (5FU) is considered one of the most effective regimens in this disease. However, it is associated with significant toxicity which avoided its general adaptation by the medical community. The current study is exploring a newer way to administer these three drugs, hopefully making the regimen more comfortable, less toxic and maybe even more effective. We will do this by changing the dose and timing of Taxotere and Cisplating, by replacing protracted infusion of 5FU with tablets of Capecitabine (Xeloda) and by adding the anti-angiogenic drug, Bevacizumab (Avastin), which had shown encouraging results in this disease.

NCT ID: NCT00845793 Not yet recruiting - Type 2 Diabetes Clinical Trials

The Meal Tray as a Tool and Platform to Change Eating Habits Among Hospitalized Diabetic Patients - An Intervention Study

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

This protocol is intended to test whether a focused nutritional intervention in hospitalized patients with type 2 diabetes can have an impact on long term eating habits, physical activity and anthropometric parameters. The rational is to use the food tray as a means of conveying simple and practical nutritonal and behavioral messages.

NCT ID: NCT00843648 Not yet recruiting - Clinical trials for Antibody Immune Profile

Study of the Development of Human Immune System of Newborns by Antigen Chips

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

The immune system is a dynamic, constantly evolving network. Excluding autoimmune diseases, healthy individuals are also known to have a large number of circulating antibodies that can recognize proteins of their own tissues. These antibodies are known as natural antibodies and previous studies suggested that some features of these "self" components are shared by individuals in certain physiological states. Thus, monitoring self immunoglobulins can provide an overview of the various states of the immune system. To do so, and in the process to obtain systems biology view of the immune system, the newly developed Antigen Chip technology has been used. To further investigate this subject we plan to carry out broader investigations that will be conducted in collaboration with the group of Prof. Eshel Ben-Jacob from the university of Tel-Aviv and Prof. Irun Cohen from the Weizmann Institute that have the required experimental and analytical expertise and facilities. The studies will include follow-up on the immune state of babies and their mothers for several months post birth using the Antigen Chip and analyzed by the Immune holography method. The investigations will also include comparative studies between the immune signature of different body fluids, the effects of feeding, and the effect method and time of labor.

NCT ID: NCT00840710 Not yet recruiting - Labor Clinical Trials

Clinical Feasibility of Birth- Track II System

BT
Start date: February 2010
Phase: N/A
Study type: Observational

The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.

NCT ID: NCT00834145 Not yet recruiting - Right Heart Failure Clinical Trials

Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure

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

Mobilization of fluid from the legs with the Normatec pump in patients with right heart failure, may empty the "reservoir" in the legs from excessive fluid, enabling fluid overload to collect there rather than in the liver or in other third spaces. Thus, we hypothesize that patients will lose weight, feel better, look better, be less prone to infections in their legs and to congestion of the liver.

NCT ID: NCT00828022 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer

Measles Vaccine in Patients With Measles Virus-Positive, Advanced Non-Small Cell Lung Cancer

SMC4692
Start date: March 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The objectives of the study are to assess the efficacy and safety of live, attenuated measles vaccine as consolidation therapy in patients with measles-positive, non-small cell lung cancer with locally-advanced (stage 3B with pleural effusion) or metastatic (stage 4) tumors in remission.

NCT ID: NCT00822419 Not yet recruiting - Sternotomy Clinical Trials

Percutaneous Ketamine Versus Lidocaine for Mid-Sternotomy

Start date: February 2009
Phase: Phase 4
Study type: Interventional

Since midsternotomy is painful postoepratively, and since ketamine has been shown to be optimal postoeprative analgessic adjuvant, the investigators wish to assess its percutaneous preemptive effect, comparing it to lidocaine effect.

NCT ID: NCT00822133 Not yet recruiting - Postoperative Pain Clinical Trials

Percutaneous Ketamine Versus Lidocaine or Placebo, for Post-Surgery Analgesia, in Patients Undergoing Laparoscopic Partial Lung Resection

Start date: February 2009
Phase: Phase 4
Study type: Interventional

Since VAT bears with it severe postopearive pain, and since ketamine has been shown to be an optimal analgesics adjuvant for postoperative pain, we wish to assess to effects of ketamie vs. lidocaine if put on the skin in the sites where scopes are interset into the chest for thoracoscopy.

NCT ID: NCT00819078 Not yet recruiting - Smoking Cessation Clinical Trials

Comparative Study of SR Bupropion for Adolescent Smoking Cessation

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

Bupropion has been used successfully and safely for smoking cessation in adults. It was also used in very few studies among adolescent population. Our hypothesis is that Bupropion would be effective and safe among the adoelscent psychiatric population. A double-blind randomized controlled-trial will be held to determine that.