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NCT ID: NCT02289287 Terminated - Stroke Clinical Trials

Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.

Start date: April 17, 2017
Phase: N/A
Study type: Interventional

Stroke is defined as a sudden vascular accident that causes brain damage and neurological impairment. Literature shows that a stroke has a negative effect on participation. Self-Management (SM) is defined as health promotion and education programs used mostly for people with chronic diseases, which aim at helping patients to maintain a feeling of wellness. The primary aim of this study is to assess the effectiveness of a group-based SM program for post-stroke patients in a community setting, and its contribution to improving participation, compared to standard care.

NCT ID: NCT02287103 Recruiting - Breakfast Clinical Trials

Eating vs Skipping Breakfast on Postprandial Hyperglycemia After Lunch and Dinner in T2D

SkippB-T2D
Start date: April 2015
Phase: N/A
Study type: Interventional

Background: Skipping breakfast and/or overeating at evening, has been associated in type 2 diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also associated with increased plasma free fatty acids (FFA) along the morning until lunch. High plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize that compared to eating breakfast the prolonged overnight fasting caused by the breakfast omission will result in increased postprandial glycemic response after subsequent isocaloric lunch and dinner in T2D individuals. Objectives: With this aim will study T2D patients in randomized crossover design to consume in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same caloric content. Methods and Study Design: The YesB intervention will consist on three identical meals coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB intervention the breakfast will be omitted and the subject continue fasting until lunch. Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at 19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at the same time point the blood samples will be collected after 8:00 when the breakfast will be omitted. Expected results: The investigators expect that compared to NoB condition, in the YesB condition the postprandial response after lunch and dinner will be reduced for glucose and for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and dinner will be enhanced

NCT ID: NCT02285062 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma

ROBUST
Start date: February 17, 2015
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

NCT ID: NCT02283853 Active, not recruiting - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

CONNECT
Start date: August 28, 2014
Phase: Phase 3
Study type: Interventional

The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric subjects with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306.

NCT ID: NCT02283281 Recruiting - Anxiety Clinical Trials

Anesthetic Premedication With a Cannabis Extract (Cannapremed)

Cannapremed
Start date: May 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Clinical evidence about the effects of cannabis in a perioperative setting or for the management of acute pain is rather scarce, mostly consisting of case report-based opinions on adverse events during or after general anesthesia after smoking cannabis, experimental pain trials in healthy volunteers, and a few clinical trials using different drugs, dosages and routes of administration. It is difficult to draw strong conclusions from the available evidence, that may seem sometimes even contradictory, mainly due -the investigators believe- to the many sources of variability in the study designs (e.g.: heterogeneity of the study samples, underpowered, unblinding, lack of randomization, timing of the therapeutic intervention, different experimental pain models, inclusion of different kind of surgical pain, etc.). Nevertheless, expert's opinion after a critical review of the literature is that cannabis and cannabinoids may have a beneficial role in the management of acute post-operative pain and nausea, at least for a selected group of patients and through an appropriate therapeutic intervention. Therefore, it seems to us pertinent to carry out an investigation in order to re-evaluate the issue of perioperative cannabis use through a sufficiently powered and controlled clinical trial. Some of cannabis effects such as sedation, bronchodilation, dryness of respiratory secretions, vein dilation, and increase of heart rater without producing hypertension, make of it an attractive option for pre-medication; while its antiemetic properties and its analgesic potential without causing respiratory depression may be profitable for the post-operative period. Cannabis oil seem to be most suitable to our investigation. The co-administration of tetrahydrocannabinol (THC) with cannabidiol (CBD) may translate into additional therapeutic benefits with an attenuation of adverse effects. The investigators expect to obtain less sedation, milder "high", lower incidence of anxiety, tachycardia, and hyperalgesia, as compared with THC-only acute pain trials.

