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NCT ID: NCT00215813 Available - Clinical trials for Chronic Fatigue Syndrome

Ampligen in Chronic Fatigue Syndrome

Start date: n/a
Phase:
Study type: Expanded Access

This is an open label study of Ampligen in patients with chronic fatigue syndrome.

NCT ID: NCT00244686 Available - Clinical trials for Hypereosinophilic Syndrome

This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Access for Patients With Hypereosinophilic

Start date: n/a
Phase:
Study type: Expanded Access

104317: The market authorisation application for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application. On the basis of sponsor's evaluation, participants with life-threatening HES who have documented failure (lack of efficacy or a contra-indication) to at least 3 standard HES therapies (compassionate use) and participants who have participated in a previous GSK sponsored study in HES (long-term access) can be consider for mepolizumab treatment where the country regulation permits. In this study, participants will receive mepolizumab in an open-labelled manner, and limited data will be collected to evaluate the long-term safety and efficacy of mepolizumab. 201956: This is a Long-term Access Programme (LAP) which aims to support provision of mepolizumab, until it is commercially available, to eligible subjects with severe asthma who participated in a GSK-sponsored mepolizumab clinical study in severe asthma. Eligible subjects will initiate mepolizumab within a 6-month period following the individual subject's last scheduled visit in their preceding clinical study. For each subject benefit versus risk will be assessed throughout the study to support continued treatment with mepolizumab. 112562: To provide a mechanism for expanded access to mepolizumab therapy for eligible patients with HES. Whenever possible, use of an investigational medicinal product by a patient as part of a clinical trial is preferable. However, when patient enrollment in a clinical trial is not possible (such as when the patient is not eligible for ongoing clinical trials or the patient is not able to attend investigational sites), appropriate patients may receive mepolizumab through expanded access. This expanded access protocol was designed to allow access to mepolizumab for HES patients with seriously debilitating or life-threatening disease that are not able to enroll in clinical trials, including those patients that have already participated in a mepolizumab clinical trial.

NCT ID: NCT00457548 Available - Wounds and Injuries Clinical Trials

Phone Intervention for Alcohol (ETOH) Use in Emergency Department Motor Vehicle Crash (ED MVC) Patients

DIAL
Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is to determine if a brief counseling intervention, delivered by telephone, is more effective than standard ED care, to reduce future alcohol related injuries and alcohol related negative consequences, among patients treated in the ED for injuries from an MVC and other injury mechanisms.

NCT ID: NCT00508963 Available - Clinical trials for Leishmaniasis, Cutaneous

Compassionate Use of Sodium Stibogluconate (Pentostam) for Cutaneous and Mucocutaneous New World Leishmaniasis

Start date: n/a
Phase: N/A
Study type: Expanded Access

Patients with biopsy proven new world cutaneous or mucocutaneous leishmaniasis will be treated with sodium stibogluconate (Pentostam).

NCT ID: NCT00575549 Available - Clinical trials for Evaluation of Troponin I Levels

Prospective Analysis and Comparison of Stress Echo to Real-Time Myocardial Contrast Stress Echo

Start date: n/a
Phase: N/A
Study type: Expanded Access

The purpose of this study is to prospectively analyze and compare conventional stress echocardiograms and real-time myocardial contrast stress echocardiograms; and to determine the effect of contrast agents used during real-time myocardial contrast stress echocardiograms on serum troponin I levels.

NCT ID: NCT00584064 Available - Clinical trials for Patent Foramen Ovale

Emergency/Compassionate Use PFO Occluder

Start date: n/a
Phase: N/A
Study type: Expanded Access

Emergency/compassionate use for the AMPLATZER PFO Occluder

NCT ID: NCT00704925 Available - Clinical trials for Lambert Eaton Myasthenic Syndrome

Treatment of Lambert-Eaton Syndrome With 3,4 DAP

Start date: n/a
Phase:
Study type: Expanded Access

A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome (LEMS). This is an expanded access trial, which means that although data from this study will be collected and reported to the US Food and Drug Administration (FDA)and the drug manufacturer, this is not a formal study of drug in LEMS. If you decide volunteer, you will be evaluated by a neurologist to determine your eligibility to receive 3, 4-DAP by a review of your medical history, medication regimen (the medications you are taking) and a neurological examination. If you are a female of child-bearing potential, a serum pregnancy test will be done to ensure that you are not pregnant. Once it is determined that this treatment is appropriate for your care, you will begin taking 3, 4 DAP by mouth in slowly increasing doses. Treatment will begin with 5mg three times a day, as clinically needed, and if tolerated. You will be monitored for strength and side effects by routine clinic visits at initial intervals of once a month, increasing to intervals of every 12 months as permitted. Blood will be drawn (approximately 1 tablespoon) at every clinic visit or as often as the investigator deems necessary to assess your liver/kidney function and blood counts. You will have an EKG (a test to see how your heart is functioning) at your first study visit, after 6 months of taking 3,4 DAP and again every 2 years. Treatment will be continued indefinitely if a good clinical response is achieved. This study is planned to last indefinitely. The dosage of 3, 4DAP is individually adjusted. The usual range is 10-15 mg 3-4 times per day for the full effect and will increase by 50% every two weeks to 10-15 mg three to six times a day, as needed and if tolerated. Dosages above the full effect level will not provide an additional benefit and should not be used. 3, 4 DAP is a convulsant (causes seizures). A total of 100 mg/day is the maximum dosage allowed.

