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Defensive Medicine

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4981. Adolescent Blood Pressure Variation and Ventricular Mass

to exacerbate pathophysiology. Essential hypertension risk might be reduced by modifying working and living environments and by training young persons at risk to cope with or avoid stressors that elicit defensive over-responding. DESIGN NARRATIVE: This longitudinal study tested two different models of sympathetic nervous system influence on the early pathophysiology of essential hypertension. The first neurogenic model was evaluated by determining whether an excessively variable or reactive blood pressure (...) months. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record. Study Design Go to Layout table for study information Study Type : Observational Study Start Date : July 1987 Actual Study Completion Date : June 1991 Resource links provided by the National Library of Medicine related topics: Groups and Cohorts Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library

2000 Clinical Trials

4982. Dose Estimation for Studies of Acute Respiratory Effects

by the respiratory defense system appear to represent one end of the continuum toward progressive, chronic and potentially disabling physiologic changes. Repeatable epidemiologic studies of dose-response relationships necessitate accurate measures of 'dose'. However, in occupational and environmental settings, exposure to a toxin is seldom found at identical concentrations and/or particle sizes among persons with the same activity patterns. In addition, air concentration does not account for factors (...) was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record. Study Design Go to Layout table for study information Study Type : Observational Study Start Date : September 1992 Actual Study Completion Date : August 1995 Groups and Cohorts Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends

2000 Clinical Trials

4983. Effectiveness of Adding Remune to Your Current Anti-HIV Drug Combination

by "boosting" the body's immune cell defense against the HIV virus before the virus enters cells. It also blocks the virus from entering the cells. This study will see whether Remune will improve the immune cell natural defense in patients who are also taking anti-HIV drugs. Condition or disease Intervention/treatment Phase HIV Infections Biological: HIV-1 Immunogen Phase 1 Detailed Description: During primary HIV infection, after an initial burst in viral load, the body mounts an immunologic response (...) Type : Interventional (Clinical Trial) Enrollment : 45 participants Masking: Double Primary Purpose: Treatment Official Title: A Multicenter, Double-Blind, Phase I, Adjuvant Controlled Study to Evaluate the Effect of Remune (HIV-1 Immunogen) Compared to IFA, in Combination With Fully Suppressive Antiviral Drug Therapy on HIV-1-Specific Immunogenicity in Subjects With Acute or Primary HIV-1 Infection Resource links provided by the National Library of Medicine related topics: Arms and Interventions

2000 Clinical Trials

4984. Natural History of Rheumatic Diseases in Minority Communities

, muscles, tendons or ligaments. Some cause abnormalities of the immune system the body s defense against disease. Some rheumatic diseases are painful or deforming and some can be life threatening. Information obtained from this study will be used to learn about the disparities in rheumatic disease in the minority community and to design further, more targeted, research studies to address this issue. Patients with known or suspected rheumatic disease 18 years of age or older may be eligible (...) in the rheumatic diseases. Study Design Go to Layout table for study information Study Type : Observational Estimated Enrollment : 100000 participants Observational Model: Cohort Time Perspective: Prospective Official Title: Studies of the Natural History of Rheumatic Disease in Minority Communities Study Start Date : September 12, 2001 Resource links provided by the National Library of Medicine related topics: Groups and Cohorts Go to Outcome Measures Go to Primary Outcome Measures : To generate hypotheses

2001 Clinical Trials

4985. The Effects of Upper Airway and Digestive Tract Tumors on the Immune System

(NIDCD) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: The goal of this study is to learn how tumors of the upper airway and digestive passages (tongue, throat, mouth, and voicebox) affect the body's immune defenses and energy storage. Previous studies have shown that tumors of the vocal tract produce signals that could help the tumor escape the body's immune defenses and use the body's energy and mineral stores to grow (...) of the Upper Aerodigestive Tract Study Start Date : December 1996 Study Completion Date : December 2004 Resource links provided by the National Library of Medicine resources: Groups and Cohorts Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may

1999 Clinical Trials

4986. Collection of Blood and Bone Marrow From Healthy Volunteers and Patients for Research Purposes

Study Population Normal Volunteers and patients Criteria INCLUSION CRITERIA: Healthy volunteers age greater than or equal to 18 years. Subjects with hematologic disease age greater than or equal to 2 (for subjects less than 18, blood and bone marrow specimens will be obtained concurrently with clinically indicated sampling). EXCLUSION CRITERIA: History of a significant bleeding disorder. Abnormal host-defense mechanisms. Contacts and Locations Go to Information from the National Library of Medicine (...) Volunteers and Patients for Research Purposes Study Start Date : June 5, 1997 Groups and Cohorts Go to Group/Cohort Group 1 Normal Volunteers and patients. Outcome Measures Go to Primary Outcome Measures : To provide a readily available supply of samples for blood and bone marrow for in vitro studies in the Hematology Branch laboratories [ Time Frame: Ongoing ] The collection of adequate cells for laboratory research. Eligibility Criteria Go to Information from the National Library of Medicine Choosing

