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125361. PK, Dose Proportionality, Food Effect And Repeat Dose Study Of Rosiglitazone XR In Healthy Volunteers

be reviewed with the medical monitor prior to enrolment. History of surgical procedures that might affect the absorption of rosiglitazone (e.g., partial/total gastrectomy, cholecystectomy) or any hepatic or biliary abnormalities such as Gilbert's syndrome. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 150mls of wine or 360mls of beer or 45mls of hard liquor) within 6 months of screening. Subject smoking more than 10 cigarettes per day (...) Verified: July 2017 Keywords provided by GlaxoSmithKline: Rosiglitazone XR Pharmacokinetics Strength Equivalence. Alzheimers Disease Repeat dose Dose proportionality Additional relevant MeSH terms: Layout table for MeSH terms Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs

2008 Clinical Trials

125362. Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

will be estimated using the method of Kaplan and Meier. Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events [ Time Frame: Up to 4 years postoperative chemotherapy treatment ] The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. These patterns will be summarized with descriptive statistics. The number of patients reporting (...) Additional relevant MeSH terms: Layout table for MeSH terms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Erlotinib Hydrochloride Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological

2008 Clinical Trials

125363. AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study

University Eye Center Durham, North Carolina, United States, 27705 United States, Oregon Devers Eye Center Portland, Oregon, United States, 97210 Sponsors and Collaborators Duke University Genentech, Inc. Investigators Layout table for investigator information Study Chair: Cynthia A Toth, MD Duke University Health System Principal Investigator: Thomas Hwang, MD Legacy Devers Eye Institute Principal Investigator: Baker Hubbard, MD Emory University Eye Center Principal Investigator: Wai T Wong, MD, PhD (...) for publication in peer-reviewed journals and posted on PubMed Central once accepted. We are supportive of efforts by publishers and professional societies to develop technologies for on-line publishing of entire experimental datasets. We will archive experimental results and findings from the proposed project for at least the duration of the project, and make the underlying datasets available to other researchers upon request. Keywords provided by Duke University: Spectral Domain Optical Coherence Tomography

2008 Clinical Trials

125364. A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy

University Study Details Study Description Go to Brief Summary: Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2 concluded them to be effective in the long-term. In our own double-blind, placebo-controlled study evaluating epidural etanercept, the results showed significant benefit in favor of the etanercept group, but no subject was included with a duration of pain > 9 (...) . Seventy-eight study participants will be randomized via a computerized randomization system using SPSS software in groups of 6 at each institution by a research nurse not involved in patient care. There will be 26 patients in each of the 3 groups. A physician unaware of the patient's treatment group will place 22-gauge needles in the relevant foramen under fluoroscopic guidance as determined by patient's symptoms and MRI findings. Once correct placement is confirmed by contrast injection, the blinded

2008 Clinical Trials

125365. Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)

and screened from clinic office visits and patient records at each principal investigator's site as well as through an investigational review board (IRB)-approved general advertisement. Those patients that continue to qualify after either screening process will be seen and evaluated by one of the clinical investigators prior to enrollment in the study. Subjects must meet criteria for the diagnosis of external nasal valve collapse as a stand alone abnormality (i.e., symptoms of obstruction cannot be caused (...) × 5) from baseline to 12 weeks post-procedure. Cosmetic Improvement [ Time Frame: 12 weeks after implantation ] An independent clinician will review Vectra 3D photographs of each subject at baseline and at 12 weeks post-procedure to assess physical appearance of the external nasal wall. The clinician will be asked to determine which photographs are pre-treatment and which are post-treatment in the correct order. The clinician will then rate the photograph chosen as post-treatment using the Global

2008 Clinical Trials

125366. Lag-3 and Gemcitabine for Treatment of Advanced Pancreas Cancer

of Medicine Information provided by (Responsible Party): Washington University School of Medicine Study Details Study Description Go to Brief Summary: The overall purpose of this research is to evaluate the safety and toxicity of an investigational medication, IMP321, in patients being treated with gemcitabine. IMP321 is a synthetic protein (made in the laboratory to simulate a protein that your body makes on its own) and was designed to stimulate the immune system with the overall objective of improving (...) Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patient must have a newly diagnosed, histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma (primary tumor or metastasis). The histological slides or blocks must be available for review. Patient must have advanced disease (characterized by metastasis or locally advanced disease), or unable to undergo surgical treatment due to extent of disease or pre-existing health conditions precluding surgical treatment

2008 Clinical Trials

125367. ExAblate Treatment of Uterine Fibroids for Fertility Enhancement

): InSightec Study Details Study Description Go to Brief Summary: The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility. Uterine fibroids are fairly common in women of child-bearing age. An evidence based review supported removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates (...) or systemic infection Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia Dermoid cyst of the ovary anywhere in the treatment path Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries) Undiagnosed vaginal bleeding Patients having a contraindication to pregnancy. Patients having a contraindication to surgery, including surgical myomectomy Patients with type 0

