Search Results (1870)
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Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant
Objectives:
Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness (CIMT)
Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients.
First Posted: September 28, 2005
Condition(s): Carotid Artery Plaque, Arteriosclerosis, Obesity, Metabolic Syndrome X
Intervention(s): Rimonabant, Placebo (for Rimonabant)
Status: Terminated
Enrollment (expected or actual): 661
Allocation: Randomized
Sponsor: Sanofi
Principal Investigator:
Completion Date (primary or actual): April 2009
STRADIVARIUS (Strategy To Reduce Atherosclerosis Development InVolving Administration of Rimonabant - the Intravascular Ultrasound Study)
The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.
First Posted: July 27, 2005
Condition(s): Coronary Atherosclerosis
Intervention(s): Rimonabant (SR141716), Placebo
Status: Completed
Enrollment (expected or actual): 839
Allocation: Randomized
Sponsor: Sanofi
Principal Investigator:
Completion Date (primary or actual): October 2007
Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain
Investigators planned to adopt the N-of-1 trial approach to objectively test the effectiveness of ultra-micronized PEA at an individual level in our older outpatients. 65 years old or older persons referring to the Geriatric Unit of the Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico of Milan complaining of noncancer chronic pain of any origin will be eligible. Each trial will be a placebo-controlled randomized crossover trial including two um-PEA (600 mg twice a day) and placebo treatment pairs. Investigators will secondarily meta-analyse the performed N-of-1 trials to obtain an estimate of the average effect of um-PEA compared with placebo using a frequentist and Bayesian approach.
First Posted: March 4, 2016
Condition(s): Chronic Pain
Intervention(s): ultra-micronized palmitoylethanolamide, Placebo
Status: Completed
Enrollment (expected or actual): 11
Allocation: Randomized
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigator: Maura Marcucci, MD, MSc
Completion Date (primary or actual): July 2016
Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALS
Amyotrophic lateral sclerosis (ALS) is a fatal disease leading to motor neuron degeneration and progressive paralysis. Other studies have revealed defects in skeletal muscle even in absence of motor neuron anomalies, focusing on acetylcholine receptors (AChRs) and supporting the so-called "dying-back" hypothesis. Outcome of this study will be to understand if the endocannabinoid palmitoylethanolamide (PEA) can reduce the rundown of AChRs currents in ALS muscle, and if it can modify ALS patients' clinical and electrophysiological parameters.
First Posted: January 1, 2016
Condition(s): Amyotrophic Lateral Sclerosis
Intervention(s): endocannabinoid palmitoylethanolamide (PEA), Riluzole
Status: Completed
Enrollment (expected or actual): 50
Allocation: Randomized
Sponsor: University of Roma La Sapienza
Principal Investigator: Maurizio Inghilleri, Associated Professor of Neurology
Completion Date (primary or actual): June 2015
Obese Patients With or Without Comorbidities (RIO-North America)
To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities
First Posted: January 24, 2002
Condition(s): Obesity, Weight Loss
Intervention(s): Rimonabant (SR141716)
Status: Completed
Enrollment (expected or actual): 3045
Allocation: Randomized
Sponsor: Sanofi
Principal Investigator:
Completion Date (primary or actual): April 2004
Obese Patients With Type 2 Diabetes
To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes
First Posted: January 24, 2002
Condition(s): Obesity, Diabetes Mellitus, Non-Insulin-Dependent, Obesity in Diabetes
Intervention(s): Rimonabant (SR141716)
Status: Completed
Enrollment (expected or actual): 1045
Allocation: Randomized
Sponsor: Sanofi
Principal Investigator:
Completion Date (primary or actual): May 2004
Obese Patients With Untreated Dyslipidemias
To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia
First Posted: January 24, 2002
Condition(s): Obesity, Dyslipidemia
Intervention(s): Rimonabant (SR141716)
Status: Completed
Enrollment (expected or actual): 1033
Allocation: Randomized
Sponsor: Sanofi
Principal Investigator:
Completion Date (primary or actual): November 2003
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia.
N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.
First Posted: February 26, 2015
Condition(s): Endometriosis, Chronic Pelvic Pain
Intervention(s): Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin
Status: Completed
Enrollment (expected or actual): 30
Allocation: N/A
Sponsor: University of Cagliari
Principal Investigator: Stefano Angioni, Associate Professor
Completion Date (primary or actual): August 2015
Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes
The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months.
