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7481. Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer

: January 18, 2013 Sponsor: David M. Brizel, MD Collaborators: Genentech, Inc. OSI Pharmaceuticals Information provided by (Responsible Party): David M. Brizel, MD, Duke University Study Details Study Description Go to Brief Summary: Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment (...) , United States, 27710 Sponsors and Collaborators David M. Brizel, MD Genentech, Inc. OSI Pharmaceuticals Investigators Layout table for investigator information Principal Investigator: David M Brizel, MD Department of Radiation Oncology; Duke University Medical Center More Information Go to Publications of Results: Other Publications: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Layout table for additonal information Responsible Party: David M. Brizel

2005 Clinical Trials

7482. Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.

more. Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children. 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: NCT00140088 Recruitment Status : Completed First Posted : September 1, 2005 Last Update Posted : September 1, 2005 Sponsor: AlgoRx Pharmaceuticals Information provided (...) by: AlgoRx Pharmaceuticals Study Details Study Description Go to Brief Summary: Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free product that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III, prospective, randomized, double-blind, placebo-controlled study

2005 Clinical Trials

7483. A Double-blind, Placebo Controlled Trial of Risperidone for the Treatment of Anorexia Nervosa

Posted : February 2, 2016 Sponsor: University of Colorado, Denver Collaborators: Janssen Pharmaceuticals National Center for Research Resources (NCRR) Information provided by (Responsible Party): University of Colorado, Denver Study Details Study Description Go to Brief Summary: The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa. Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image distortion (...) calculates the difference between their actual image and the size of the image they have adjusted the digital image to based on their perception of "how they see themselves right now" Body Image Software (BIS): Average Desired Thinness [ Time Frame: monthly ] Body Image Software (BIS) - the subject adjusts a digital image of themselves on the computer to "their desired image". The BIS program calculates the difference between their actual image, and how much they have adjusted the image to represent

2005 Clinical Trials

7484. A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved. Number of Participants Who Achieved an MCR in The ITT Population [ Time Frame: From Weeks 24 to 52 ] The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted (...) Antirheumatic Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antipyretics Sleep Aids, Pharmaceutical Hypnotics and Sedatives Central Nervous System Depressants Anesthetics, Local Anesthetics Antiemetics

2005 Clinical Trials

7485. Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder

: September 16, 2005 Last Update Posted : October 5, 2011 Sponsor: University of Florida Collaborator: Ortho-McNeil Pharmaceutical Information provided by (Responsible Party): University of Florida Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if a drug called topiramate is safe and effective as an add-on therapy in the treatment of Obsessive-Compulsive Disorder (OCD). Topiramate is an investigational drug for OCD, which means it has not been approved (...) ). Subjects known to have clinically significant medical conditions, including but not limited to: symptomatic coronary artery or peripheral vascular disease malignancy or history of malignancy within the past 5 years, except basal cell carcinoma; any disease or condition that compromises the function of those body systems that could result in altered absorption, excess accumulation or impaired metabolism or excretion of topiramate; subjects who are considered to represent a significant risk of suicidal

2005 Clinical Trials

7486. A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients.

Posted : September 5, 2005 Last Update Posted : September 5, 2005 Sponsor: Mylan Bertek Pharmaceuticals Information provided by: Mylan Bertek Pharmaceuticals Study Details Study Description Go to Brief Summary: APO303 is a sub-study of patients enrolled in APO401 (the long-term open label safety protocol) and was designed to evaluate adverse events, particularly blood pressure drops when standing up during first dose in patients who have not been exposed to apomorphine before. Condition or disease (...) Intervention/treatment Phase Parkinson Disease Drug: apomorphine HCl injection Phase 3 Detailed Description: The primary objective of this study was to determine the electrocardiographic and orthostatic effects of apomorphine during controlled in-patient dose introduction in apomorphine-naïve late stage Parkinson’s disease patients. Although safety observations represented the primary objective of the study, a control group was considered essential to properly interpret adverse events that occurred during

2005 Clinical Trials

7487. Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures.

before adding more. Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures. 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: NCT00146185 Recruitment Status : Completed First Posted : September 7, 2005 Last Update Posted : November 16, 2005 Sponsor: AlgoRx Pharmaceuticals (...) Information provided by: AlgoRx Pharmaceuticals Study Details Study Description Go to Brief Summary: Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free product that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III, prospective, randomized, double-blind, placebo

