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125401. Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia

with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically (...) , by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible). Other Name: Risperdal Outcome Measures Go to Primary Outcome Measures : Pre and Post Treatment PET and MRI Imaging [ Time Frame: At baseline and 16 weeks

2008 Clinical Trials

125402. Functional Rehabilitation for Older Patients With Schizophrenia

provided by (Responsible Party): VA Office of Research and Development ( US Department of Veterans Affairs ) Study Details Study Description Go to Brief Summary: Aging and psychosis are major priority areas for VA. This project is a continuation of a Merit Review Program, in which we developed, manualized and conducted randomized controlled trials of a novel psychosocial rehabilitation intervention for older people with schizophrenia, called cognitive-behavioral social skills training (CBSST). We found (...) Review Program, in which we developed, manualized and conducted randomized controlled trials of a novel psychosocial rehabilitation intervention for older people with schizophrenia, called cognitive-behavioral social skills training (CBSST). We found that CBSST improved community functioning in these patients. CBSST, however, is an intensive program that may burden VA mental health clinics with demands for additional staff and financial resources and Veterans with travel and time demands. To reduce

2008 Clinical Trials

125403. Does Fish Oil Prevent Depression in Pregnancy and Postpartum?

help the immune system to function well. Some researchers have treated people who are already suffering from depression with fish oil. Some of these studies have shown a benefit for the fish oil treatment and others have not. These studies have tested EPA and DHA alone and in various combinations. Currently, it is not known whether EPA or DHA is more effective in preventing and treating depression. Some of the researchers involved in this study have learned how to identify mothers who are most (...) delivery ] While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery. Gestational Age at Delivery (Weeks) [ Time Frame: delivery date was assessed by medical record review between 1 day and 8 weeks after delivery ] Estimated Blood Loss (ml) [ Time Frame: Within 24 hours after delivery ] Neonatal Birthweight [ Time Frame: immediately

2008 Clinical Trials

125404. Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma

3.0 after each cycle of treatment. The maximum grade for each type of adverse event were recorded for each patient, and frequency tables were reviewed to determine patterns. For this endpoint, the number of patients receiving a Grade 3, Grade 4, or Grade 5 as their highest reported grade regardless of attribution are reported. A full list of adverse events are reported in the Adverse Events section of this report. Eligibility Criteria Go to Information from the National Library of Medicine (...) contraception Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse event of the prescribed regimen Patients known to be human immunodeficiency virus (HIV) positive Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina

2008 Clinical Trials

125405. Immediate Maintained Cannulation of a Newly Implanted Prosthetic Arteriovenous Access for Acute Hemodialysis

information, Layout table for eligibility information Ages Eligible for Study: Child, Adult, Older Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: No Sampling Method: Probability Sample Study Population Patients with end-stage renal disease underwent the specific prosthetic arteriovenous access creation in our hospital from November 2003 to October 2005 were retrospectively reviewed. Criteria Inclusion Criteria: end-stage renal disease underwent the specific prosthetic arteriovenous access (...) creation in our hospital from November 2003 to October 2005 Exclusion Criteria: patients' poor health as long as they did not have other options and needed an access for acute hemodialysis. Exclusions included shock, active systemic infection, and rejection by the attending nephrologists 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

2008 Clinical Trials

125406. Abuse Liability of Suboxone Versus Subutex

to Share IPD: Yes Plan Description: Data have been published in a peer-reviewed journal. Additional relevant MeSH terms: Layout table for MeSH terms Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Buprenorphine, Naloxone Drug Combination Heroin Naloxone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists

2008 Clinical Trials

125407. Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

researchers. Those external researchers interested in accessing the data will be required to submit a data analyses proposal with specific aims, hypotheses, and data analyses plan. These proposals will be reviewed by the investigative team. The requested data will then be provided that includes the variable list, raw data and description of the measures and methods of data collection. Keywords provided by University of Minnesota - Clinical and Translational Science Institute: Oral Tobacco Products Snus (...) Smoking Substitution Harm Reduction Biomarkers of Tobacco Exposure Additional relevant MeSH terms: Layout table for MeSH terms Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Nicotine Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

2008 Clinical Trials

125408. A Study for Participants With Metastatic Renal Cell Carcinoma

, then rest (no drug given) on Days 29-42. Part 2: Randomized Double-Blind: Dosing for Part 2 will be determined by outcome of Part 1. Phase 2 was not activated per recommendation of safety review committee. Enzastaurin: Cycle 1, Day 1 loading dose 375 mg administered po, TID, followed by Phase 1 dose BID on Days 2-42 of 6 week cycle. Sunitinib: 50 mg administered po, QD, on Days 1-28, then rest Days 29-42. Drug: Enzastaurin Administered orally Other Name: LY317615 Drug: Sunitinib Administered orally (...) 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: Participants with metastatic Renal Cell Carcinoma (RCC) who have not received prior treatment with systemic (adjuvant or neoadjuvant) therapy for RCC (including targeted therapy such as tyrosine kinase inhibitors or bevacizumab, immunotherapy, chemotherapy, hormonal, or investigational therapy) Histologically confirmed RCC

