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125421. Liver Transplantation for Cholangiocarcinoma

System Stage I or II CCA are transferable to select patients with T3 or N1 disease. Specific Aim #2: To determine whether success achieved with the only published protocol currently in use is directly transferable to the University of Utah's liver transplant program. Liver Transplant Protocol: The surgical protocol will initially be offered to liver transplant candidates with de novo hilar CCA or CCA arising in the setting of PSC. Diagnosis of CCA will be established by intraluminal brush cytology (...) Procedure: Liver Transplantation Transplantation will initially be performed with deceased donor livers using the technique of caval-sparing hepatectomy unless suspected caudate involvement or caudate atrophy is a concern regarding the resection margin. Patients will be assigned a provisional Model for End-Stage Liver Disease (MELD) score by the United Network for Organ Sharing (UNOS) Regional Review Board that will make a recipient eligible for transplantation within three months at the time of listing

2008 Clinical Trials

125422. Exercise Intervention to Reduce Postural Instability in Osteoarthritis

as data on key mediating variables, including level of participation (dose of intervention), body mass index (BMI), analgesic use, tolerance of intervention, and number of joints affected by OA. Measurement tools: Balance is measured with Sensory Organization Test and Limits of Stability test using Neurocom Smart Balance Master and Berg Balance Test; Gait is measured with multiple kinetic and kinematic variables using VICON 3-D Motion Analysis System; OA symptoms/physical disability are measured using (...) with or without foot drop, as determined by medical record review and physical exam; Severe Peripheral Vascular Disease with claudication or Spinal Stenosis with pseudoclaudication/chronic low back pain; These impairments would further impair gait and balance, and would jeopardize safety during the intervention and/or confound the effect of the intervention. Lower extremity amputations, or foot deformities; Mobility limitations due to altered lower extremity skin integrity/ulcer, where weight-bearing would

2008 Clinical Trials

125423. Age-17 Follow-up of Home Visiting Intervention

Visits from nurses from mid-pregnancy to child age 2 years. Outcome Measures Go to Primary Outcome Measures : Maternal life-course (reflected in reduced total public benefit expenditures for SNAP, AFDC/TANF, and Medicaid). [ Time Frame: through first child age 18 ] Public benefit expenditures estimated from review of state administrative records and maternal report of all children's birth dates. Program effects on public-benefit expenditures hypothesized to be especially pronounced for mothers (...) , and self-reported antisocial behavior, especially for crimes involving interpersonal violence. [ Time Frame: at youth age 18 ] Self-reported involvement with criminal justice system and antisocial behavior. Program effects on arrests and convictions hypothesized to be greater for females. Youth risk for HIV infection, pregnancies, births, use of substances, and SUDs. [ Time Frame: at youth age 18. ] Outcomes based upon self-report and urine assays for STI's and substance use. Secondary Outcome Measures

2008 Clinical Trials

125424. Conatumumab/Panitumumab Combination Metastatic Colorectal Cancer Study

) Must have received 1, 2, or 3 prior chemotherapy regimens for Metastatic Colorectal Cancer Competent to comprehend, sign, and date the independent ethics committee/institutional review board (IEC/IRB) approved written informed consent Exclusion Criteria: History of other primary cancer, unless: Curatively resected non-melanomatous skin cancer Curatively treated cervical carcinoma in situ Other primary solid tumor curatively treated with no known active disease present and no treatment administered (...) for ≥ 5 years before enrollment Prior treatment with anti-epidermal growth factor receptor (EGFr) inhibitors (eg, cetuximab, erlotinib, gefitinib), unless treatment was received in the adjuvant setting ≥ 6 months before enrollment Use of systemic chemotherapy and radiotherapy ≤ 30 days before enrollment Use of prior anti-tumor therapies with a short serum half-life (less than 1 week) including prior experimental agents or approved anti-tumor small molecules ≤ 30 days before enrollment Use of anti