2005 Clinical Trials

7488. Pentostatin for High Risk and Refractory Chronic Graft Versus Host Disease in Children

Children's Hospital of Chicago Collaborator: Astex Pharmaceuticals Information provided by: Ann & Robert H Lurie Children's Hospital of Chicago Study Details Study Description Go to Brief Summary: This is a multicenter trial through the Pediatric Blood and Marrow Transplant Consortium. The Primary hypothesis of this study is that because of its effect as a potent immunosuppressive agent targeting lymphocytes, pentostatin will show a sustained response in pediatric subjects with severe chronic GVHD (...) biopsy then a photograph documenting the skin and abnormal ROM studies may be submitted instead. If current GVHD represents the same episode which was previously biopsied, then a new biopsy is not necessary. If the previous biopsy was for an episode that went into remission and this is a new episode of GVHD, then a new biopsy is necessary. To be eligible for this portion of the study, a patient's chronic GVHD can be extensive or limited, as defined below: All subjects with extensive chronic GVHD

2005 Clinical Trials

7489. A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

Recruitment Status : Completed First Posted : July 1, 2005 Results First Posted : March 20, 2009 Last Update Posted : December 19, 2011 Sponsor: Ferring Pharmaceuticals Information provided by (Responsible Party): Ferring Pharmaceuticals Study Details Study Description Go to Brief Summary: The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment (...) and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values. 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

2005 Clinical Trials

7490. Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis

groups. Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns. Secondary Outcome Measures : Proportion of Participants With a Pa Positive Culture [ Time Frame: Week 10 (after initial treatment course for Pa) through Month 18 ] Proportion of participants with a Pa positive culture compared between (1) the pooled cycled therapy group (n=152) and pooled culture-based therapy group (n=152), and (2) between the pooled oral placebo (n (...) ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups. Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns. 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

2004 Clinical Trials

7491. A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

and liver transplant. Number of Participants With Adverse Events Leading to Dose Interruption or Modification [ Time Frame: Up to Week 26 ] An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported. Number of Participants (...) With Opportunistic Infections [ Time Frame: Up to Week 26 ] Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported. Number of Participants With Any Adverse Events and Any Serious Adverse Events [ Time Frame: Up to Week 26 ] An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical

2004 Clinical Trials

7492. Study of GPX-100 in the Treatment of Metastatic Breast Cancer

of Metastatic Breast Cancer 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: NCT00123877 Recruitment Status : Terminated First Posted : July 26, 2005 Last Update Posted : January 9, 2007 Sponsor: Gem Pharmaceuticals Information provided by: Gem Pharmaceuticals Study Details Study Description Go to Brief Summary (...) . The patient or a legally authorized representative must fully understand all elements of the informed consent and have signed the informed consent according to institutional and federal regulatory requirements. Exclusion Criteria: Patient is male. Patient is pregnant or breast-feeding. Patient has a history of hypersensitivity to anthracyclines. Patient has received a cumulative dose of doxorubicin that exceeds 300 mg/m2 or a cumulative dose of epirubicin that exceeds 540 mg/m2. Patient has received

2005 Clinical Trials

7493. C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema

concentrate to reverse angioedema. Signed informed consent by patient and patient's legal representative if under 18 years old Exclusion Criteria: Exclusion criteria for HAE type I and type II patients: Presence of clinically-relevant anti-C1 inhibitor auto-antibodies Participation in another pharmaceutical clinical study, which can interfere with this study, in the last 3 months prior to the study, other than Part A of this protocol. Addiction to narcotic/pain medication in case of an abdominal attack B (...) infusion. An attack is defined as moderate if it affects the normal daily activities of the patient in any way. Severe attacks are defined by the inability to perform normal daily activities. Signed informed consent by patient and patient's legal representative if under 18 years old Inclusion criteria for acquired angioedema patients: Established diagnosis of acquired angioedema: recurrent attacks of angioedema without urticaria; no family history; decreased functional C1 inhibitor; decreased level

2005 Clinical Trials

7494. Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Posted : April 11, 2012 Sponsor: Novartis Pharmaceuticals Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals ) Study Details Study Description Go to Brief Summary: Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple (...) for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria Evidence of myeloma according to the criteria of the British Columbia Cancer Agency (for the diagnosis, 2 of the 3 criteria must be met): Evidence of paraprotein in the serum or urine Bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells Radiologically, at least one osteolytic lesion Asymptomatic patients with Stage I (Durie

