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125301. Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Cruris

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: 12 Years and older (Child, Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Review and sign a statement of Informed Consent and HIPAA authorization. Males or non-pregnant females ≥12 years of age, of any race or sex (...) therapies within 3 months of randomization (8 months for oral terbinafine). Systemic antibiotic or corticosteroid treatment within 30 days of randomization. Any other significant treatments, except hormonal contraception and multivitamin, at the discretion of the investigator that would interfere with study treatment. Investigational drug/ device within 30 days of randomization Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your

2008 Clinical Trials

125302. Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis

: Review and sign a statement of Informed Consent and HIPAA authorization. For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate). Males or non-pregnant females ≥12 years of age, of any race or sex. Females of childbearing potential must have a negative urine pregnancy test. Presence of tinea pedis on one or both feet characterized by clinical evidence (...) method should subject become sexually active. Subjects using the following medications: Topical anti-fungal therapy, foot/shoe powders, or topical corticosteroids applied to the feet within 14 days prior to randomization. Topical terbinafine, butenafine,and naftifine within 30 days prior to randomization Oral anti-fungal therapies 3 months (8 months for oral terbinafine) prior to randomization Systemic antibiotic or corticosteroid treatment within 30 days of randomization Any other significant

2008 Clinical Trials

125303. Personalized Information or Basic Information in Helping Patients Make Decisions About Participating in a Clinical Trial

information is more effective than basic information in helping patients make decisions about clinical trials. PURPOSE: This randomized phase III trial is studying personalized information to see how well it works compared with basic information in helping patients make decisions about participating in a clinical trial. Condition or disease Intervention/treatment Phase Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple (...) trial and completing the consent process during their initial physician consultation. Each patient's physician completes a brief Physician Post-Consultation Assessment to define cancer stage, treatment goal, and to determine whether clinical trials were offered and accepted and if not, why not. For patients who have not made a treatment decision after consultation, a brief follow-up phone survey or medical chart review is used to identify the patient's treatment choice. Study Design Go to Layout

2008 Clinical Trials

125304. Phase 1/2 Safety and Efficacy Study of AAV-RPE65 Vector to Treat Leber Congenital Amaurosis

-hRPE65. Participants in Group 2 will receive 450 µL at a dosage level of 1.33 x 10^12 vg/mL containing a total of 6 x 10^11 vg of rAAV2-CB-hRPE65. A retinal surgeon will administer the vector by subretinal injection. Enrollment will begin with Group 1 and will proceed to Group 2 after review of safety data by a Data and Safety Monitoring Committee. Safety will be monitored by evaluation of ocular and non ocular adverse events and hematology and clinical chemistry parameters. Efficacy will be measured (...) for use in the peri-operative period; For females of childbearing potential, a positive pregnancy test at screening or baseline (within 2 days before rAAV2-CB-hRPE65 administration); Females who are breast feeding; Use of any investigational agent, or systemic corticosteroids or other immunosuppressive drug(s), within 3 months prior to enrollment; Prior receipt of any AAV gene therapy product; Any condition which leads the investigator to believe that the participant cannot comply with the protocol

2008 Clinical Trials

125305. Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy

Pain Relief System. Condition or disease Intervention/treatment Phase Pain, Postoperative Drug: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) Drug: ON-Q PainBuster Post-op Pain relief System Phase 2 Detailed Description: Hysterectomy is the second most common surgery among women in the United States (US). Abdominal hysterectomy surgery may be performed to treat benign tumors, such as fibroids, heavy periods, painful periods and chronic pelvic pain. The most common route for performing (...) and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery. The ON Q system consists of 1 elastometric pump with a fill volume of 270 mL containing 0.25% bupivacaine; 1 soaker catheter measuring 12.5 cm in size; and a fill port, tubing, clamp, filter and flow restrictor. The pump provides positive pressure and is portable. It may be attached to the patient's dressing