NCT ID: NCT02283073 Active, not recruiting - Clinical trials for Parkinson's Disease, Idiopathic

Study for the Early Diagnosis of Parkinson's Disease

Start date: November 2014
Phase:
Study type: Observational

The main objective of the study is to design and validate the blood based PDx gene expression and miRNA assay for the early diagnosis of Parkinson's disease patients. Differential diagnosis includes patients with Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia, Essential Tremor and Normal Controls.

NCT ID: NCT02282020 Completed - Clinical trials for Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity

Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments

SOLO3
Start date: February 6, 2015
Phase: Phase 3
Study type: Interventional

Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.

NCT ID: NCT02281825 Completed - Depression Clinical Trials

Correlating Real and Virtual World Behavioral Fluctuations in Adolescence

Start date: November 2014
Phase: N/A
Study type: Observational

The present study will explore a new approach to ongoing evaluation and monitoring of fluctuations in personality traits via commercial video games. The aim of this longitudinal study is to examine the influence of everyday life event on video games performance as a function of individual differences in gaming behavioral patterns. focusing on the ongoing performance vacillations of the patient on commercial video games will offer insights in to possibly new generation of real time assessment medium of ongoing behavior.

NCT ID: NCT02281799 Withdrawn - Clinical trials for Inflammatory Bowel Diseases

Thiopurine Induced Pancreatitis in IBD Patients

Start date: March 2015
Phase: Phase 4
Study type: Interventional

Azathioprine (AZA) and its metabolite 6-mercaptopurine (6-MP) were developed over 50 years ago by Gertrude Elion and George Hitchings and were initially used clinically in the management of childhood leukemia and organ transplantation. The first case report of 6-MP use in inflammatory bowel disease (IBD) was from 1962 , and since then the use of thiopurines has been well established in the management of moderate to severe IBD. Thiopurines offer an inexpensive and effective treatment option for maintenance of remission of IBD in comparison to biological agents which may be 30 times more expensive . Although 50-60% of IBD patients respond to thiopurines, a significant proportion of patients will not tolerate them due to various adverse effects . The adverse effects of thiopurines may be dose related, patient related or idiosyncratic. The immunosuppressive effects of thiopurines also increase the rates of opportunistic infections. Thiopurines are also associated with a higher rate of malignancies, particularly a malignant Burkitt-like lymphoma, related to Epstein-Barr virus infection . Other adverse effects of thiopurine relate to allergic phenomenon. An idiosyncratic adverse effect of thiopurine use is acute pancreatitis (AP). Acute inflammation of the pancreas defined by INSPPIRE criteria: requiring 2 of: 1. Abdominal pain compatible with AP 2. Serum amylase and/or lipase ≥ 3 times upper limits of normal 3. Imaging findings of AP Drug induced AP is the assumed diagnosis when no other cause of AP can be found, the patient is taking a drug known to be associated with AP, and symptoms resolve after drug discontinuation. If pancreatitis re-occurs on re-exposure, the drug is definitely considered the cause. While drugs are considered a rare cause of AP and most cases are mild and self limited , there is an 8 fold higher risk of AP in IBD patients treated with AZA . Thiopurine induced AP is usually detected within 4 weeks of starting treatment. However in the case of thiopurine induced AP, there has been no clear understanding of the mechanism. Thiopurine induced AP is generally considered an indication to cease thiopurine therapy, due to the assumed risk of recurrence of AP on reintroduction. There exists several case reports and anecdotal evidence that reintroducing thiopurines following an assumed thiopurine associated AP can be well tolerated. The investigators hypothesize that AZA and/or 6-MP can be safely reintroduced in the management of IBD patients following thiopurine-induced pancreatitis. If in the past the patients were treated with AZA, they will now be commenced on 6-MP, and if in the past they were treated with 6-MP, they will be commenced on AZA.

NCT ID: NCT02281669 Not yet recruiting - Clinical trials for Cutaneous Leishmaniasis

Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients

Start date: November 2014
Phase: N/A
Study type: Observational

Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local treatment available is intralesional (IL) Pentostam injection. During the current study the investigators will monitor the adverse effects of this treatment and will follow up the recovery of the lesions after Pentostam injections.