NCT ID: NCT00752349 Available - Dysphagia Clinical Trials

To Evaluate Oral Phase Swallowing Function Using Submental Ultrasound

Start date: n/a
Phase: N/A
Study type: Expanded Access

Ultrasound is widely applied in many fields of medicine but less commonly used in the evaluation of tongue movement and swallowing abnormality. Fuhrman RAW reported the usefulness of using ultrasound to evaluate poor tongue coordination [1]. Peng CL stated that ultrasound could provide excellent quantitative and qualitative bases of tongue movement during swallowing using cushion-scan technique [2]. Videofluoroscopic swallowing study (VFSS) is widely accepted as the gold standard of evaluating swallowing abnormality because it is able to evaluate the whole swallowing procedure without interference of pharyngeal contraction and foreign body sensation when swallowing is examined by using a fiber-optic laryngoscope. One of the most important information that VFSS can provide is the detection of subclinical silent aspiration. The decision and management of many patients with swallowing abnormalities are usually based on the VFSS findings [3]. As shown in many reports, our experiences showed that VFSS provided extremely important information of understanding the pathophysiologic change of dysphagia due to variable etiologies, such as in patients with nasopharyngeal cancer suffering from radiation therapy [4] and in patients with stroke [5]. Using the findings of VFSS, physicians and medical staffs can make important decision whether oral feeding should be given, which safety swallowing maneuver works and what is the appropriate choices of food consistency safe to dysphagic patients. The difficulties of VFSS are usually in the transportation of paraplegic and hemiplegic patients from ward to the examining chair. The frequency and examination duration of VFSS is usually limited for avoiding unnecessary radiation exposure. Hence, ultrasound provides a role in evaluating oral condition with the benefits of convenience of transportation and availability as well as no radiation exposure. Therefore, validation of the value of ultrasound for the oral swallowing with correlation of VFSS is important to test the clinical feasibility. Peng CL et al reported their experiences of using real-time ultrasound in the evaluation of intrinsic tongue movement [2, 6, 7]. The findings of submental ultrasound are quite different from the findings of VFSS which provides the surface information of the tongue in the swallowing of radiopaque barium sulfate bolus. Combined real-time B mode and M mode ultrasound, it was reported the potential of digital data analysis of oral phase swallowing. Kuhl V et al reported the usefulness of ultrasound in the evaluation of laryngeal elevation in patients with dysphagia [8]. They found significant decrease of laryngeal elevation in patients diagnosed as neurogenic dysphasia [8]. Casas et al successfully combined ultrasound examination and plethysmography to evaluate the swallowing condition of children with cerebral palsy [9]. The results of these studies explained the potential of ultrasound in oral swallowing and dynamic laryngeal movement. Our experiences of VFSS showed the usefulness VFSS in diagnosing and management of patients with swallowing problem or dysphagia [4, 5, 10, 11]. To our knowledge, there was little experience of comparing between ultrasound and VFSS in patients with swallowing problem. Therefore, we conducted this study to correlate submental ultrasound and VFSS findings and tried to find out the clinical feasibility and usefulness. Purposes: This study was to evaluate the usefulness of submental ultrasound (SM US) in oral phase swallowing in correlation with videofluoroscopic study (VFSS). 1. To compare normal volunteers and patients with swallowing abnormality with submental ultrasound. 2. To evaluate and compare patients with swallowing problem using submental ultrasound and VFSS. Type of study: Retrospective. Time of study: Jan 2004 - July 2006.

NCT ID: NCT00764543 Available - Hydronephrosis Clinical Trials

Ambulatory Blood Pressure Measurement in Children With Congenital Urine Flow Obstruction

Start date: n/a
Phase: N/A
Study type: Expanded Access

Children with unilateral congenital urine flow impairment, who require surgery, have abnormal 24-hour ambulatory blood pressure measurements.

NCT ID: NCT00765531 Available - Hypercalciuria Clinical Trials

Hypercalciuria and Calcium Stone Disease in Caucasian Patients

Start date: n/a
Phase: N/A
Study type: Expanded Access

The hypothesis of this study proposal is that pediatric urinary stone formers have genetic risk factors which predispose their urinary stone production. 50-60% of pediatric stone patients have a positive family history of urinary stone disease. Several genetic mutations have been identified which predispose patients to various types of urinary stones. These genetic mutations can also lead to other significant sequela besides stones, including osteopenia/osteoporosis (bone loss). Furthermore, metabolic abnormalities can be identified in more than 50% of pediatric stone formers, some of which can be improved/alleviated with medical intervention to help decrease rate of stone formation and the need for hospitalization and surgical intervention.