1999 Clinical Trials

4987. Comparing Therapies for the Treatment of Severe Aplastic Anemia

): National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Study Details Study Description Go to Brief Summary: Severe Aplastic Anemia (SAA) is a rare and very serious blood disorder in which the bone marrow stops producing the cells which make up blood; red blood cells, white blood cells, and platelets. Researchers believe this is caused by an autoimmune reaction, a condition in which the natural defense system of the body begins attacking itself. In SAA (...) Date : September 30, 2002 Actual Study Completion Date : March 3, 2008 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: A D1-4 cyclophosphamide 50 mg/kg IV, then cyclosporine starting on d14 at 12 mg/kg/d for 6 months Drug: cyclophosphamide cyclophosphamide Drug: cyclosporine cyclosporine Experimental: B ATG at 40 mg/kg/d for 4 days then cyclosporine at 12 mg /kg/d for 6 months

1999 Clinical Trials

4988. Evaluation and Follow-up of Patients With Cryptococcosis

and immunologic testing will be performed on all subjects (patients, relatives, and healthy volunteers) to evaluate for possible immunogenetic factors that lead to susceptibility to cryptococcosis. Among the aims of this protocol are to better understand the pathophysiology and genetic factors that lead to defects in host defense and to use modern and evolving methods in molecular and cellular biology to elucidate the pathogenesis of this particular susceptibility. A better understanding of the underlying (...) of Medicine resources: Groups and Cohorts Go to Outcome Measures Go to Primary Outcome Measures : Fungal Clearance [ Time Frame: 0, 2 weeks, 1m, 3, 6, and 12 months following the end of amphotericin B induction therapy ] Neurologic sequalae [ Time Frame: 0, 2 weeks, 1m, 3, 6, and 12 months following the end of amphotericin B induction therapy ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your

1999 Clinical Trials

4989. Assessment of Patients With Multiple Sclerosis (MS)

) Study Details Study Description Go to Brief Summary: Multiple sclerosis (MS) is a disease of the nervous system. The exact cause of MS is unknown, but it is believed to be an autoimmune condition. Autoimmune conditions are diseases that cause the body's immune system and natural defenses to attack healthy cells. In the case of MS, the immune system begins attacking myelin, the cells that make up the sheath covering nerves. Without myelin, nerves are unable to transmit signals effectively (...) is not clear for the initial evaluation. Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 1388 participants Official Title: Combined Clinical, Immunological and Virological Assessment of Patients With Multiple Sclerosis (MS) Study Start Date : January 23, 1976 Study Completion Date : February 1, 2010 Resource links provided by the National Library of Medicine related topics: related topics: resources: Groups and Cohorts Go to Outcome Measures Go

1999 Clinical Trials

4990. Gene Therapy for Chronic Granulomatous Diseases

of increased host defense against an ongoing or potential infection. The clinical status of patients will be monitored for any evidence of toxicity. Information obtained from this study will provide information important for achieving the ultimate goal of the development of gene therapy for CGD that will be a permanent cure for this disorder. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 14 participants Primary Purpose: Treatment (...) Official Title: Gene Therapy Approach for Chronic Granulomatous Disease Study Start Date : June 1, 1995 Actual Primary Completion Date : December 13, 2010 Actual Study Completion Date : December 13, 2010 Resource links provided by the National Library of Medicine related topics: related topics: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision

1999 Clinical Trials

4991. The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine

if treatment with IFN-G can strengthen the ability of AIDS patients to control infections. This study will also determine how long after a single injection of IFN-G white blood cells remain stimulated. AIDS is a disease that progressively destroys that aspect of the body's defense called the immune system. It is particularly harmful to a class of cells called helper T-lymphocytes. The specific opportunistic infections and malignancies associated with AIDS have been treated with therapies that are often (...) to find the dose by which IFN-G works best. Condition or disease Intervention/treatment Phase HIV Infections Drug: Zidovudine Drug: Interferon gamma-1b Phase 1 Detailed Description: AIDS is a disease that progressively destroys that aspect of the body's defense called the immune system. It is particularly harmful to a class of cells called helper T-lymphocytes. The specific opportunistic infections and malignancies associated with AIDS have been treated with therapies that are often poorly tolerated

1999 Clinical Trials

4992. Genetic Analysis of Immune Disorders

) ( National Institute of Allergy and Infectious Diseases (NIAID) ) Study Details Study Description Go to Brief Summary: The purposes of this study are to 1) identify the genes responsible for certain immune disorders, 2) learn about the medical problems they cause, and 3) learn how to predict who is likely to develop these disorders and what the risk is of passing them on to children. The immune system is the body s defense system. Some immune deficiencies impair a person s ability to fight infections (...) about the immune system and what causes immune deficiencies. Participants may also learn the underlying cause of an immune disorder that affects them or someone in their family information may be useful in guiding treatment and in making decisions regarding family planning. Condition or disease DOK 8 STAT1 GATA2 Immunodeficiency STAT3 Detailed Description: This protocol includes studies of genetic defects of the immune system that cause failure of host defenses against infections, immune

