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NCT ID: NCT01545102 Not yet recruiting - Cardiac Failure Clinical Trials

Assessment of Exercise Intensity in Cardiac Rehabilitation Programmes for Patients With Chronic Heart Failure

Start date: April 2012
Phase: N/A
Study type: Observational

Cardiac rehabilitation is the ideal comprehensive intervention for patients with chronic heart failure (CHF), since it addresses the complex interplay of medical, psychological and behavioural factors facing these individuals. Structured exercise training within a cardiac rehabilitation programme is firmly recommended for these patients. However, it is questionable whether patients are achieving an adequate dose of exercise to provide optimal benefits. The essential components for setting optimal training include the appropriate mode, duration, frequency and intensity of exercise. UK surveys of cardiac rehabilitation describe the frequency and duration of training, but here is scant information on exercise intensity. However, it is apparent that randomised controlled trials of exercise training use doses more than 4 times greater than in UK current practice. The Eastbourne Exercise Cardiology Research Group has demonstrated that although patients benefit from improved quality of life and submaximal fitness after a hospital outpatient cardiac rehabilitation programme, they do not achieve the increases in important prognostic indicators reported by the majority of exercise training trials. The critical factor in terms of eliciting a sufficient training effect while minimising risk is the intensity of the exercise performed. It is now widely accepted that the traditional methods of using fixed percentages of maximal heart rate or oxygen uptake to set exercise intensity include serious errors. The European Society of Cardiology recommends that cardiopulmonary exercise testing should be used to provide an objective evaluation of the metabolic demand of exercise. This allows physiologically meaningful reference points to be established for aerobic exercise prescription and is the solution to defining safe and effective training intensities. The next step is to determine whether this information can be transferred to a practical cardiac rehabilitation environment to set and monitor exercise intensity

NCT ID: NCT01546129 Not yet recruiting - Labor, Second Stage Clinical Trials

Effect of Dianatal Obstetric Gel (Cross-linked Polyacrylic Acid) on Outcomes in Vaginal Delivery

Start date: April 2012
Phase: Phase 3
Study type: Interventional

Perineal massage at the end of labor stage 2 has been investigated in 2 randomized controlled trials using a water soluble lubricant. In one trial a significant reduction of labor stage 2 has been found, both trials did not show a significant increase of perineum integrity. In the HCB Swiss Study both a significant reduction of labor stage 2 by 30 % as well as a significant increase of perineal integrity have been shown. No adverse events have been reported. (see also Obstetric gel shortens second stage of labor and prevents perineal trauma in nulliparous women: a randomized controlled trial on labor facilitation. Schaub AF, Litschgi M, Hoesli I, Holzgreve W, Bleul U, Geissbuhler V. J Perinat Med 2008; 36 (2): 129-135). Today's practice- Lubricants are widely used to enable manual vaginal examination during labor. In Israel midwifes are using Almond Oil for perineal massage at the end of labor stage 2 to protect the perineum. It has been shown for the first time that the use of the Dianatal Obstetric Gel facilitates vaginal childbirth in humans. Dianatal has been introduced to the EU markets in 2008.

NCT ID: NCT01546441 Not yet recruiting - Aging Clinical Trials

IMPACT Plus: The Integrated Complex Care Clinic

Start date: April 2012
Phase: N/A
Study type: Interventional

The "IMPACT Plus" Integrated Complex Care Clinic will create a team model of simultaneous interprofessional consultation and planning that brings together patients with complex or multiple chronic diseases, significant others/caregivers, the primary care team, community care providers and, uniquely, secondary consultation in real time at the primary care site. The purpose of this study is to evaluate whether the IMPACT clinic will reduce admission to hospital and visits to the emergency department (ED) in comparison to a control (usual care) group during a one year period of observation. Chart audits will be conducted on a monthly basis to calculate patients' complexity scores and data on all health services provided during the intervention phase, and compared between the intervention and control group. Additionally, surveys and semi-structured interviews aimed to measure patient, caregiver, and healthcare professional satisfaction of the IMPACT+ prior to and after initial assessment will be collected.

