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125381. Neonatal Intensive Care (NICU) Course and Hospital Outcome of Infants With BPD Treated Using Inhaled Nitric Oxide

, 2008 Last Update Posted : June 24, 2010 Sponsor: University of Utah Information provided by: University of Utah Study Details Study Description Go to Brief Summary: This is a chart review study of neonates admitted to Primary Children's Medical Center or University of Utah NICU who had or developed a diagnosis of bronchopulmonary dysplasia (BPD) and were treated for this condition with inhaled nitric oxide (iNO) beginning after the 4th week of life. For this study BPD will be defined as need (...) : up to 28 Days (Child) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Non-Probability Sample Study Population Any patient who at 28 days of life was requiring oxygen therapy in the Neonatal Intensive Care Unit and who was then treated with iNO would be eligible for chart review. Since iNO therapy has only been available for a few years, this study will attempt to capture all patients who qualify. Any patient who received iNO treatment under an IRB study protocol

2008 Clinical Trials

125382. Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

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: Must sign an Institutional Review Board (IRB) -approved informed consent form (...) , indicating his/her awareness of the investigational nature of decitabine and its potential hazards prior to initiation of any study-specific procedures or treatment. Must have had one of the following: MDS (de novo or secondary) fitting any of the recognized French-American-British classifications OR chronic myelomonocytic leukemia (with WBC <12,000/μL) AND an International Prognostic Scoring System score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics

2008 Clinical Trials

125383. ArterX Surgical Sealant, A Randomized Prospective Multicenter Trial

and Thrombin Phase 3 Detailed Description: To evaluate, during open vascular surgery, the safety and effectiveness of the ArterX™ Vascular Sealant when applied prophylactically. Application will be at synthetic vascular graft or patch to native vessel anastomosis prior to the restoration of full systemic circulation to achieve suture line sealing. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 217 participants Allocation: Randomized (...) or guardian must provide written informed consent using a form that is reviewed and approved by the IRB. Exclusion Criteria: Subjects will be excluded from the Study if any of the following criteria are met: The subject has a known hypersensitivity or contraindication to heparin, bovine or seafood products. The subject has a history of bleeding diathesis or coagulopathy, or will refuse blood transfusions. The subject is currently enrolled in this, or another investigational device or drug trial (IDE

2008 Clinical Trials

125384. A Novel Treatment for Metastatic Melanoma

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: NCT00758797 Recruitment Status : Terminated (Study was not renewed during annual Northwestern Cancer Center review.) First Posted : September 25, 2008 Last Update Posted : May 23, 2014 Sponsor: Northwestern University Information provided by (Responsible Party): Murad Alam (...) , Northwestern University Study Details Study Description Go to Brief Summary: A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream. Condition or disease Intervention/treatment Phase Metastatic Melanoma Other: Photoimmunotherapy Phase 1 Detailed Description: A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream with or without injection of a substance that makes the tumor more sensitive to the laser. Study Design Go

2008 Clinical Trials

125385. Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.

contraceptives (i.e. pill, patch, ring, injection, implant), intrauterine device (IUD), diaphragm with spermicide or condom with spermicide. The incidence of DME will be determined by 2 methods: Diagnosis of clinical DME can be made by the masked investigator during the study based on the investigator's medical opinion and expertise Diagnosis of DME by a masked clinical specialist will review all Optical Coherence Tomography (OCT) after conclusion of study. The diagnosis will be stratified into 3 categories (...) Macular Edema Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Bromfenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents

2008 Clinical Trials

125386. Characterization of WAGR Syndrome and Other Chromosome 11 Gene Deletions

, suggesting that BDNF may play an important role in human energy balance as well as pain sensation. We now propose to conduct a comprehensive clinical phenotype-genotype study on patients with WAGR syndrome and other 11p deletions. We plan to enroll 75 subjects with WAGR syndrome/11p deletions who will undergo evaluations of the following systems: metabolic/endocrine, sensation/nociception, ophthalmologic, audiologic, neurocognitive, renal/genitourinary, oncologic, dental/craniofacial, cardiac (...) medications. Use of as-needed and over-the-counter medications will be reviewed on a case-by-case basis by the Principal Investigator No chronic medical or psychiatric conditions anticipated to affect results or impede study participation For aniridia subjects: Diagnosis of aniridia confirmed by ophthalmologist Age greater than or eqaul to 2 years old (Subjects age 2-6y will only have an outpatient evaluation, one 60 mL (or 5 mL/kg if weight <12 kg) blood draw, eye examination, and cognitive, behavioral

2008 Clinical Trials

125387. [Trial of device that is not approved or cleared by the U.S. FDA]

Mammography system 3 dimensional breast mammography system 3D Imaging with commercial Mammography Device Device: Genesis and Gemini 3 dimensional breast mammography system Other Name: Selenia Dimensions Outcome Measures Go to Primary Outcome Measures : Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design [ Time Frame: 1 year ] images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group (...) [Trial of device that is not approved or cleared by the U.S. FDA] A Pilot Study - Comparison of Two Hologic 3D Mammography Systems - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. A Pilot Study - Comparison