1999 Clinical Trials

4993. Exogenous Toxicants and Genetic Susceptibility in ALS

mechanisms available within the Kaiser system. The patients with ALS will be compared to a sample of 350 age- and gender-matched persons without ALS from the same membership. Specific study aims are as follows: (1) to investigate the association of ALS with exposure to neurotoxicants including lead, other heavy metals, solvents and pesticides; (2) to determine whether inadequate oxidative defenses for protecting against free-radicals enhance the toxicity of exogenous exposures; (3) to examine (...) : August 2002 Resource links provided by the National Library of Medicine related topics: related topics: resources: Groups and Cohorts Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts

2001 Clinical Trials

4994. Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children

that are improved with rIFN-gamma. SECONDARY: To determine whether a change in CD4 cell count occurs and to assess virologic status and effects on AZT and ddI pharmacokinetics. It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection (...) . Condition or disease Intervention/treatment Phase HIV Infections Drug: Interferon gamma-1b Phase 1 Detailed Description: It is likely that infants and children severely immunocompromised by HIV infection would respond to immunomodulators that augment different portions of the host defense system. Interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with HIV infection. Patients are treated with subcutaneous rIFN-gamma 3

1999 Clinical Trials

4995. Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease

Title: A Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA Actual Study Completion Date : October 1998 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from (...) the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers

1999 Clinical Trials

4996. The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

: March 16, 2012 Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID) Study Details Study Description Go to Brief Summary: To determine the safety and usefulness of zidovudine (AZT) for the treatment of patients with early symptomatic HIV infection or early AIDS related complex (ARC). The ability of AZT to suppress HIV, to improve body defenses, and to prevent the occurrence (...) Official Title: The Safety and Efficacy of Zidovudine in the Treatment of Patients With Early AIDS Related Complex Actual Study Completion Date : February 1995 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about

1999 Clinical Trials

4997. Extracorporeal Support for Respiratory Insufficiency (ECMO)

of interstitial edema, the defenses of the lung against agents causing ARI, and the ultrastructural pathology and natural history of the disease were virtually unknown. The Task Force indicated a need for Respiratory Care Centers with highly trained personnel that could reduce mortality from ARI. This clinical trial grew out of the Task Force report. Nine participating centers defined ARI in clinical and physiological terms and agreed to a prospective randomized study for 3 years to compare treatment (...) . Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Allocation: Randomized Primary Purpose: Treatment Study Start Date : June 1974 Actual Study Completion Date : November 1979 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal

1999 Clinical Trials

4998. Effects of Endotoxin in Normal Human Volunteers

Go to Brief Summary: Bacterial infections can progress to a life-threatening illness called septic shock, characterized by low blood pressure and vital organ damage. The syndrome is thought to be caused by parts of the bacteria and by the body s own immune response to the infection. A major bacterial product that interacts with the immune defenses is called endotoxin. This study will examine the body s response to endotoxin in the lungs or bloodstream. When endotoxin is given in small amounts (...) : Treatment Official Title: The Cardiopulmonary Effects of Endotoxin in Normal Human Volunteers Study Start Date : April 6, 1992 Actual Primary Completion Date : March 21, 2007 Actual Study Completion Date : May 17, 2018 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your

1999 Clinical Trials

4999. Inflammatory Responses in Normal Volunteers and Patients With Abnormal Immune Responses

the Suction Blister Technique Study Start Date : April 24, 1990 Groups and Cohorts Go to Outcome Measures Go to Primary Outcome Measures : To identify mediators that contribute to the inflammatory process and granuloma formation by comparing mediators collected from healthy volunteers to patients with abnormal regulation of inflammation and patients with host defense defects. [ Time Frame: Ongoing ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate (...) inflammatory response that results in poor healing of recurrent infections. This study will measure and compare amounts of inflammatory mediators (chemicals involved in the inflammatory response) in healthy normal volunteers and in patients with abnormal immune responses. Healthy normal volunteers and patients with host defense defects or excessive inflammation, as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65 years of age. Participants will have eight small

1999 Clinical Trials

5000. A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma

than 40 percent of the patients showed shrinkage of their tumors, and some showed evidence for suppression of HIV growth in the body. However, the combination of IFN-A2b with AZT often caused a marked lowering of the white blood cell (WBC) count, especially a type of WBC called the granulocyte (or neutrophil) which is important in the body's defense against infection. Recombinant human GM-CSF is a human protein which is produced in bacteria. It has been shown to cause an increase in the WBC count (...) a type of WBC called the granulocyte (or neutrophil) which is important in the body's defense against infection. Recombinant human GM-CSF is a human protein which is produced in bacteria. It has been shown to cause an increase in the WBC count. AMENDED: 900910 to allow one patient to be treated beyond one year. Original design: GM-CSF, IFN-A2b, and AZT are given every day for 8 weeks. There are 6 patients per dose level. IFN-A2b and GM-CSF are given in two separate injections under the skin

1999 Clinical Trials

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