FEATURE_phases list | FEATURE_enrollmentCount int64 | FEATURE_allocation string | FEATURE_interventionModel string | FEATURE_primaryPurpose class label | FEATURE_masking class label | FEATURE_healthyVolunteers bool | FEATURE_sex class label | FEATURE_oversightHasDmc bool | FEATURE_briefSummary string | FEATURE_detailedDescription string | FEATURE_conditions string | FEATURE_conditionsKeywords string | FEATURE_protocolPdfText string | FEATURE_numArms int64 | FEATURE_armDescriptions string | FEATURE_armGroupTypes list | FEATURE_numInterventions int64 | FEATURE_interventionTypes list | FEATURE_interventionDescriptions string | FEATURE_interventionNames string | FEATURE_numLocations int64 | FEATURE_locationDetails string | LABEL_ct_level_ade_population int64 | LABEL_sum_dosing_errors int64 | LABEL_dosing_error_rate float32 | LABEL_wilson_label int64 | METADATA_nctId string | METADATA_overallStatus class label | METADATA_completionDate date32 | METADATA_startDate date32 | METADATA_leadSponsorName string | METADATA_leadSponsorClass class label | METADATA_hasProtocol bool | METADATA_hasSap bool | METADATA_hasIcf bool | METADATA_protocolPdfLinks string | METADATA_count_Accidental drug intake by child int64 | METADATA_count_Accidental overdose int64 | METADATA_count_Accidental overdose (therapeutic agent) int64 | METADATA_count_Accidental underdose int64 | METADATA_count_Deliberate overdose int64 | METADATA_count_Dose calculation error int64 | METADATA_count_Drug administration error int64 | METADATA_count_Drug overdose int64 | METADATA_count_Drug overdose accidental int64 | METADATA_count_Extra dose administered int64 | METADATA_count_Incorrect dosage administered int64 | METADATA_count_Incorrect dose administered int64 | METADATA_count_Incorrect drug administration duration int64 | METADATA_count_Incorrect drug administration rate int64 | METADATA_count_Incorrect product administration duration int64 | METADATA_count_Intentional overdose int64 | METADATA_count_Medication error int64 | METADATA_count_Medication monitoring error int64 | METADATA_count_Multiple drug overdose int64 | METADATA_count_Multiple drug overdose accidental int64 | METADATA_count_Multiple drug overdose intentional int64 | METADATA_count_Multiple use of single-use product int64 | METADATA_count_Non-accidental overdose int64 | METADATA_count_Overdose int64 | METADATA_count_Overdose NOS int64 | METADATA_count_Overmedication int64 | METADATA_count_Prescribed overdose int64 | METADATA_count_Treatment noncompliance int64 | METADATA_count_Underdose int64 | METADATA_count_Unintentional medical device removal int64 | METADATA_count_Unintentional medical device removal by patient int64 | METADATA_wilson_lower_bound float32 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 58 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied. | null | Metastatic Pancreatic Cancer | null | 1 | arm 1: All participants were administered ixabepilone at a starting dose of 32 mg/m\^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m\^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m\^2 IV over 1 hour). | [
0
] | 2 | [
0,
0
] | intervention 1: Intravenous Infusion (IV), 32 mg/m\^2 every 21 days. intervention 2: Initial dose of 400 mg/m\^2 intravenous (IV) over 2 hours) followed by a weekly lower dose of 250 mg/m\^2 IV over 1 hour. | intervention 1: Ixabepilone intervention 2: Cetuximab | 9 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Detroit | Michigan | United States | -83.04575 | 42.33143
Columbia | Missouri | United States | -92.33407 | 38.95171
Greenville | South Carolina | United States | -82.39401 | 34.85262
Seattle | Washington | United States | -122.33207 | 47.60621
Morgantown | West Virginia | United States | -79.9559 | 39.62953 | 54 | 0 | 0 | 0 | NCT00383149 | 1COMPLETED | 2009-06-01 | 2007-01-01 | R-Pharm | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 47 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study, conducted at the NIH and the Mount Sinai School of Medicine, will examine the effectiveness of a substance P or NK1 antagonist study drug known as GR205171 in treating the symptoms of posttraumatic stress disorder (PTSD).
People between 18 and 65 years of age who have been diagnosed with PTSD may be eligible for this study. Participants undergo the following tests and procedures:
Treatment: Patients are tapered off current ineffective medications over 1 to 2 weeks. All participants receive placebo (sugar pill) at the start of the study. At some point within the first 3 weeks of the study, they are then randomly assigned either to take GR205171 or to continue with placebo for the remainder of the 10-week treatment period.
Clinic visits: Patients come to the clinic once a week during treatment. The following procedures are done at various visits.
* Interviews, self report questionnaires and psychiatric rating scales at every visit.
* Physical examination, blood and urine tests. Blood is drawn up to 10 times during the study.