2005 Clinical Trials

7495. An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

) for glucose during a MCT baseline to week 20. Change in Insulin Sensitivity Index as Measured by M-value. [ Time Frame: Week 20 ] Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20. Change in Insulin AUC in the First Stage From Baseline to Endpoint. [ Time Frame: Week 20 ] Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp (...) test. Change in Insulin iAUC From Baseline to Endpoint. [ Time Frame: Week 20 ] Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test. Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT). [ Time Frame: Week 20 ] Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml

2005 Clinical Trials

7496. C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema

Volunteers: No Criteria Inclusion Criteria: Inclusion criteria for hereditary angioedema patients: Established diagnosis of hereditary angioedema type I or II: markedly decreased C1 inhibitor activity; decreased (type I), normal or elevated (type II) level of C1 inhibitor antigen; decreased level of C4. Patients already using C1 inhibitor concentrate for prophylaxis of angioedema attacks. Age ≥ 16 years Signed informed consent by patient and patient's legal representative if under 18 years old Inclusion (...) criteria for acquired angioedema patients: Established diagnosis of acquired angioedema: recurrent attacks of angioedema without urticaria; no family history; decreased functional C1 inhibitor; decreased level of C4. Autoantibodies to C1 inhibitor or decreased C1q or onset after the third decade of life. Age ≥ 16 years Patient already using C1 inhibitor concentrate for prophylaxis of angioedema attacks Signed informed consent by patient and patient's legal representative if under 18 years old Exclusion

2005 Clinical Trials

7497. Aripiprazole in Children and Adolescents With Bipolar I Disorder

and Adolescents With Bipolar I Disorder 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: NCT00110461 Recruitment Status : Completed First Posted : May 10, 2005 Results First Posted : May 21, 2012 Last Update Posted : May 21, 2012 Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Information (...) provided by: Otsuka Pharmaceutical Development & Commercialization, Inc. Study Details Study Description Go to Brief Summary: The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features. Condition or disease Intervention/treatment Phase Bipolar Disorder Drug: Aripiprazole Drug: placebo Phase 3 Study Design Go to Layout table for study information Study Type

2005 Clinical Trials

7498. VELCADE/Melphalan/Prednisone Versus Melphalan/Prednisone in Patients With Previously Untreated Multiple Myeloma

Update Posted : March 26, 2009 Sponsor: Millennium Pharmaceuticals, Inc. Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Information provided by: Millennium Pharmaceuticals, Inc. Study Details Study Description Go to Brief Summary: The primary reason for this study is to determine whether the addition of VELCADE (bortezomib) for injection to standard melphalan/prednisone (MP) therapy improves the time to disease progression (TTP) in subjects with previously untreated (...) multiple myeloma. Condition or disease Intervention/treatment Phase Multiple Myeloma Drug: bortezomib Phase 3 Expanded Access : Millennium Pharmaceuticals, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment

2005 Clinical Trials

7499. Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH)

Posted : May 18, 2005 Last Update Posted : July 10, 2018 Sponsor: Idorsia Pharmaceuticals Ltd. Information provided by (Responsible Party): Idorsia Pharmaceuticals Ltd. Study Details Study Description Go to Brief Summary: The purpose of the study is to measure how effective and safe three different doses of the drug clazosentan are in preventing vasospasm after subarachnoid hemorrhage. Condition or disease Intervention/treatment Phase Aneurysmal Subarachnoid Hemorrhage Drug: Clazosentan 1 mg/h Drug (...) the patient or a legal representative prior to initiation of any study-related procedure and enrollment Exclusion criteria: Patients with SAH due to other causes (e.g., trauma or rupture of fusiform or mycotic aneurysms) Patients with intraventricular or intracerebral blood, in the absence of subarachnoid blood No visualized clot or presence of only localized thin clot on CT (< 20 mm x 4 mm) Presence of any degree of cerebral vasospasm on screening angiogram Patients with hypotension (systolic blood

2005 Clinical Trials

7500. Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)

: Completed First Posted : February 25, 2004 Results First Posted : July 29, 2010 Last Update Posted : July 19, 2013 Sponsor: Cephalon Information provided by: Teva Pharmaceutical Industries Study Details Study Description Go to Brief Summary: The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean (...) , 1100, 1300, and 1500) assessed at the last postbaseline observation. Clinical Global Impression of Change (CGI-C) [ Time Frame: change from baseline at 12 weeks ] The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much

2004 Clinical Trials

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