2008 Clinical Trials

125409. Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease

[ Time Frame: Baseline to the end of the Baseline period (up to 12 weeks) ] A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review. Secondary Outcome Measures : Percentage of Participants With a Diagnosis of ≥ CIN3 [ Time Frame: Baseline to the end of the study (up to 5 years, 1 month) ] A diagnosis of ≥ CIN3 (cervical intraepithelial (...) neoplasia) included histology results of CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma. The diagnosis was based on central pathology review. 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

2008 Clinical Trials

125410. Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC

) and within the institutional range of normal. Subjects with stable central nervous system metastases (stable for at least 3 months) as confirmed by computerized tomography (CT)/magnetic resonance imaging (MRI) or evidence of leptomeningeal involvement were eligible only if they were not taking steroids or enzyme-inducing anticonvulsants. Subject must have been free of gastrointestinal diseases that impede swallowing and retaining of oral medications. Signed, informed consent prior to registration (...) with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com Layout table

2008 Clinical Trials

125411. A Clinical Trial of Magnetic Stimulation in Depression

: Patient medications will be reviewed prior to enrollment in this study. Patients taking medications that may lower seizure threshold (e.g. metronidazole) will be excluded if the particular medication cannot be stopped or altered without affecting the patient's routine medical care. History of neurological illness, epilepsy or seizure disorder, intracranial tumor, or major head trauma leading to loss of consciousness of any length. Evidence of central nervous system disease based on baseline complete (...) Georgia Veterans Health System Gainesville, Florida, United States, 32608 Sponsors and Collaborators US Department of Veterans Affairs University of Florida Investigators Layout table for investigator information Principal Investigator: Stephen E. Nadeau, MD BS BS North Florida/South Georgia Veterans Health System More Information Go to Publications: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Layout table for additonal information Responsible Party

2008 Clinical Trials

125412. Effects of Dexmedetomidine on the Intraoperative Electroencephalogram During Endarterectomy Surgery

Identifier: UC Davis, Institutional Review Board ) 200513433-5 ( Other Identifier: UC Davis, Institutional Review Board ) First Posted: July 4, 2008 Last Update Posted: May 30, 2017 Last Verified: May 2017 Keywords provided by University of California, Davis: Dexmedetomidine Carotid Endarterectomy Electroencephalogram Additional relevant MeSH terms: Layout table for MeSH terms Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non (...) these procedures. Although this is consistent with our clinical impression, the effects of dexmedetomidine on the perioperative course and EEG monitoring have not been objectively evaluated at our institution. Condition or disease Intervention/treatment Endarterectomy, Carotid Drug: Dexmedetomidine Detailed Description: Fifty sequential patient records will be identified from a search of the OR surgical schedules and reviewed: 25 patients before the introduction of dexmedetomidine and a standard anesthetic

2008 Clinical Trials

125413. Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients

). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step. Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Drug: TA-7284 Drug: Placebo of TA-7284 Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 61 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care (...) weeks Prior to dosing Medicines if necessary for Hypertension or Dyslipidemia should be administered with stable dosage at least 3 months Treatment with diet and exercise should be unchanged for more than 3 months Exclusion Criteria: Type 1 Diabetes Mellitus or Secondary Diabetic Mellitus History of diabetic complications which need treatment Treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent Serum creatinine

2008 Clinical Trials

125414. Safety and Tolerability of Vortioxetine (Lu AA21004) in Adults With Major Depressive Disorder

Outcome Measures Go to Primary Outcome Measures : Physical Examination Findings [ Time Frame: Baseline and Week 52 ] Physical examination consisted of the following body systems: (1) appearance; (2) extremities; (3) skin; (4) head and neck; (5) eyes, ears, nose, and throat; (6) lungs and chest; (7) heart and cardiovascular system; (8) abdomen; and (9) musculoskeletal system. An assessment of the nervous system was conducted; any findings were captured under the appropriate body area. Each system (...) Frame: Weeks 4, 12, 24, 36 and 52 ] A standard 12-lead ECG was performed at the designated study visits. The central reader reviewed and recorded the intervals (PR, QRS, RR, QT, and corrected QT interval [QTc]), and interpreted the ECG using 1 of the following categories: within normal limits or abnormal. The number of participants with at least one post-baseline potentially clinically significant ECG finding is reported. bpm = beats per minute; QTcB = QT interval corrected using Bazett's formula