Follow-up visits continue for up to 3 months after the end of the study, during which patients are offered standard clinical treatment. | Posttraumatic Stress Disorder (PTSD) is a common chronic anxiety disorder that is often debilitating and follows exposure to an overwhelming traumatic event. The burden of PTSD on individuals and society is significant. The majority of PTSD sufferers also meet the diagnostic criteria for several other psychiatric disorders and many attempt suicide. Despite the devastating impact of PTSD on the lives of millions worldwide, little is known about the etiology or pathophysiology of this disorder. Although disruptions in the hypothalamic-pituitary adrenal (HPA) Axis, noradrenergic, serotonergic systems have been proposed as neurobiological substrates in the development of PTSD, the exact underpinnings of the neurobiology of PTSD remain to be fully elucidated.
PTSD is responsive to treatment with selective serotonin reuptake inhibitors, but response rates rarely exceed 60%, and even fewer patients (20%-30%) experience improvement that could be characterized as remission. Thus, there is a clear need to develop novel and improved therapeutics for PTSD. A growing body of preclinical evidence suggests that activation of the Substance P (SP) and its receptor NK1 is anxiogenic and that NK1 antagonists, upon chronic administration, exert significant dampening (albeit complex) effects on the SP-NP system. Furthermore, several stress paradigms are believed to exert many of their deleterious effects on hippocampal structures via enhancement of SP-NK1 system. Overall, excess activity of the SP-NK1 system stands as a prime candidate for involvement in the pathophysiology of anxiety disorders such as PTSD.
In this study, we propose to investigate the potential antianxiety efficacy of the highly specific NK1 antagonist GR205171 in PTSD. Furthermore, we propose to, in a preliminary fashion, longitudinally investigate whether neuroendocrine surrogate markers are predictive of treatment response.
This is an 8-week double-blind placebo-controlled study that will examine the efficacy and safety of an NK1 antagonist in patients with PTSD.
Patients, ages 18 to 65 years with a diagnosis of PTSD, will in this pilot study be randomized to double-blind treatment to receive either the NK1 antagonist, GR205171 (5 mg/day) or placebo for a period of 8 weeks.
Approximately 52 patients will enter the study to obtain 40 subjects who complete the 8 weeks of acute NK1 antagonist treatment. | PTSD | PTSD Substance P Treatment Study Placebo Controlled Post Traumatic Stress Disorder | null | 2 | arm 1: selective neurokinin-1 receptor antagonist, fixed 5 mg dose every day, for 8 weeks. arm 2: sugar pill | [
0,
2
] | 9 | [
0,
3,
3,
3,
3,
3,
3,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None | intervention 1: NK1 Antagoist (GR205171) intervention 2: Psychophysiology (Trauma Script) intervention 3: Psychophysiology (Verbal Threat) intervention 4: Psychophysiology (Fear Conditioning) intervention 5: Psychophysiology (Affective Modulation) intervention 6: Psychophysiology (Heart rate variability) intervention 7: Lumbar Puncture intervention 8: 24-hour plasma sampling intervention 9: MRI | 2 | Bethesda | Maryland | United States | -77.10026 | 38.98067
New York | New York | United States | -74.00597 | 40.71427 | 47 | 0 | 0 | 0 | NCT00383786 | 1COMPLETED | 2009-06-01 | 2006-09-01 | Baylor College of Medicine | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Third molar surgery is complicated by pain and swelling for several days after surgery. Non-steroidal antiinflammatory drugs have been useful in combination with opioids for treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine or placebo as a nasal spray before surgery to determine whether nicotine affects pain or inflammation. | This is a randomized double blind cross-over study. In each of two sittings, the third molars on one side of the mouth are removed. In one sitting the subject will receive a nicotine nasal spray (3mg) and in the other placebo. VAS and narcotic utilization will be compared within patients. | Dental Crowding | Third Molar Pain | null | 2 | arm 1: In one sitting the subject will receive a nicotine nasal spray, 3 mg, one application. arm 2: In one sitting the subject will receive a placebo nasal spray (0 mg), one application. | [
1,
2
] | 2 | [
0,
10
] | intervention 1: Nicotine nasal spray 3mg x 1 before surgery intervention 2: Placebo nasal spray 0mg x 1 before surgery | intervention 1: Nicotine intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 40 | 0 | 0 | 0 | NCT00385216 | 1COMPLETED | 2009-06-01 | 2004-07-01 | Columbia University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 102 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC). | null | Small Cell Lung Cancer | SCLC SALUTE Lung Cancer Avastin | null | 2 | arm 1: Chemotherapy = cisplatin (or carboplatin) + etoposide arm 2: Chemotherapy = cisplatin (or carboplatin) + etoposide | [
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. intervention 2: Chemotherapy = cisplatin (or carboplatin) + etoposide. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve \[AUC\]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles. intervention 3: Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. | intervention 1: Bevacizumab intervention 2: Chemotherapy intervention 3: Placebo | 0 | null | 98 | 0 | 0 | 0 | NCT00403403 | 1COMPLETED | 2009-06-01 | 2007-03-01 | Genentech, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 233 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period. | null | Cervical Dystonia | null | 3 | arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 240 units, total volume 4.8mL; Mode of administration: intramuscular injection arm 2: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 120 units, total volume 4.8 mL; Mode of administration: intramuscular injection arm 3: Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 4.8 mL; Mode of administration: intramuscular injection | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units) intervention 2: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units) intervention 3: Placebo | intervention 1: incobotulinumtoxinA (Xeomin) (240 Units) intervention 2: incobotulinumtoxinA (Xeomin) (120 Units) intervention 3: Placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 233 | 0 | 0 | 0 | NCT00407030 | 1COMPLETED | 2009-06-01 | 2006-07-01 | Merz Pharmaceuticals GmbH | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 85 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to compare the safety and efficacy of treating individuals with acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom onset), to standard medical treatment. | Stroke is the third leading cause of death and the leading cause of disability in the United States. Ischemic stroke is caused by a blockage of blood flow to one or more brain arteries, usually due to a blood clot. As a result there is a reduced supply of oxygen and other nutrients leading to permanent brain damage. Normobaric oxygen therapy (NBO, or high-flow oxygen delivered via a facemask) shows promise as a simple, widely accessible, low-cost therapy that can prevent stroke-related brain damage and extend the time window for administering the clot-busting drug t-PA (tissue plasminogen activator), which is the only acute stroke treatment approved by the Food and Drug Administration.
