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99301. Influence of Corn Farming on the Immune System

myeloma, leukemia). Factors that contribute to this excess risk have not been discerned. While several epidemiologic studies have observed an increased risk of NHL among farmers who are exposed to certain pesticides (i.e., phenoxyacetic acids, organophosphates, organochlorines, and triazines), these studies have not been conclusive. In addition, a clear mechanistic association between farming or pesticide exposure and subsequent development of cancer has not been identified. Given (...) that immunocompromised individuals are at increased risk for NHL, it has been hypothesized that altered immune function may be an indicator of increased potential for the development of immunologically based diseases such as NHL. Therefore, research into early immunologic effects of farming exposures holds some promise in discerning disease mechanisms and in identifying specific etiologic agents for lymphatic cancers such as NHL. Few such studies have been conducted. This protocol outlines a study of immune effects

2006 Clinical Trials

99302. Study of Markers of Cosmic Radiation Exposure and Effect Among Flight Crews

radiation exposure based on flight histories, i.e., those with long duration flying international routes, and a comparison group of university faculty with minimal flying history. These measurements will be used to determine if pilots have elevated frequencies of CA (specifically stable translocations) as compared with the university faculty. In addition, the frequencies of CA will be examined in relation to the cumulative cosmic radiation dose to determine if there is a dose-response relationship (...) and so we plan to adjust for them in the statistical analyses. Pilots will be identified based on the Allied Pilots Association roster and faculty from a commercial company that maintains a database of university faculty, including those in the Chicago area. Potential participants will be notified of the study by mail and recruited/screened for eligibility over the telephone. We will compensate participants $100 for their time. A field station will be set up at a medical or health clinic convenient

2006 Clinical Trials

99303. Diet and Genetic Damage

are measured. Condition or disease Diet Detailed Description: Colorectal cancer is one of the most common forms of cancer worldwide and is the second leading cause of cancer death in the United States. Given the frequency of occurrence and the poor prognosis for many afflicted individuals, prevention of this disease has been a major public health priority for the past few decades. However evidence from epidemiological studies has yet to explain the tremendous excess risk in developed countries, a trend (...) , respectively. However, not all studies of heterocyclic amines in humans have shown a positive association with colorectal cancer risk, and clear consensus regarding this association is lacking. Based on the implications from these epidemiological studies, researchers at NCI have recently conducted a series of controlled feeding studies aimed at relating short-term exposure to heterocyclic amines through fried meat consumption to transient changes in urine mutagenicity levels. These studies provide evidence

2006 Clinical Trials

99304. Environmental Factors in the Development of Polycystic Ovary Syndrome

for this study will come from the Mid-Atlantic Twin Registry (MATR). Many (3283) potential participants have already been identified based on their answers to a preliminary MATR screening questionnaire. Out of the approximately 7145 twin women of reproductive age who completed these MATR screening questionnaires, 1803 women reported irregular periods, 954 reported ovarian cysts, and 526 reported both irregular periods and ovarian cysts. Many of the women in this last group are likely to have PCOS (...) consists of a telephone survey of the 3282 women with irregular periods and/or ovarian cysts. The survey will be conducted by the MATR. The instrument to be used contains a series of simple and direct questions and will take about 10 minutes to complete. The questions were designed to identify PCOS and their content deals with the frequency of menstrual periods (six or fewer per year being a major diagnostic criterion), a previous diagnosis of PCOS, obesity, excess facial hair and other evidence

2006 Clinical Trials

99305. Bio-Behavioral Lung Cancer Prevention Program

of medication (week 3 of treatment). All subjects will also receive a 7-week group behavioral smoking cessation treatment (over an 11 week period). This study may yield information that will help clinicians identify the most effective smoking cessation treatment for a particular patient, based on his/her background. Condition or disease Intervention/treatment Phase Smoking Cessation Drug: zyban Phase 4 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial (...) with bulimia or anorexia nervosa, diabetes treated with oral hypoglycemics or insulin, excessive use of alcohol or alcoholism, current addiction to opiates, cocaine, or stimulants, use of other drugs containing bupropion (e.g., Wellbutrin, Wellbutrin SR), allergy to bupropion, currently taking particular medications (e.g., monoamine oxidase inhibitor, antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants and anorectics), recently taken a MAOI (less than 14 days

2006 Clinical Trials

99306. Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

Posted : March 6, 2015 Sponsor: Palo Alto Veterans Institute for Research Collaborator: Hoffmann-La Roche Information provided by: Palo Alto Veterans Institute for Research Study Details Study Description Go to Brief Summary: The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in patients who are obese. However, it is not clear whether this is related to suboptimal dosing of the medication or alterated response in obese patients. Alterated immune response had (...) ) with chronic Hepatitis C Chronic Hepatitis C infection with documented HCV RNA Body habitat either as obese or non-obese as defined above Currently not under IFN therapy Non-African American Exclusion Criteria: Body habitat neither obese or non-obese as defined for the purpose of this study Unable to give consent On immunomodulatory agents such as prednisone Active infection other than Hepatitis C Co-infection with HBV or HIV Active or excessive alcohol use Other cause of chronic Hepatitis Contacts