2008 Clinical Trials

125306. Pilot Study for Patients With Poor Response to Deferasirox

will be obtained and reviewed for eligibility. At that visit patients will be able to sign informed consent. Shortly thereafter patients will be admitted to the GCRC at Children's Hospital Boston for part I of the study, a 2-3 day stay during which PK and nuclear medicine studies will be performed as well as the deferoxamine urinary iron excretion challenge. Patients who are eligible will continue on to part II of the study, and for 3 months and will be monitored for compliance, PK and ferritin changes (...) criteria for Part I: Pregnancy (as documented in required screening laboratory test) or breast feeding History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative Patients with transfusion requirements equal to or more frequent than every three weeks. AST or ALT > 400 U/L during screening Patients with uncontrolled systemic hypertension Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary

2008 Clinical Trials

125307. Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer

of disease progression or unacceptable toxicity. Patients complete quality-of-life assessments periodically using the EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4 questionnaires. After completion of study treatment, patients are followed periodically for up to 7 years. Peer Reviewed and Funded by Medical Research Council (MRC) Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 6088 participants Allocation: Randomized Intervention (...) : September 9, 2008 Last Update Posted: July 27, 2018 Last Verified: July 2018 Keywords provided by Laura Alexander, Cancer Research UK, Glasgow: stage II colon cancer stage III colon cancer stage II rectal cancer stage III rectal cancer Additional relevant MeSH terms: Layout table for MeSH terms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases

2008 Clinical Trials

125308. The Canadian Follow-up Program for the ATTRACT Study (P04868)(TERMINATED)

. Information provided by (Responsible Party): Merck Sharp & Dohme Corp. Study Details Study Description Go to Brief Summary: This is a Phase 4, retrospective chart review of subjects that participated in the ATTRACT study. Site investigators will conduct a chart review and complete a data collection form. The purpose of this study is to describe the treatment used and clinical outcomes of these subjects following completion of the ATTRACT trial up until their most recent assessment by the treating (...) physicians. Condition or disease Intervention/treatment Arthritis, Rheumatoid Other: Retrospective Chart Review and Data collection Detailed Description: Subjects were selected for this study using a non-probability sampling method. Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 13 participants Observational Model: Cohort Time Perspective: Retrospective Official Title: The Canadian ATTRACT Follow-up Program Study Start Date : September 2006 Actual

2008 Clinical Trials

125309. BRAVO: Background Regimen of Raltegravir on Virologic Outcome

provided by (Responsible Party): Community Research Initiative of New England Study Details Study Description Go to Brief Summary: This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen. Condition or disease Intervention/treatment HIV Infections Drug: raltegravir Detailed (...) Description: EAP charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. A comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (PI) with those that did not contain a PI. Other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, CD4 cell changes, consequences of failure

2008 Clinical Trials

125310. A Dose Proportionality Study of Quinine Sulfate Capsules Under Fasting Conditions

and Weight Table Screening procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both screening evaluation and human immunodeficiency virus (HIV) antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting (...) blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems. The screening clinical laboratory procedures will include: HEMATOLOGY: hematocrit, hemoglobin, white blood cell (WBC) count with differential, red blood cell (RBC) count, platelet count; CLINICAL CHEMISTRY: serum creatinine, blood urea nitrogen (BUN), glucose, AST(SGOT - Serum

2008 Clinical Trials

125311. Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors

×ULN (<5×ULN for patients presenting with liver involvement) White blood cell count ≥3.0×109/L Absolute neutrophil count (ANC) ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥10 g/dL Written informed consent in compliance with ZIOPHARM policies and the Institutional Review Board (IRB) having jurisdiction over the site Ability and willingness to undergo multiple venous punctures for serum PK sampling For the second phase of the trial (expanded cohort of 10), only capecitabine-naïve subjects (...) ., tumor involving major vessels or known varices) Pregnancy and/or lactation. To be enrolled, each woman of childbearing potential must have a negative pregnancy test, which will be repeated at the end of the study. Uncontrolled systemic infection (documented with microbiological studies) Anticancer chemotherapy or immunotherapy within 4 weeks of study entry or at any time during the study or investigational drug therapy outside of this trial during or within 4 weeks of study entry Mitomycin C