The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months.
Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.
First Posted: September 18, 2008
Condition(s): Diabetes Mellitus, Type 2
Intervention(s): Rimonabant, Metformin, placebo
Status: Withdrawn
Enrollment (expected or actual): 0
Allocation: Randomized
Sponsor: Sanofi
Principal Investigator:
Completion Date (primary or actual): November 2008
Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes
The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.
Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.
First Posted: June 4, 2008
Condition(s): Diabetes Mellitus, Type 2
Intervention(s): Rimonabant, Placebo (for Rimonabant), Metformin
Status: Terminated
Enrollment (expected or actual): 403
Allocation: Randomized
Sponsor: Sanofi
Principal Investigator:
Completion Date (primary or actual): February 2009
Assessment of Needs of Moisturizers After Various Laser Treatments
Assessment of needs of moisturizers after various laser treatments
First Posted: December 5, 2012
Condition(s): Dermatologic Disorders, Injury Due to Laser
Intervention(s): Physiogel, Moisturizer
Status: Completed
Enrollment (expected or actual): 20
Allocation: N/A
Sponsor: Pusan National University Hospital
Principal Investigator:
Completion Date (primary or actual): April 2015
Palmitoylethanolamide for Post-operative Pain Prevention
Postsurgical pain becomes chronic when it lasts more then two months after surgery. A neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates after urologic and gynecologic surgeries.
Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors release, without adverse events.
The investigators assume that perioperative administration of PEA can reduce chronic postsurgical pain incidence of patients undergoing to urologic and gynecologic elective surgery.
First Posted: December 13, 2011
Condition(s): Chronic Post-operative Pain
Intervention(s): Palmitoylethanolamide, Placebo
Status: Not yet recruiting
Enrollment (expected or actual): 300
Allocation: Randomized
Sponsor: University of Modena and Reggio Emilia
Principal Investigator: Laura Rinaldi, Medical Doctor
Completion Date (primary or actual): July 2013
Antagonistic Interaction CB1-paracetamol
Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of Paracetamol in healthy volunteers
First Posted: September 10, 2008
Condition(s): Pain
Intervention(s): Rimonabant and Paracetamol and placebo
Status: Completed
Enrollment (expected or actual): 24
Allocation: Randomized
Sponsor: University Hospital, Clermont-Ferrand
Principal Investigator:
Completion Date (primary or actual): October 2008
Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.
First Posted: August 14, 2008
Condition(s): Atherosclerosis, Cardiovascular Diseases
Intervention(s): Simvastatin or Atorvastatin, Enalapril, Aspirin or clopidogrel, Rimonabant
Status: Recruiting
Enrollment (expected or actual): 2948
Allocation: Randomized
Sponsor: Hospital Arnau de Vilanova
Principal Investigator:
Completion Date (primary or actual): April 2009
Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque
The aim of the present study is to examine the atherosclerotic plaque stability using in vivo and in vitro techniques and to investigate the influence of exercise, anti-diabetic, lipid-lowering and cannabinoids receptor antagonists on atherosclerotic plaque texture in patients with cardiovascular risk and animals prone to atherosclerosis.
First Posted: March 14, 2008
Condition(s): Carotid Atherosclerosis, Stroke, Type 2 Diabetes, Metabolic Syndrome
Intervention(s): atorvastatin, rimonabant, rosiglitazone, metformin
Status: Completed
Enrollment (expected or actual): 300
Allocation: Randomized
Sponsor: Aristotle University Of Thessaloniki
Principal Investigator: Nikolaos Kadoglou, MD,PhD
Completion Date (primary or actual): December 2007
A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months.
The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.
First Posted: March 20, 2007
Condition(s): Diabetes Mellitus, Type 2
Intervention(s): Rimonabant, Glimepiride, Metformin
Status: Terminated
Enrollment (expected or actual): 508
Allocation: Randomized
Sponsor: Sanofi
Principal Investigator:
Completion Date (primary or actual): November 2008
China Cognition and Aging Study
The aim of this study is to establish and perfect the China Cognition and Aging Study (China COAST) cohort, to clarify the epidemiology, influencing factors, genetic characteristics, pathogenesis, disease characteristics and diagnosis and treatment status of dementia and its subtypes in China. It is of great significance to establish a relatively comprehensive national database of cognitive disorders, improve the clinical diagnosis and treatment level of cognitive disorders, and formulate prevention and treatment strategies for dementia. The primary aims of China COAST are as follows:
To use the prospective cohort to establish a large database research platform, so as to provide comprehensive epidemiological data, clinical and neuropsychological evaluation data, biological samples, and laboratory tests and imaging data.