NCT ID: NCT01546805 Not yet recruiting - Blepharospasm Clinical Trials

Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm

Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.

NCT ID: NCT01548755 Not yet recruiting - Tachycardia Clinical Trials

The Western Galilee Hospital in Nahariya Home Monitoring Registry

Start date: April 2012
Phase: N/A
Study type: Observational

The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.

NCT ID: NCT01553370 Not yet recruiting - Overweight Clinical Trials

Randomized Controlled Trial of Milk Products and Physical Activity on Body Composition and Health in Overweight Young Males

Start date: April 2012
Phase: N/A
Study type: Interventional

Maintaining a healthy body weight is a major challenge for the majority of Canadians. A lifestyle strategy that promotes maintenance of a healthy body weight and, perhaps most importantly, can be incorporated into daily life with relative ease is essential. This study will determine if an effective strategy includes increased physical activity in conjunction with higher intakes of dairy products immediately following exercise. Fifty-six overweight adult males who do not regularly exercise will be assigned to one of four groups for 12 weeks. All groups will preform 12 weeks of exercise training (1 hour of cycling per day, 5 times per week). Two groups will consume supplemental low fat milk (3 servings per day) with one these groups consuming it immediately after exercise while the other will consume it either well before or long after the exercise session. The other two groups will consume a carbohydrate drink that has the same amount of energy as the low fat milk, with one of these groups consuming the drink right after exercise and the other another group will consume it either well before or long after the exercise session. Markers of health status including body weight, muscle mass, and bone mass will be measured at the start and after the 12- week intervention. The investigators anticipate that providing the low fat milk immediately after exercise will result in the most favorable changes in health outcomes, and provide a realistic lifestyle intervention for overweight individuals to attain a healthy body weight, and by doing so, optimize their ability to prevent chronic disease.

NCT ID: NCT01553799 Not yet recruiting - Focus of Study Clinical Trials

Use of Ultrasound Technology to Check Proper Placement of Tracheal and Endobronchial Tubes

Start date: April 2012
Phase: N/A
Study type: Observational

tracheal and endobronchial misplaced will be checked quickly qith US

NCT ID: NCT01555580 Not yet recruiting - Myasthenia Gravis Clinical Trials

A Pilot Study of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Generalized Myasthenia Gravis

Start date: April 2012
Phase: Phase 0
Study type: Interventional

The purpose of this study is to determine whether the drug Leukine (GM-CFS) is safe and tolerated by patients with autoimmune myasthenia gravis (MG).

NCT ID: NCT01555658 Not yet recruiting - Clinical trials for Coronary Artery Disease

Bivalirudin Plus Stenting in Long Lesion to Avoid Periprocedural Myocardial Necrosis Trial