2008 Clinical Trials

125368. FTY720 in Patients With Primary Progressive Multiple Sclerosis

20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function (...) . Secondary Outcome Measures : Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS) [ Time Frame: up to 36 months after the last patient was randomized ] The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual

2008 Clinical Trials

125369. Observational Study on the Occurrence of Hepatosplenic T-cell Lymphoma in Patients of Netherlands

Lymphoma Other: No intervention Detailed Description: This is a observational, retrospective (a study in which the participants are identified and then followed backward in time, for the outcome of the study) study. In this study review of all reports of possible cases of hepatosplenic T-cell lymphoma (HSTCL) that were identified within the PALGA database of pathology results for The Netherlands from 1995 to 2008. All patients whose information is contained within the PALGA database were prescribed (...) participants Observational Model: Case-Only Time Perspective: Retrospective Official Title: A Retrospective Review of Reports of Hepatosplenic T-cell Lymphoma in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief [PALGA]), a Database of Pathology Results for The Netherlands Study Start Date : October 2008 Actual Primary Completion Date : April 2010 Actual Study Completion Date : April 2010 Resource links provided by the National Library of Medicine related

2008 Clinical Trials

125370. Sapropterin in Individuals With Phenylketonuria

with sapropterin as standard clinical care will be enrolled in the study. As a first step, patients with PKU will receive baseline neuropsychological and neuroimaging evaluations 1 day prior to beginning treatment with sapropterin. Screening for response to sapropterin will occur over 4 weeks. At the end of 4 weeks, response to sapropterin will be reviewed. Patients with a reduction of ≥ 20% in blood Phe (i.e., responders) will receive follow-up neuropsychological and neuroimaging evaluations after 6 months (...) . Screening for response to sapropterin (20mg/kg/day) will then occur over 4 weeks as standard care for enrolled patients. At the end of 4 weeks, response to sapropterin will be reviewed. Patients with a reduction of ≥ 20% in blood Phe (i.e., responders) will receive follow-up neuropsychological and neuroimaging evaluations after 6 months of treatment with sapropterin. Patients (both responders and nonresponders) will receive long-term follow-up neuropsychological and neuroimaging evaluations 3 to 5 years

2008 Clinical Trials

125371. Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus

of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU) ] Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. Number (...) of Participants Reporting Adverse Events That Are Treatment Limiting. [ Time Frame: End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU) ] Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited

2008 Clinical Trials

125372. A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis

) assigned to the study. The CSS will review adverse events and laboratory safety data and report any safety concerns to the Sponsor and a Data Safety Monitoring Committee (DSMC). At least 8 subjects must have safely completed study treatment for 28 days at a specific dose level, prior to escalation to the next dose group. The DSMC will convene to assess safety data when 8 subjects have completed study treatment for 28 days at the specific dose level. The role of the DSMC for the study will be complete (...) Examination (complete or brief) [ Time Frame: day -7, 1, 8, 15, 22, 29 ] SAFETY: Vital signs [ Time Frame: day -7, 1, 8, 15, 22, 29, 57 ] SAFETY: Clinical Laboratory Tests (hematology, serum chemistry, urinalysis) [ Time Frame: day -7, 1, 8, 15, 22, 29, 57 ] SAFETY: Analysis of hIL-10 (systemic exposure) and anti-hIL-10 antibodies (immunogenicity) in plasma [ Time Frame: day 1, day 29 ] SAFETY: Stool Diary [ Time Frame: From day -7 until day 29 ] SAFETY: Other Safety Measures (Stool samples for culture

2008 Clinical Trials

125373. Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. 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: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: PRE-REGISTRATION: Central pathology review submission; this review is mandatory prior to registration to confirm eligibility; it should be initiated as soon after

2008 Clinical Trials

125374. Evaluation of the Coloplast Titan® IPP for Maintaining Penile Length While Treating Erectile Dysfunction (ED)

at Maintaining or Increasing Penile Length After Implantation Study Start Date : December 2007 Actual Primary Completion Date : May 2010 Actual Study Completion Date : May 2011 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Titan® IPP Subjects implanted with Titan® IPP Device: Inflatable Penile Prosthesis Hydraulic system designed to be surgically implanted into the penis for the management of erectile dysfunction (...) expectancy of more than 5 years Has been diagnosed with erectile dysfunction Is willing to have the Titan IPP implanted Is able and willing to complete all follow-up visits and procedures indicated in this protocol Has been informed of the nature of the study and agrees to its provisions and - Has provided written informed consent as approved by the Institutional Review board of the respective site Exclusion Criteria: Participant has had a previous penile prosthesis or prior penile enlargement surgeries