2008 Clinical Trials

125415. Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures

: Through Postoperative Day 3 ] Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period [ Time Frame: Through Postoperative Day 14 (± 1) ] Secondary Outcome Measures : Visual Comparison of Ecchymosis at Day 1 [ Time Frame: Through Postoperative Day 1 ] Comparison between (...) the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. Visual Comparison of Ecchymosis at Day 5 [ Time Frame: Through Postoperative Day 5 ] Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. Visual Comparison of Ecchymosis at Day 7 [ Time Frame: Through

2008 Clinical Trials

125416. Anti-MART-1 F5 Lymphocytes to Treat High-Risk Melanoma Patients

and given medicines to prevent or treat any side effects of therapy. Leukapheresis: Patients undergo leukapheresis at 1 and 3 months after therapy to collect cells to examine the effects of the treatment on the immune system. Follow-up: Patients return to National Institutes of Health (NIH) 35 days after completing treatment and then at 3 months and every 6 months thereafter for evaluation with a physical examination, review of side effects, laboratory tests and scans. They have blood tests at 3, 6 (...) (F5) to target and destroy their tumor. Some of the cells are given as an infusion and others are given as a vaccine. The anti-MART-1 F5 cells are currently being studied in other patients in combination with chemotherapy and IL-2 (aldesleukin) therapy. Objectives: -To determine if the anti-MART-1 F5 treatment can improve the immune system's ability to shrink tumors and to prevent melanoma from recurring. Eligibility: Patients 18 years of age and older whose melanoma has been removed

2008 Clinical Trials

125417. Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

information Ages Eligible for Study: 18 Years to 60 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by Institutional Review Board/Independent Ethics Committee [IRB/IEC]), prior to the initiation of any protocol-required procedures. Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent (...) & Commercialization, Inc.: Aripiprazole Intramuscular (IM) depot Schizophrenia Additional relevant MeSH terms: Layout table for MeSH terms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Aripiprazole Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin 5-HT1 Receptor

2008 Clinical Trials

125418. Treatment of Unresectable Hepatocellular Cancer With Opioid Growth Factor

obstructive pulmonary disease, unstable cardiovascular diseases (congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias, poorly controlled hypertension, have suffered a myocardial infarction in the preceding year or have an abnormal EKG) will not be allowed. Patients with poorly controlled diabetes, seizure disorders, primary central nervous system (CNS) tumors or known brain metastases are excluded. A clinical judgment will be made based on the other criteria and performance (...) status as to the patient's ability to tolerate therapy. Serum total bilirubin and international normalized ratio (INR) will be used as markers of liver function in the exclusion criteria as defined in Table 1 (see below). Pregnant or nursing women are not eligible. Patients requiring antibiotics in the preceding week for a serious infection are not eligible. Volunteers may have on the morning of the study one 8 ounce glass of water or juice and toast. EKG and laboratory tests will be reviewed

2008 Clinical Trials

125419. Usefulness of Topical Non-Steroidal Anti-Inflammatory Drugs or Steroids Before Trabeculectomy and Clinical Outcomes

surgery. Condition or disease Intervention/treatment Phase Glaucoma Trabeculectomy Fibrosis Intraocular Pressure Drug: ketorolac acetate Drug: fluorometholone Drug: artificial lacrimal tears Phase 3 Detailed Description: This prospective double-blind randomized placebo-controlled clinical trial was approved by our institutional review board and adheres to the tenets of the Declaration of Helsinki. Patients who agree for the study had to sign an informed consent. Eligible subjects will be subsequently (...) table for MeSH terms Ketorolac Anti-Inflammatory Agents, Non-Steroidal Fluorometholone Anti-Inflammatory Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Allergic Agents

2008 Clinical Trials

125420. Adjunctive Antimicrobial Therapy of Periodontitis: Long-Term Effects on Disease Progression and Oral Microbiological Colonization

periodontitis patients. Condition or disease Intervention/treatment Phase Periodontitis Drug: Amoxicillin and Metronidazole Drug: Placebo Phase 4 Detailed Description: Periodontitis is an endemic inflammatory disease caused by a mixed bacterial biofilm infection that is followed by destruction of tooth supporting tissues. Standard of care consists of lifelong mechanical removal of the biofilm. However, outcome is variable. According to recent EFP and AAP reviews, adjunctive antimicrobial therapy may (...) -ratiopharm® 500mg as listed in the "summary of product characteristics, Version Juli 2005"), metronidazole (or other 5-nitroimidazoles and ingredients of Flagyl® 400mg as listed in the "summary of product characteristics, Version Juli 2007"), systemic diseases or conditions as listed in the above mentioned "summary of product characteristics", or show confirmed lactose intolerance; have Down's syndrome; known AIDS/HIV; regularly take systemic medication affecting the periodontal conditions, e.g

2008 Clinical Trials

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