BILLION
Start date: April 2012
Phase: Phase 3
Study type: Interventional

Background: Randomized trials show improved outcomes among acute coronary syndrome (ACS) patients treated with Bivalirudin1. Optimal antithrombotic treatment in patients undergoing percutaneous coronary intervention (PCI) is crucial to balance the risk of post-PCI bleeding versus ischemic complications2. Bivalirudin, a direct thrombin inhibitor has been extensively investigated as an intra-procedural antithrombotic therapy in patients with stable angina, Non ST-segment elevation acute coronary syndrome (NSTE-ACS), and ST-segment elevation myocardial infarction (STEMI). Bivalirudin, when used with or without glycoprotein IIb/IIIa inhibitors (GPI) during PCI has been found to be superior to Unfractionated heparin (UFH) with or without GPI in reducing 30-day bleeding complications without significant increase in the rate of ischemic events3-5. Moreover,after otherwise successful PCI,an increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients6. Recent studies have focused their attention onthe reduction of infarct size and the incidence of periprocedural (type IVa) myocardial infarction (PMI)after elective PCI7-8. Therefore, we will perform a single-center, prospective and randomized study to assess if Bivalirudin versus UFHis effective in preventing elevation of biomarkers of MI after coronary stent implantation in patients already treated with aspirin and clopidogrel,with anatomically complex lesion. Objective: to assess the safety and efficacy of routine usage of the Bivalirudin vs UFH in patients with coronary artery disease (CAD), after stent implantation in coronary long lesions, to avoid periprocedural myocardial necrosis. Setting: Single-center, spontaneous, prospective, randomized 1:1 study of Bivalirudin infusion vs UFH in the setting of CAD, after PCI with stenting incoronary long lesions. Comparison: Bivalirudin vs UFH, in preventing elevation of biomarkers of MI after coronary stent implantation in patients already treated with aspirin and clopidogrel, with anatomically complex lesion. Population:Patients with diffuse CAD undergoing percutaneous treatment on a native coronary vessel with planned implantation stents in overlapping with a total stent length >33 mm for long coronary lesions in vessels with a reference vessel diameter 2.25-4.0 mm. Assessment Following the procedure, blood samples for CK, CK-MB and Troponin will be collected at 6,12 and 24 h post PCI. CK-MB values will be considered abnormal if they will elevate above the upper limit of normal (ULN). This is set at 6 mg/L by our local laboratory. If the first blood sample showed a CK-MB level ≥18 mg/L (≥3 times upper normal limit), a second blood sample would be drawn every 8 h later until a downward trend will be observed. For patients with two or more blood samples drawn, the peak CK-MB level will be used for analysis. End-points: The primary end-point of this study will be the incidence of periprocedural myonecrosis that was defined as a peak post-procedural CK-MB elevation > 1 time the upper limit of normal (ULN) alone or associated with chest pain or ST-segment or T-wave abnormalities, in patients undergoing non-urgent PCI. Secondary end-points will be the rate of MACCE (major adverse cerebro-cardiovascular events, ie the composite of death, myocardial infarction [defined according to the Academic Research Consortium statement], target vessel revascularization or stroke), the rate of major bleedings (Bleeding Academic Consortium [BARC] 3-5), minor bleedings (BARC 2), and the rate of NACE (net adverse clinical events, ie the composite of MACCE and major bleedings) at 30 days, 6 and 12 month follow-up. Adverse events will be determined by telephone interview and/or medical record review. Clinical follow-up: telephone-based interviews and office-based direct visits will be performed at 1, 6 and 12 months, respectively, for end-point adjudication. Sample size and statistical analysis: Given an expected rate of abnormal post-procedural peak CK-MB > 1 x ULM of 48% (based on results of the INSTANT trial) for the control group and 29% for the experimental group (thus a 40% relative risk reduction), aiming for a 0.05 alpha and 0.80 power, a total of 204 patients will need to be enrolled (102 patients per group).

NCT ID: NCT01557153 Not yet recruiting - Depression Clinical Trials

Vascular Augmentation of Late-life Unremitted Depression (VALUeD)

VALUeD
Start date: April 2012
Phase: Phase 3
Study type: Interventional

Depression has a high occurrence and causes other problems in older people, two thirds of these patients will not have a lessening in their condition from routine treatment medication. About half have a form of depression known as 'vascular depression'. Augmentation, the addition to, antidepressant treatment with a vascular type of treatment (such as a group of medications called Calcium Channel Blocker including the medication called amlodipine) may be effective in this group of patients but previously published studies have been from highly selected specific patient groups. The investigators would like to find out if giving amlodipine medication to people with late life non-responding vascular depression would be acceptable to this patient group. The investigators would also like to know how they feel while having the treatment and whether this provides a measurable benefit for those patients and whether those benefits are relevant to the patients. The investigators would also like to find out the information the investigators need to plan and prepare for a larger version of this study.