2008 Clinical Trials

125375. A Study of Avastin (Bevacizumab) in Combination With mFOLFOX-6 or FOLFOXIRI in Patients With Metastatic Colorectal Cancer.

response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, where 'Complete response' was considered for those with 0 percent (%) viable tumor cells, 'Major response' for those with 1% to 49% viable tumor cells, 'Minor response' for 50% to 99% viable tumor cells, and 'No response' for 100% viable tumor cells. The response (...) of resective surgery, participants were evaluated for histopathological response as defined through pathologist review of the resected metastatic lesions, including assessment of margin status and tumor cell viability. Histopathological response classification was based upon the percentage of viable tumor cells, as described previously. The collective percentage of participants assessed as having a complete or major response was calculated as [number of participants with complete or major response divided

2008 Clinical Trials

125376. Bioequivalence Study of Amoxicillin Dispersible 600 mg Tablets Under Fasting Conditions

the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures If female and: of child bearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or is postmenopausal for at least 1 year; or is surgically sterile (bilateral tubal (...) ligation, bilateral oophorectomy, or hysterectomy) Exclusion Criteria: Volunteers with a recent history of drug or alcohol addiction or abuse Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators) Volunteers whose clinical laboratory test values are outside the accepted reference range and when

2008 Clinical Trials

125377. A Phase 1 Dose-escalation Study of a Cell Cycle Inhibitor With and Without Gemcitabine in Patients With Solid Tumors or Lymphoma (Study P05248)

gemcitabine. Standard therapy is defined as therapy that is approved in a particular line of therapy or considered as standard of care based on published peer reviewed data in a specific line of therapy. Gemcitabine-naïve participants with tumors known to be responsive to gemcitabine or participants previously treated with gemcitabine who did not progress while on treatment or who are currently still responding to treatment should only be enrolled in cohorts for which gemcitabine doses are >=1000 mg/m (...) with known Gilbert's Syndrome, must have adequate hepatic function as evidenced by a serum bilirubin level <=1.5 x the ULN AND serum levels of aspartate and alanine aminotransferase (AST/ALT) levels <=3 x the ULN for the reference lab (participants with known hepatic metastases must have serum AST/ALT levels <=5 x the ULN for the reference lab). Must be recovered from the effects of any prior surgery, radiotherapy or systemic antineoplastic therapy. Exclusion Criteria: Has a known hypersensitivity to MK

2008 Clinical Trials

125378. Pipeline for Uncoilable or Failed Aneurysms

written informed consent using the Institutional Review Board (IRB)-approved consent form Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements Exclusion Criteria: More than one IA requires treatment in the next 6 months Subarachnoid hemorrhage from target IA in the past 60 days Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days) Irreversible bleeding disorder Platelet count < 100 x 103 cells/mm3 (...) Numbers: COVPUFS0398 First Posted: October 22, 2008 Results First Posted: September 11, 2018 Last Update Posted: November 20, 2018 Last Verified: October 2018 Keywords provided by Medtronic Neurovascular Clinical Affairs: neurovascular embolization therapeutic embolization Additional relevant MeSH terms: Layout table for MeSH terms Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System

2008 Clinical Trials

125379. VIVITROL as a Treatment for Cocaine and Alcohol Dependence

medication, Wolff-Parkinson-White Syndrome, angina pectoris, documented history of myocardial infarction, heart failure). These are to be reviewed on a case-by-case basis: EKG 1st degree heart block, sinus tachycardia, left axis deviation, and nonspecific ST or T wave changes are allowed; liver function tests [LFTs] <3 x ULN are acceptable). Known hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent. Subjects with a BMI of 40 and above, as determined (...) abuse Additional relevant MeSH terms: Layout table for MeSH terms Alcoholism Cocaine-Related Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Ethanol Cocaine Naltrexone Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Alcohol Deterrents Narcotic Antagonists Sensory System Agents Peripheral Nervous System Agents Anesthetics, Local Anesthetics Vasoconstrictor Agents Dopamine

2008 Clinical Trials

125380. Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

the adjudication of events by a sponsor-independent, blinded review committee. Use was compiled from data recorded on the concomitant medications electronic case report form (eCRF) and compared to reported adverse events (AEs) to determine use for a respiratory event. The time to IV antipseudomonal antibiotic use was measured in days from baseline (Visit 2) to the date of first IV antipseudomonal antibiotic use or the date of study completion (last visit)/or early withdrawal if censored. Time to First (...) Respiratory Hospitalization [ Time Frame: Day 0 to Day 168 (end of study) ] This endpoint was determined through the adjudication of events by a sponsor-independent, blinded review committee. Committee members reviewed all hospitalizations and determined which were related to respiratory events. Details of all hospitalizations, including the dates of admission and discharge, were recorded on the serious adverse event (SAE) eCRF. Time to first respiratory hospitalization was the number of days from

2008 Clinical Trials

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