2006 Clinical Trials

99307. Expanded Breast Cancer Registry and Tissue Repository

) from patients diagnosed with breast cancer who consent to providing excess/extra tissue and additional blood for the Tissue Repository. This tissue bank will serve as a repository from which researchers can access tissue samples to conduct laboratory-based studies of genetic determinants of breast cancer risks, prognosis and survival in women with breast cancer seen in this institution. Study Design Go to Layout table for study information Study Type : Observational [Patient Registry] Estimated

2006 Clinical Trials

99308. Cognitive Behavioral Therapy Plus Motivational Interviewing for Treatment of Obsessive-Compulsive Disorder

; fears of contamination and illness; fears of making mistakes; intrusive distressing sexual or religious imagery; and fears of losing things. In an effort to relieve anxiety about these obsessions, people with OCD develop repetitive behaviors called compulsions. Some examples of compulsions include the following: repetitive washing and cleaning; excessive checking; excessive ordering and arranging; and extreme hoarding and saving. These thoughts and behaviors interfere with everyday life to a great (...) for the duration of the EX/RP+MI treatment. Able to provide informed consent No prior adequate EX/RP treatment (defined as at least 8 exposure sessions that include response prevention instructions and between sessions assignments in a 2 month period) Based on hx, subject is unlikely to require a change in med during the course of EX/RP/EX/RP+MI treatment Exclusion Criteria: Any additional medical or psychiatric conditions that could make participation in the study medically inadvisable Currently receiving

2006 Clinical Trials

99309. Acupuncture for the Treatment of Posttraumatic Stress Among Military Personnel

measures PTSD and ASD symptoms (based on the DSM-IV symptom criteria) related to up to three traumatic events. Higher scores indicate more intense and more frequent symptoms of PTSD, while lower scores represent the absence of or less intense, less frequent symptoms of PTSD. The CAPS was used in this study as the primary diagnostic tool for PTSD at entry into the study and at the three-month follow-up, and will help validate scores on the PCL. The Trauma History Questionnaire [ Time Frame: baseline, 3 (...) , 3 months ] The AUDIT was developed by the World Health Organization to identify hazardous and harmful alcohol use in adults and to serve as a brief (10-item) screening instrument for excessive drinking. It was intended to identify a broad spectrum of problem drinkers and distinguish them from both hospitalized alcoholics and from normal drinkers. The instrument was modified for our purposes to inquire about participants' behavior since returning from deployment. It was used to evaluate

2006 Clinical Trials

99310. BURULICO Drug Trial Study Protocol: RCT SR8/SR4+CR4, GHANA

Study Description Go to Brief Summary: The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. This preliminary advice was based on observations in 21 patients with pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time. In patients treated with SR for at least 4 weeks, M. ulcerans could no longer be cultured from (...) . In endemic regions in Ghana, patients will be actively recruited and followed if ≥ 5 years of age, and with early (i.e., onset < 6 months) BUD. consent by patients and / or care givers / legal representatives clinical evaluation, and by analysis of three 0.3 cm punch biopsies under local anaesthesia. disease confirmation: dry reagent-based polymerase chain reaction (DRB-PCR IS2404) randomization: either SR for 8 weeks, or 4 weeks of SR followed by R and clarithromycin (C) stratification: ulcerative

2006 Clinical Trials

99311. A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

ChimeriVax™-JE or JE-VAX® Vaccine. [ Time Frame: Day 0 (Pre-vaccination) and up to Month 12 After First Dose ] Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seropositive status for the ChimeriVax™-JE group was based on the ChimeriVax™-JE virus strain and positive status for the JE-VAX® group was based on the Nakayama virus strain. Participants were defined (...) Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen. Pregnancy. Excessive alcohol consumption, drug abuse. Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its

2006 Clinical Trials

99312. Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

patients will receive G-CSF 5 mcg/kg/day intravenously(IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days. Other Name: G-CSF Drug: cyclophosphamide Cyclophosphamide to be administered with high volume fluid flush and mesna (MT(S) 9006) at 10:00am, or per institutional routine, on days-7 and -6 after (...) fludarabine. Cyclophosphamide 60mg/kg/day intravenous (IV) x 2 days, total dose 120 mg/kg (days -7 and -6) Dosing is calculated based on Actual BodyWeight (ABW) unless ABW > 30 kg above Ideal BodyWeight (IBW), in which case the dose should be computed using adjusted body weight. Other Name: Cytoxan Drug: cyclosporine Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of > 200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12