2008 Clinical Trials

125312. Study of HCV Genotype 1 Patients in the UK Treated With ViraferonPeg and Rebetol (Study P05269)(COMPLETED)

: June 7, 2010 Last Update Posted : September 25, 2015 Sponsor: Merck Sharp & Dohme Corp. Information provided by (Responsible Party): Merck Sharp & Dohme Corp. Study Details Study Description Go to Brief Summary: The study is designed as a retrospective data review of medical records from participants selected from specialist secondary and tertiary care centers across the United Kingdom (UK), specializing in Hepatitis C treatment. The study is non-interventional and is designed to identify subgroups (...) Identifier: Other Study ID Numbers: P05269 First Posted: July 29, 2008 Results First Posted: June 7, 2010 Last Update Posted: September 25, 2015 Last Verified: September 2015 Additional relevant MeSH terms: Layout table for MeSH terms Hepatitis C Hepatitis C, Chronic Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Ribavirin Peginterferon alfa-2b Interferon-alpha Antimetabolites Molecular Mechanisms

2008 Clinical Trials

125313. Standard Process 21 Day Purification Program Project

levels over 180. Condition or disease Intervention/treatment Phase Hyperlipidemia Other: Standard Process 21 Day Purification Program (SPPP) Phase 1 Phase 2 Detailed Description: Elevated low-density lipoprotein (LDL) cholesterol concentrations are a risk factor for cardiovascular diseases. (1) Cholesterol lowering drugs are the most frequently prescribed medications in the U.S. and are known to have muscle, kidney and liver side effects for some users. Recent reviews conclude that benefits outweigh (...) improved results with more plant-based foods, such as whole grains, vegetables, legumes, and fruits while simultaneously limiting saturated fat and cholesterol. (17) It has been reported that nutritional supplements and diet can reduce serum lipids and blood pressure. There are no reports on the effects of nutritional supplement on HRV despite the close link of the autonomic nervous system activity on regulation of blood pressure. The Standard Process 21 day Purification Program consists

2008 Clinical Trials

125314. Preventive Health Behavior in Women

of womens health related issues Group 2 Women who receive only a CRC-related questionnaire. Group 3 Women who receive neither questionnaire nor educational video. Behavioral: Behavioral Study in Women A Randomized study to assess the knowledge of womens health related issues Outcome Measures Go to Primary Outcome Measures : The primary outcome will be determined through review of medical records or a telephone follow-up 6 months after enrollment [ Time Frame: At 6 month intervals ] Eligibility Criteria (...) System Ann Arbor, Michigan, United States, 48109 Sponsors and Collaborators University of Michigan Investigators Layout table for investigator information Principal Investigator: Ruth Carlos, MD University of Michigan More Information Go to Layout table for additonal information Responsible Party: Ruth Carlos M.D., Principal Investigator, University of Michigan ClinicalTrials.gov Identifier: Other Study ID Numbers: HUM00048680 First Posted: July 29, 2008 Last Update Posted: December 16, 2016 Last

2008 Clinical Trials

125315. Treatment of Acetaminophen Toxicity With N-acetylcysteine

Study Description Go to Brief Summary: Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs. Condition or disease Acetaminophen Toxicity Study Design Go to Layout table for study information Study Type : Observational Estimated Enrollment : 130 participants Observational Model: Case-Only Time Perspective: Retrospective Official Title: Treatment of Acetaminophen Toxicity With Intravenous vs Oral N (...) -acetylcysteine: A Retrospective Review Study Start Date : August 2008 Actual Primary Completion Date : September 2008 Actual Study Completion Date : October 2008 Resource links provided by the National Library of Medicine available for: Groups and Cohorts Go to Group/Cohort 1 Patients receiving oral NAC treatment 2 Patients receiving IV NAC treatment Outcome Measures Go to Primary Outcome Measures : Duration of oral vs IV NAC treatment in hours [ Time Frame: From admission to discharge ] Secondary Outcome