2008 Clinical Trials

125425. Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase

system dysfunction. Hunter Syndrome is a rare disease with an estimated incidence of 1 in 162,000 live births. Condition or disease Intervention/treatment Phase Hunter Syndrome Mucopolysaccharidosis II (MPS II) Biological: Idursulfase Phase 2 Phase 3 Detailed Description: Study TKT024EXT was conducted in 2 phases. The first phase ("Phase I") was 2 years (104 weeks) in duration and consisted of weekly infusions of IV idursulfase (0.5 mg/kg), and the collection of patients' safety and clinical outcomes (...) for Study: 5 Years and older (Child, Adult, Older Adult) Sexes Eligible for Study: Male Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patient must have completed the double-blind phase of Study TKT024, defined as completing the Week 53 final evaluations. Patient, patient's parent(s), or legally authorized representative must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form after all relevant aspects of the study

2008 Clinical Trials

125426. Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream

: Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) [ Time Frame: Baseline/screen, Week 48, Week 60 ] Response assessed 12 weeks after treatment. Late Clinical Response (LCR): HSIL present at week 48 but none at week 60, with two independent reviews in agreement that HSIL absent at week 60. Complete response (CR): No HSIL on histology or cytology at weeks 48 or 60 (caveat: if HSIL at week 60, blinded chart notes and photographs were reviewed by two clinicians, and decision (...) was reached by agreement or consensus whether HSIL had been missed at week 48. Cases that reviewers independently agreed had not been missed at week 48 were considered true recurrences) Partial Clinical Response (PCR): HSIL on cytology with no HSIL histology, or improvement >50% in the number of lesions with HSIL, or an improvement >50% in lesion size, area, or clinical characteristics (e.g. acetowhite staining, Lugol's staining, or vascular changes were improved) No Response (NR): HSIL present at weeks

2008 Clinical Trials

125427. Intervention Groups for Adolescents With Type 1 Diabetes Mellitus

for Adolescents With Type 1 Diabetes Mellitus 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. ClinicalTrials.gov Identifier: NCT00622271 Recruitment Status : Completed First Posted : February 25, 2008 Last Update Posted : November 17, 2011 Sponsor: Children's Hospital and Health System Foundation, Wisconsin Information provided by (Responsible (...) Party): Jessica C. Kichler, Children's Hospital and Health System Foundation, Wisconsin Study Details Study Description Go to Brief Summary: The purpose of this study is to utilize a group therapy adjustment and coping program at the Children's Hospital of Wisconsin with patients who have Type 1 Diabetes Mellitus (T1DM) and their parents within a "typical" clinical condition of patients who have been referred for outpatient therapy services. To extend the previous literature on these types of peer

2008 Clinical Trials

125428. Preventing Aggressive Behavior in Demented Patients

Description Go to Brief Summary: The purpose of this study is to develop and pilot test and non-pharmacological intervention designed to prevent the occurence of aggression in persons with dementia. Condition or disease Intervention/treatment Phase Dementia Aggression Behavioral: Preventing Aggressive Behavior in Demented Patients Phase 3 Detailed Description: An expert panel has met to review the investigators' prior work and literature to help create a non-pharmacological intervention designed (...) Party: Kunik, Mark - Principal Investigator, Department of Veterans Affairs ClinicalTrials.gov Identifier: Other Study ID Numbers: MIRECC003 First Posted: February 22, 2008 Last Update Posted: October 18, 2010 Last Verified: October 2010 Keywords provided by VA Office of Research and Development: Behavioral Research Dementia Aggression Additional relevant MeSH terms: Layout table for MeSH terms Dementia Aggression Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive

2008 Clinical Trials

125429. Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder

who will not use The University of Texas Southwestern Medical Center - Institutional Review Board (UTSW IRB) approved methods of birth control or abstinence during the study Treatment-resistant depressed persons defined as having failed two adequate trials of antidepressants Current antipsychotic or antidepressant therapy or psychotherapy Initiation of other psychotropic medications or psychotherapy within past 2 weeks (e.g., anxiolytics, hypnotics) Contacts and Locations Go to Information from (...) Verified: January 2014 Keywords provided by Sherwood Brown, University of Texas Southwestern Medical Center: Asthma Depression Escitalopram Additional relevant MeSH terms: Layout table for MeSH terms Disease Asthma Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Mood Disorders Mental