2008 Clinical Trials

125388. Perceptions Regarding Investigational Screening for Memory Problems in Primary Care

the public's acceptance or enthusiasm for early recognition of dementia. Based on this model, prior research and clinical experiences, and a systematic literature review, the PRISM-PC instrument was developed. The PRISM-PC items seek to capture both the patient's acceptance of dementia screening and the patient's perception of potential harms and benefits of such screening. The instrument includes questions regarding screening by performance-based questionnaires, blood tests, or brain imaging. The PRISM-PC (...) Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders

2008 Clinical Trials

125389. Prevention of Postoperative Nausea and Vomiting in Surgical Patients

eligible for treatment. Exclusion Criteria: Patients <18 years old Patients with a history of hypersensitivity to cannabinoids or sesame oil --Patients with current substance abuse. Substance abuse will be identified meeting one or both of the following criteria: a) Review the participant's medical chart to identify inpatient, residential, or outpatient treatment for alcohol or drug dependence as recorded in the Veterans Health Administration Computerized Patient Record system (CPRS) within (...) the preceding six months. OR b) Patient report. Exclude patients who report current marijuana or cocaine use within the past 30 days. If a drug screen is clinically indicated and is positive the patient will NOT be entered into the study. Patients taking medications known to have significant drug-drug interactions with the prescribed drug and study drugs, Dronabinol and Ondansetron, will be reviewed in Micromedex. Micromedex is a medication database used by Central Arkansas Veterans Healthcare System (CAVHS

2008 Clinical Trials

125390. Keppra for Cervical Dystonia

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: NCT00760318 Recruitment Status : Terminated (Sponsor decided to stop enrollment to review data.) First Posted : September 26, 2008 Last Update Posted : November 22, 2018 Sponsor: University of South Florida Information provided by: University of South Florida Study Details Study Description Go to Brief Summary (...) with a copy sent to UCB and the USF Internal Review Board. A comparison across groups of the number of subjects who require injections prior to week 16 will be undertaken. In addition, a comparison across groups of the number of subjects not requiring injections at week 16 will be performed. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 17 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple

2008 Clinical Trials

125391. Hormone Function in Men Treated for Pain With Opioids or Placebo

as needed, but no other pain medications or treatments. They are monitored two or three times a week by telephone and complete a pain diary. After the second hospitalization, subjects are tapered off the study medication. After 2 to 4 weeks of stopping medication, they return for a final outpatient visit to review pain or other medical problems and to have blood drawn. Condition or disease Intervention/treatment Phase Chronic Pain Osteoarthritis Drug: MS Contin Drug: Placebo Phase 4 Detailed Description (...) intended to evaluate the effect of long term opioid usage AND the placebo effect if any- on the same hormones in men with chronic OA pain. Therefore the NCCAM study had a three arm design comparing MS Contin to placebo and standard treatment. When the protocol was being revised under NINR, review of the placebo literature suggested that placebo effect becomes negligible with time and therefore a two arm design was chosen comparing morphine to placebo. Baseline overnight blood hormone sampling, doses

2008 Clinical Trials

125392. A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal. Drug: lenalidomide 25mg oral capsules continuous days 1-21 each of a 28 day cycle Other Name: Revlimid Outcome Measures Go to Primary Outcome Measures : Percentage of Participants Who Achieved an Overall Response According to the Independent Review Committee (IRC) [ Time Frame: From Day 1 of study treatment to progession or early treatment discontinuation (...) Meier Estimate of Duration of Response (DoR) According to the Independent Review Committee [ Time Frame: From Day 1 of study drug to progression or early treatment discontinuation; up to data cut-off date of 06 April 2016; Median duration of treatment was 94.5 days. ] Kaplan Meier estimate for the duration of response (DoR) was calculated from the date of the first occurrence of initial response for responders (demonstrating evidence of at least a PR) to the date of first documented disease

2008 Clinical Trials

125393. Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

Tissue available and willing to submit tissue for central pathology review and EGFR evaluation; performed on original diagnostic/recurrent tissue (preferably paraffin-embedded tissue blocks); if institution unable to release tissue blocks, willing to submit 25 unstained slides (15 sections cut at 5 microns mounted on charged slides and 10 sections cut at 10 microns mounted on uncharged slides) Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain (...) cytotoxic agent(s); adjuvant/neoadjuvant treatment with cytotoxic agent(s) administered < 12 months (from date chemotherapy was started) prior to pre-registration will be considered as one prior treatment; NOTE: adjuvant/neoadjuvant treatment administered >= 12 months, use of targeted agents such as monoclonal antibodies prior to pre-registration will NOT be counted as one prior treatment; patient could have had adjuvant/neoadjuvant chemotherapy >= 12 months and 1 systemic chemotherapy regimen