To update the prevalence and incidence rate of dementia and its subtypes every 2-3 years, and clarify the conversion pattern from normal elderly to MCI and from MCI to dementia.
To explore the known or unknown protective and risk factors of dementia and its major subtypes (AD, VaD, other dementia).
To discover new pathogenic genes and susceptible genes of dementia and its major subtypes (AD and VaD), as well as new mutation sites of known pathogenic genes. To study the genetic variation, mutation and polymorphism of PSEN1, PSEN2, APP and APOE genes in dementia patients, and to understand their distribution and roles in the pathogenesis.
To study the biomarkers (body fluid, genetics, imaging) with diagnostic value of MCI, AD (sporadic and familial) and VaD, to define their cut-off values, and to establish prediction models.
To study the diagnostic criteria of cognitive normal, MCI, dementia and their subtypes (clinical and molecular subtypes) in the cohort, and to make psychological assessment scales with high sensitivity and specificity, and in line with the characteristics of Chinese people.
To find potentially modifiable risk factors for dementia and to study the prevention and intervention effect of non-pharmacological treatment on APOE ε4 carriers, MCI and AD or other dementia patients,which included improvements in education, nutrition, health care, and lifestyle changes. This needs a long time follow-up.
To explore the relationship between dementia as well as its major subtype AD and cerebral and systemetic circulatory disorders (for example, mixed dmentia), as well as potential therapeutic strategies.
To carry out investigation and researches about dementia related education, improve the awareness of dementia, and strengthen the management of dementia.
To investigate the level of stigma and discrimination and its influencing factors in patients with Alzheimer's disease and their caregivers.
First Posted: August 31, 2018
Condition(s): Mild Cognitive Impairment(MCI), Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD), Vascular Dementia (VaD), Normal Control, Non-Alzheimer Degenerative Dementia
Intervention(s):
Status: Recruiting
Enrollment (expected or actual): 100000
Allocation:
Sponsor: Capital Medical University
Principal Investigator: Jianping Jia, Chief Director
Completion Date (primary or actual): January 1, 2038
HIV Treatment Retention Interventions for Women Living With HIV (Siyaphambili Study)
The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among female sex workers (FSW) living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). Viral suppression is defined as a viral load assessment <50 RNA copies/mL. The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment.
First Posted: April 17, 2018
Condition(s): HIV-1 Virologic Response
Intervention(s): DTP, ICM
Status: Completed
Enrollment (expected or actual): 1391
Allocation: Randomized
Sponsor: Johns Hopkins Bloomberg School of Public Health
Principal Investigator:
Completion Date (primary or actual): November 24, 2021
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.
Healthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40 years of age may be eligible for this study.
We also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to AD.
Eligible participants undergo the following tests and procedures:
Medical family and medication history
Skin examination
Blood tests (research blood as well as serum IgE, and complete blood count)
Skin samples to analyze microbes. Samples are obtained by the following methods: swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal) of a small skin sample less than 1/4-inch (5 mm) in diameter.
Nose swabs to analyze microbes.
Patients with eczema may have photographs of their skin taken to help monitor the skin rashes.
Participants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and during all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible.
First Posted: January 31, 2008
Condition(s): Atopic Dermatitis, Eczema, Ichthyosis Vulgaris
Intervention(s):
Status: Recruiting
Enrollment (expected or actual): 530
Allocation:
Sponsor: National Human Genome Research Institute (NHGRI)
Principal Investigator:
Completion Date (primary or actual):
Dyskinesia in Parkinson's Disease (Study P04501)
The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added.
Approximately 160 participants will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, 40 new participants may be added, for a total of 200 participants. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.
First Posted: December 4, 2006
Condition(s): Parkinson Disease, Movement Disorders, Central Nervous System Diseases, Neurodegenerative Diseases, Brain Diseases
Intervention(s): Preladenant, Preladenant, Preladenant, Preladenant, Placebo, L-dopa, Other Parkinson's Disease treatments
Status: Completed
Enrollment (expected or actual): 253
Allocation: Randomized
Sponsor: Merck Sharp & Dohme LLC
Principal Investigator:
Completion Date (primary or actual): October 5, 2008
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