2008 Clinical Trials

125430. Pilot Safety and Efficacy Study of Isolagen Therapy in Treatment of Restrictive Burn Scars

baseline of all study assessments [ Time Frame: Day 0, 14, 30, 60, 90 and 120 ] Secondary Outcome Measures : Review of adverse Events, vital signs and physical examination [ Time Frame: Day 0, 14, 30, 60, 90 and 120 ] 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 (...) or in remission for a minimum of 6 months Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, or Ehlers Danlos syndrome Active systemic infection as shown by any one of the following: symptoms, fever and/or an elevated white count (subjects who present with an active systemic infection may be enrolled and biopsied after the infection has resolved) Requires chronic antibiotic or steroidal therapy Any

2008 Clinical Trials

125431. Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme

cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sorafenib may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving bevacizumab together with sorafenib works in treating patients with recurrent glioblastoma multiforme. Condition or disease Intervention/treatment Phase Brain and Central Nervous System (...) information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme as determined by pre-registration central pathology review Gliosarcoma allowed Must have evidence of tumor progression by MRI or CT scan following radiotherapy or the most recent anti-tumor therapy No more than 1 chemotherapy regimen for progressive or recurrent disease Bidimensionally

2008 Clinical Trials

125432. Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

participant-reported fatigue To evaluate the safety and tolerability of teriflunomide To evaluate the pharmacokinetics (PK) of teriflunomide Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes Condition or disease Intervention/treatment Phase Multiple Sclerosis Drug: Teriflunomide Drug: Placebo Phase 3 Detailed Description: The study (...) if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS

2008 Clinical Trials

125433. Predicting the Diagnosis of Asthma

often misinterpret the questions or fail to answer the question altogether. In this study, a physician will review the questionnaire with the patient in order to clarify each question. The goal in this study is to evaluate a simplified set of questions that can be easily implemented into clinical practice that will predict the presence or absence of asthma. Hypothesis A simplified questionnaire will predict asthma in adults. Study Objectives § Primary Objective o To evaluate the predictive value (...) , peptic ulcer, or renal disease, immunologic compromise, current malignancy, current or quiescent tuberculosis. Concomitant Medications: Beta blockers Systemic corticosteroids Angiotensin Converting Enzyme (ACE) inhibitors (Note: Immunotherapy for the treatment of allergies is allowed, provided that the subject has received a constant dose for 30 days prior to Visit 0, and that the same dose will continue throughout the study.) Contacts and Locations Go to Information from the National Library

2008 Clinical Trials

125434. Prevalence+Significance of Paraneoplastic Autoantibodies in Many Cancers

Kettering Cancer Center Study Details Study Description Go to Brief Summary: You may have a type of cancer associated with "antineuronal antibodies" in your blood. Antibodies are substances made by the immune system. They are used by the body to fight infections and other diseases. Antineuronal antibodies are antibodies that react with nerve cells but they also react with some tumors. We believe that the immune system makes these antibodies to fight the cancer. In some patients with these antibodies (...) or recurrent SCLC, or mixed small cell/non small cell lung cancer, or neuroblastoma, or ovarian or breast cancer, or Hodgkin's disease in all cases confirmed by pathological review. Criteria Inclusion Criteria: Patients with previous cancers or concurrent cancers. Patient has or may have, newly-diagnosed or recurrent SCLC, or mixed small cell/non small cell lung cancer, or neuroblastoma, or ovarian or breast cancer, or Hodgkin's disease in all cases confirmed by pathological review. Exclusion Criteria

2008 Clinical Trials

125435. Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data. Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement. URL (...) : https://www.clinicalstudydatarequest.com/ Keywords provided by Astellas Pharma Inc: Antifungal Micafungin Echinocandin Candidiasis Additional relevant MeSH terms: Layout table for MeSH terms Candidiasis Candidemia Candidiasis, Invasive Mycoses Fungemia Sepsis Infection Invasive Fungal Infections Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Micafungin Antifungal Agents Anti-Infective Agents