2008 Clinical Trials

125394. An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer

signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 415 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Randomized, Double (...) or the cutoff date, whichever was earlier. Secondary Outcome Measures : Best Overall Response [ Time Frame: Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months ] BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical

2008 Clinical Trials

125395. IDO Inhibitor Study for Relapsed or Refractory Solid Tumors

Outcome Measures : Preliminarily characterize effects of D-1MT on serum kynurenine levels as a biomarker for systemic IDO activity. [ Time Frame: 3 months ] 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: A histological or cytological diagnosis of recurrent or refractory solid tumor malignancy. The patient's pathology must be reviewed and confirmed prior to enrollment (outside reviews acceptable). If no standard therapy exists for disease or subject refused standard therapy

2008 Clinical Trials

125396. Diabetes in the Perioperative Period

levels in surgical patients with and without diabetes are associated with increased risk of medical complications and death. Over the short-term, high blood glucose can adversely affect fluid balance, impair immunologic response to infection, and promote inflammation and endothelial dysfunction (blood vessel function). Blood glucose control with intensive insulin therapy in patients with critical illness (very sick patients in intensive care unit) reduces the risk of multiorgan failure and systemic (...) period (before and after surgery) in non-critically ill patients. Therefore, the present study aims to evaluate the impact of high blood glucose, in large number of subjects with and without diabetes, during general (non-cardiac) surgery. Condition or disease Hyperglycemia Diabetes Detailed Description: We will perform a retrospective chart review of all patients who underwent non-cardiac surgery from 01/01/07 to 06/30/07 at Emory University Hospital as inpatient. Study Design Go to Layout table

2008 Clinical Trials

125397. Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease

death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. [ Time Frame: Reviewed 6-monthly; average patient follow up, 4.5 years ] Secondary Outcome Measures : Composite of CV death, MI & ischaemic stroke; components of primary composite endpoint; re-vascularisation procedures; all-cause death; new onset atrial fibrillation; new onset diabetes; OSA symptom scores; mood; health (...) -related quality of life. [ Time Frame: Reviewed 6-monthly; average patient follow up, 4.5 years. ] In a sub-sample of 600 subjects pathophysiological mechanisms of CPAP-induced CV event reduction will be explored by assessing various intermediate markers of CV risk [ Time Frame: baseline and at 6-months, 2 and 4 years following randomisation ] Cardiac MRI to assess effects of CPAP on cardiac structure and function. [ Time Frame: Randomisation and at 6 months follow-up ] In a sub-sample of 150

2008 Clinical Trials

125398. A Study To Investigate Safety, Blood Levels And Effects Of Giving GW642444, By Mouth, By Inhalation & By Injection

the study will measure how much of the medicine gets into the bloodstream when it is given by mouth, by injection into a vein and inhaled, and how long the body takes to get rid of it. Condition or disease Intervention/treatment Phase Pulmonary Disease, Chronic Obstructive Drug: GW642444 Phase 1 Detailed Description: This will be a single-centre, open-label, dose-ascending study in 9 healthy male subjects to establish safe and well tolerated systemic exposure safety margins for GW642444 following (...) and glucose, laboratory safety data and review of adverse events [ Time Frame: Various ] Secondary Outcome Measures : Plasma PK parameters for IV, inhaled and oral routes of administration [ Time Frame: Various ] Urine PK parameters for the intravenous and inhaled routes of administration [ Time Frame: Various ] 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

2008 Clinical Trials

125399. Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)

at the end of the study or if complications necessitate breaking of the code. Both groups will undergo urodynamic testing to document before and after treatment data. Bladder biopsies will be taken prior to treatment in both groups that will be analyzed for nerve growth factor. Three day voiding diaries will be kept and reviewed with the study coordinator at the follow up visits. Quality of life questionnaires will be completed at each follow up visit. The treatments will take place on Day 0 and Day 90 (...) , Neurogenic Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Neurologic Manifestations Urinary Bladder Diseases Urologic Diseases Signs and Symptoms Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents

2008 Clinical Trials

125400. Phase I Study of HIV Adenoviral Vector Vaccine in Healthy Subjects Using Needle or Biojector Injection

one injection of the study rAd5 vaccine. Subjects in both groups are randomly assigned to receive the vaccine by needle or Biojector 2000 (Registered Trademark) into a muscle in the upper arm. They call a study nurse 2 days after the injection, record their temperature and symptoms on a diary card at home for 5 days after the injection for later review, and visit the clinic two weeks after the injection for a checkup. The injection is given on the day of enrollment. Additional visits are scheduled (...) of Medicine related topics: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : Safety (local and systemic reactogenicity, lab tests, AEs) Secondary Outcome Measures : Immunogenicity (cellular and humoral immune function assays) 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

2008 Clinical Trials

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