Clinical Trials About "MasterControl preps increasingly complex regulatory environment" RSS

01:01 EDT 21st June 2018 | BioPortfolio

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Showing "MasterControl preps increasingly complex regulatory environment" Clinical Trials 1–25 of 1,800+


Abuse Liability of Reduced Nicotine Content Cigarettes Within a Complex Tobacco Marketplace: Experiment 1

Tobacco regulatory policies can have unanticipated consequences; therefore, methods that would permit prospective estimates of the effects of potential tobacco regulations are necessary for the development of tobacco regulatory science. The goal of this project is to experimentally assess how smokers purchase and consume reduced-nicotine cigarettes and how this is related to nicotine content and absorption. The proposed projects can directly inform tobacco regulation by providi...

A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex

The purpose of this study is to see if adding stavudine (d4T) to anti-HIV drug regimens (with or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems involving the brain or spinal cord) in HIV-positive patients.

Neurodevelopment in Infants With Complex Congenital Heart Defects

The primary goal of this study is to systematically describe early neurodevelopment using a complementary set of observational and neurophysiological measures that may predict cognitive and motor delays earlier than currently possible for infants with Complex Congenital Heart Disease (CCHD).

The Differential Effects of 3 Different Immunosuppressive

The study is a laboratory investigation comparing the regulatory effects of different immunosuppressive therapies in an in vitro human MLR assay of selecting specific immunosuppressive therapy to promote a regulatory profile and determining possibly newer accepted dosing and drug concentrations for agents most associated with this regulatory profile.

Gene-Environment Interactions in Complex Disease

To assess genetic variation in 87 different cardiovascular disease candidate genes and to measure the associations of these variants with cardiovascular disease and its risk factors.

Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure

T-Regulatory Cells in Amyotrophic Lateral Sclerosis

This is an open-label pilot study to determine the safety and tolerability of infusions of autologous CD4+ CD25+ regulatory T cells with concomitant subcutaneous IL-2 injections in 4 subjects with ALS.

Importance of CD4+CD25+ly in UC1. Investigation of Difference Between Blood Concentration IL 17, IL 33, Regulatory T ly in Patients With UC and Control Group

Mucosal inflammation in patients with UC is the result of immunosuppression disturbance because decreasing number of regulatory T ly and activation IL 17

Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome

A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain. The aim of the present study is to assess the validity of the ANI parameter in patients with Complex Regional Pain Syndrome treated with a nerve block (reversible pain).

Paediatric Resident Complex Care Curriculum RCT

Medical and technological advances have resulted in a growing cohort of children with medical complexity (CMC), many of whom would not have survived previously and are living and thriving within the community. These families have unique needs that have previously not been taught in the typical training programs for paediatricians. The goal of this project is to develop an evaluation of a national complex care curriculum and to identify whether dedicated educational modules have...

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.

Late Effect of Ablation on Premature Ventricular Complex Ablation

Premature Ventricular Complex (PVC) ablation is performed in certain indications. Generally acutely abolition of PVC at the time of ablation accepted as successful ablation. However in some patients this effect occurs lately. In this study investigators sought late effect of ablation

A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)

This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to receive CC-5013 10 mg/day orally. For each subject the study consists of two phases: Pre-treatment phase(1 wk) and treatment phase (12 wks)

Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1

PRIMARY: To assess the safety of nimodipine in the treatment of HIV-Associated Motor / Cognitive Complex (formerly AIDS dementia complex). To assess the systemic or central nervous system toxicities (e.g., rash, headache, gastrointestinal symptoms, nausea, dyspnea, muscle pain or cramp, acne) of nimodipine. SECONDARY: To assess the efficacy of nimodipine in stabilizing the progression of HIV-Associated Motor / Cognitive Complex by improvement in neuropsychological test p...

Natural Versus Synthetic Vitamin B Complexes in Human

In a cross-over study the investigators evaluate the effects of natural (Panmol-B-Complex) versus synthetic vitamin B complexes to identify the bioavailability of distinct vitamins as well as long-term effects. The primary hypothesis for this study: "Natural Vitamin B-complexes are as effective as synthetic Vitamin B-complexes or better." For this reason 30 subjects (18 to 65y; BMI >19 to

Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome

This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.

Messages for Increasing Dairy Consumption

Over 35,000 Canadians, 65% of men and 72% of women aged 31-50 years fail to consume the recommended number of milk and milk product servings (≤2 servings per day). Given the wide range of health benefits associated with increased dietary intake of milk and milk products the objectives of this study were to conduct a prospective, 5-arm randomised controlled trial in order to test the effectiveness of a variety of messages for increasing milk and milk product consumption in men...

Eylea Regulatory Post Marketing Surveillance(rPMS)

The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA.

To Motivate Elderly to Move

This study examines the short- and long-term-effects of different repeated frames in which an exercise program is offered on behavior (i.e., frequency of exercise) and motivation (i.e., autonomous/controlled) in older people (65+). The frames are manipulated experimentally as either prevention focused (e.g., to prevent worse health), promotion focused (e.g., to gain better health) or neutral (control condition).

Studies in Patients With Tuberous Sclerosis Complex

This study is aimed to carry out a systematic study to examine the effects of genetic variants (genetic modifiers) other than TSC genes on phenotypic variability in familial TSC patients (affected parent, child and unaffected siblings) and sporadic TSC.

Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental in suppressing adaptative immune responses, including B cells production of immunoglobulins. We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a quantitative and/or qual...

Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation

The objective of the study will be to evaluate the effect of different therapeutic immunosuppressive strategies currently employed in common clinical practice on regulatory T lymphocytes and to verify the hypothesis that the association of thymoglobulins - mTOR inhibitors - small doses of Tacrolimus not only represents a safe anti-rejection therapy but it can also lead to mid-term formation of a high amount of regulatory T cells and, consequently, a high grade of tolerance.

Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.

Mycobacterium Avium Intracellulare Complex (MAC) Study

This study is short course (3 month) multiple drug antibiotic therapy. The purpose of this research study is to evaluate the clinical and radiology response to assess whether drug resistance develops and assess quality of life measures with MAC disease.

Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)

The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease.

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