2008 Clinical Trials

125436. Effect of Amount and Type of Dietary Carbohydrates on Risk for Cardiovascular Heart Disease and Diabetes

of their food, snacks, and calorie-containing beverages. Participants will also complete a daily food diary, symptoms questionnaire, medical and social history, and daily weigh-in. After meeting with a dietician to review progress, eligible participants will be randomly assigned to one of eight sequences of the four diet plans. Participants will follow each of the four diet plans for 5 weeks, with a period of at least 2 weeks separating each plan. During each dieting period, participants will be provided (...) or treatment in the 2 years prior to study entry (note: people with non-melanoma skin cancer, localized breast cancer, or localized prostate cancer can enroll if they did not require systemic chemotherapy) Active inflammatory bowel disease, malabsorption, or major gastrointestinal resection Renal insufficiency as determined by a serum creatinine greater than 1.2 mg/dL for women or greater than 1.4 mg/dL for men (these participants can enroll if their estimated glomerular filtration rate is greater than 40

2008 Clinical Trials

125437. A Study of Ispinesib in Metastatic Breast Cancer

review. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 100 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase I/II Non-Randomized, Open-Label, Dose-Finding Study of Ispinesib (SB-715992) Followed By a Fixed-Dose Study in Chemotherapy-Naïve Patients With Metastatic Breast Cancer (MBC). Study Start Date : December 2007 (...) or geographical conditions that do not permit compliance with the study protocol. Evidence of central nervous system (CNS) metastases or leptomeningeal disease Evidence of any other malignancy Previous exposure to any Investigational Agent Radiation therapy within 28 days, or within 3 months if BUN is ≥20mg/dl 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

2008 Clinical Trials

125438. T-Lymphocytes in Treating Patients With Epstein-Barr Virus-Positive Nasopharyngeal Cancer, NPC

: Baylor College of Medicine Collaborators: Texas Children's Hospital The Methodist Hospital System Center for Cell and Gene Therapy, Baylor College of Medicine Information provided by (Responsible Party): Helen Heslop, Baylor College of Medicine Study Details Study Description Go to Brief Summary: Patients have a type of cancer called nasopharyngeal cancer. This cancer has come back or not gone away or is at high risk for coming back after treatment (including the best treatment we know (...) for nasopharyngeal cancer). We are asking patients to volunteer to be in a research study using special immune system cells called EBV-specific cytotoxic T lymphocytes, a new experimental therapy. Most patients with nasopharyngeal cancer show evidence of infection with the virus that causes infectious mononucleosis, Epstein Barr virus (EBV), before or at the time of their diagnosis of nasopharyngeal cancer. EBV is found in the cancer cells of most patients with nasopharyngeal cancer, suggesting that it may play

2008 Clinical Trials

125439. Early Versus Delayed Enteral Feeding and Omega-3 Fatty Acid/Antioxidant Supplementation for Treating People With Acute Lung Injury or Acute Respiratory Distress Syndrome (The EDEN-Omega Study)

days (VFD) [ Time Frame: Measured at Day 28 ] Mortality before hospital discharge, with unassisted breathing [ Time Frame: Measured at Days 60 and 90 ] Secondary Outcome Measures : Number of intensive care unit-free days [ Time Frame: Measured at Day 28 ] Number of organ failure-free days (liver, kidney, heart, central nervous system, and hematologic) [ Time Frame: Measured at Day 28 ] Incidence of ventilator-associated pneumonia [ Time Frame: Measured at Day 28 ] Number of days from first meeting (...) Center More Information Go to Additional Information: Study Data/Documents: Identifier: ARDSNet-Omega NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Layout table for additonal information Responsible Party: National Heart, Lung, and Blood Institute

2008 Clinical Trials

125440. FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy

and willing to provide written informed consent willing to provide a brief review of medical history 18-70 yrs of age, of either gender Exclusion Criteria: less than 18, greater than 70 yrs of age any history of liver, renal, lung, hematological or coronary artery disease any history of active alcohol or drug abuse any previous diagnosis of HBV, HCV, HDV or HIV Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact (...) Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents

2008 Clinical Trials

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