2006 Clinical Trials

99313. Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids)

(NICHD) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: Uterine leiomyomas (fibroids) represent a major public health problem with few effective therapies. Currently, the only definitive treatment is hysterectomy and women are demanding alternative therapies to surgery. We have developed a new approach to the treatment of uterine fibroids based on collaborative laboratory research into the molecular, ultra-structural (...) , and histopathologic changes that occur with the transformation of normal uterine myocytes into abnormal myocytes comprising uterine fibroids. We have confirmed that excessive, dysregulated collagen production (fibrosis) and abnormal collagen deposition is an underlying etiology in the pathogenesis of leiomyoma. We will test the hypothesis that an anti-tumor drug (Pirfenidone) will decrease the size of clinically relevant leiomyomas by 30%. The specific aim is to compare the effects of pirfenidone with placebo

2006 Clinical Trials

99314. Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents

the following behaviors: increased energy, activity, and restlessness; excessively "high," overly good, euphoric mood; and extreme irritability. In contrast, a depressive episode is characterized by a lasting sad, anxious, or empty mood; feelings of hopelessness or pessimism; and decreased energy. Adolescents with bipolar disorder have high rates of disease recurrence, suicide attempts, functional impairment, and mental health service utilization, even with aggressive treatment with mood stabilizers (...) continuous weeks) Meets Diagnostic and Statistical Manual of Mental Disorders, IV criteria for substance abuse disorder or substance dependence disorder within 3 months of study entry (based on the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version ) Meets current criteria for bipolar, not otherwise specified, or substance-induced mood disorder Diagnosis of mental retardation, autism, or organic central nervous system disorder Severe, unremitting psychosis

2006 Clinical Trials

99315. Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal

Eligible for Study: All Accepts Healthy Volunteers: No Criteria INCLUSION CRITERIA Males and females aged 18 to 50 years Evidence of need for third molar extraction as determined by medical and dental history, as well as clinical and radiographic evaluation Willing to provide at least one wisdom tooth for research purposes Willing to provide one or more of the following tissue types for research purposes: Excessive gingival tissue around extraction sockets Oral tissues from the floor of the mouth (...) to be unusually difficult based on panoramic radiograph. Indicators of unusual difficulty include increased depth of tooth impaction, extreme angulation of a tooth, and close proximity of a tooth to the inferior alveolar nerve canal and/or maxillary sinus. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its

2006 Clinical Trials

99316. Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

studies before adding more. Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. Identifier: NCT00317434 Recruitment Status : Terminated (Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited (...) the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 19 Years to 90 Years (Adult, Older Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Histologic diagnosis of epithelial ovarian or primary peritoneal cancer Measurable disease or evaluable disease with CA125 >100 One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum

2006 Clinical Trials

99317. SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

Endpoint of All Deaths, All MI, All Revascularizations (DMR) [ Time Frame: 2 years ] Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR) [ Time Frame: 3 years ] Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition [ Time Frame: 0-30 days ] ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter (...) has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post * Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization. Definite + Probable Stent Thrombosis Rate Based on ARC Definition [ Time Frame: 31-393 days ] ARC: Academic Research

2006 Clinical Trials

99318. A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1

Pharmaceuticals, Inc. Study Details Study Description Go to Brief Summary: This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy. Condition or disease Intervention/treatment Phase (...) Completion Date : April 2008 Actual Study Completion Date : November 2008 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1 Drug: MKC-1 Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle Outcome Measures Go to Primary Outcome Measures : Antitumor activity, based on the objective response rate [ Time Frame: every 8 weeks ] Eligibility

2006 Clinical Trials

99319. Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Secondary Outcome Measures : Number of Participants With Recurrent Symptomatic VTE and All Deaths [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ] VTE or any death which occured from randomisation to end (...) of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Number of Participants With Recurrent Symptomatic DVT [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ] Symptomatic DVT which

2006 Clinical Trials

99320. Pilot Study of the Utility of Empiric Antibiotic Therapy for Suspected ICU-Acquired Infection

: Canadian Critical Care Trials Group Collaborator: The Physicians' Services Incorporated Foundation Information provided by: Canadian Critical Care Trials Group Study Details Study Description Go to Brief Summary: Infection developing in the intensive care unit is a common complication of critical illness, but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests usually is not possible for at least two days. It is unclear what the optimal management approach should (...) clinical outcome. We undertook a randomized pilot study to address the question: "In a critically ill patient for whom clinicians are uncertain whether infection may be present, and in whom potential sites of infection have been managed by removing or changing invasive devices, can a policy of delaying antibiotic treatment until cultures are available reduce the risks of excessive antibiotic use, without increasing the risks associated with delayed therapy?" Recognizing that the question has not been

2007 Clinical Trials

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