2008 Clinical Trials

125316. Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers

: Completed First Posted : July 30, 2008 Last Update Posted : December 8, 2009 Sponsor: AVIR Green Hills Biotechnology AG Information provided by: AVIR Green Hills Biotechnology AG Study Details Study Description Go to Brief Summary: The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1 administered as single dose intranasal aerosol for vaccination against influenza A (H1N1) virus. This study is performed further to assess local and systemic immune response and to analyse (...) I dose escalation study investigating five dose levels. 8 subjects per each of the five dose levels and additional 8 subjects at the highest dose level respectively the maximum tolerated dose level will be randomized at a ratio of 6:2 for GHB01L1 or placebo according to a fixed dose escalation plan. After all subjects of one dose level have been treated and observed for the safety observation period of one week, an interim safety review will be performed by an Expert Committee. The Expert

2008 Clinical Trials

125317. Study to Determine the Safety and Efficacy of Ruxolitinib (INCB018424) in Patients With Polycythemia Vera or Essential Thrombocythemia

on an individual basis using their discretion in order to achieve an optimal balance of efficacy and safety. During the expansion phase (ie, after optimization of dose), additional patients with PV or ET were enrolled to receive Ruxolitinib at the dose that was selected upon review of data from the dose-ranging phase. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent. Study Design Go to Layout table for study information Study (...) with normal differential and platelets < 400 x 10^9/L No sustained leucopenia or thrombocytopenia (>2 weeks) No systemic PV symptoms (pruritus, night sweats, bone pain, fever, weight loss) PR: Hematocrit < 45% in men and < 42% in women 50% reduction in phlebotomy requirements from 6 months before treatment started 50% reduction in palpable splenomegaly Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR) [ Time Frame: Assessed

2008 Clinical Trials

125318. Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCV

is deemed necessary, an additional cohort at a lower dose (5 mg) may be enrolled: Cohort 4: GS 9450 5 mg or placebo given daily x 14 days Each cohort will be conducted sequentially. Advancement to higher dose cohorts is dependent upon satisfactory safety and tolerability profiles of the preceding cohort as determined by Sponsor review (conducted in consultation with the Lead Investigator[s]). Progression to Cohort 4 (5 mg dose strength) will not require a safety review of Cohort 3 (80 mg dose strength (...) ); screening and randomization for Cohort 4 may begin immediately after fully enrolling Cohort 3. Alternatively, if a dose-response relationship is apparent in review of the blinded activity data from the first three cohorts, the final 5 mg cohort may be omitted. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 33 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider

2008 Clinical Trials

125319. A Relative Bioavailability Study of Quinine Sulfate Capsules 324mg

years of age at the time of dosing. Weight range will not exceed ±20% for height and body frame Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and human immunodeficiency virus (HIV) antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures Screening will include general observations, physical (...) examination, demographics, medical history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems Screening Procedures: Hematology: hematocrit, hemoglobin, white blood cell (WBC) count with differential, red blood cell (RBC) count, platelet count Clinical chemistry: serum creatinine, blood urea nitrogen

2008 Clinical Trials

125320. Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients

(NCT Number): Layout table for additonal information Responsible Party: Ching-yi Wu, Professor, Chang Gung Memorial Hospital ClinicalTrials.gov Identifier: Other Study ID Numbers: NSC97-2314-B-182-004-MY3 96-1754B ( Other Identifier: Institutional Review Board / Chang Gung Memorial Hospital ) First Posted: October 23, 2008 Last Update Posted: August 2, 2012 Last Verified: July 2012 Keywords provided by Ching-yi Wu, Chang Gung Memorial Hospital: stroke rehabilitation kinematic analysis upper (...) extremity training predictors Additional relevant MeSH terms: Layout table for MeSH terms Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases

2008 Clinical Trials

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