The primary goal of this trial is to compare the safety and therapeutic efficacy of NBO (started within 9 hours of symptom onset) to standard medical treatment with Room Air. We aim to enroll a total of 240 individuals with acute ischemic stroke less than 9 hours after symptom onset, at the Massachusetts General and Brigham and Women's Hospitals in Boston. Participants will be randomly selected to receive either room air (RA, control) or NBO (active treatment) at flow rates of 30-45L/min administered via a face mask for 8 hours. Neurological function scores and neuroimaging \[magnetic resonance imaging (MRI) or computed tomography (CT) scans\] will be obtained before, during, and after therapy until 90 days.
This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit individuals with stroke. | Ischemic Stroke | ischemic stroke normobaric oxygen therapy | null | 2 | arm 1: Oxygen, inhaled at 30-45L/min via a facemask for 8 hours arm 2: Room Air, inhaled at 30-45L/min via a facemask for 8 hours | [
1,
2
] | 2 | [
0,
0
] | intervention 1: High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours. intervention 2: Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours. | intervention 1: NBO (Normobaric Oxygen) intervention 2: Room Air | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 84 | 0 | 0 | 0 | NCT00414726 | 6TERMINATED | 2009-06-01 | 2007-01-01 | Massachusetts General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 239 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer.
PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy. | OBJECTIVES:
Primary
* Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response.
Secondary
* Compare the effect of these regimens on the mean hemoglobin increment measured weekly from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal to 10.5 g/dL.
* Compare the time required to achieve hemoglobin levels within the goal range 11.0-12.0 g/dL in patients treated with these regimens.
* Compare the effect of these regimens on the proportion of patients requiring red blood cell transfusions and on the number of transfusions required.
* Compare the weekly change in hemoglobin in patients treated with these regimens.
* Compare the need for dose reduction in patients treated with these regimens.
* Compare the adverse event profiles of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, unblinded, pilot study. Patients are stratified according to severity of anemia (mild \[hemoglobin ≥ 9.5 g/dL\] vs severe \[hemoglobin \< 9.5 g/dL\]), platinum-containing regimen (yes vs no), and tumor type (nonmyeloid hematologic malignancy vs solid tumor). Patients are randomized to 1 of 4 treatment arms.
* Arm I: Patients receive epoetin alfa subcutaneously (SC) on day 1. Treatment repeats weekly for up to 15 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm I). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm II). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.
* Arm IV: Patients receive darbepoetin alfa SC on day 1. Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug dose is administered. Drug dosing is adjusted (e.g., held, reduced, resumed at a lower dose) as needed to maintain hemoglobin values within the desired ranges.
Quality of life is assessed at baseline and at weeks 4, 7, 10, 13, and 16.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study. | Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Unspecified Adult Solid Tumor, Protocol Specific | unspecified adult solid tumor, protocol specific extramedullary plasmacytoma isolated plasmacytoma of bone refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma Waldenstrom macroglobulinemia post-transplant lymphoproliferative disorder stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma adult grade III lymphomatoid granulomatosis stage I adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II marginal zone lymphoma noncontiguous stage II small lymphocytic lymphoma contiguous stage II adult Burkitt lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult lymphoblastic lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma contiguous stage II mantle cell lymphoma contiguous stage II marginal zone lymphoma contiguous stage II small lymphocytic lymphoma stage I adult diffuse large cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse small cleaved cell lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage I adult immunoblastic large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage I adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage I mantle cell lymphoma stage I marginal zone lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage I small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma adult acute lymphoblastic leukemia in remission recurrent adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia refractory hairy cell leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia anemia monoclonal gammopathy of undetermined significance primary systemic amyloidosis T-cell large granular lymphocyte leukemia acute undifferentiated leukemia mast cell leukemia adult nasal type extranodal NK/T-cell lymphoma untreated hairy cell leukemia | null | 4 | arm 1: 40,000 Units arm 2: 80,000 Units arm 3: 120,000 Units arm 4: 500 mcg | [
0,
0,
0,
0
] | 4 | [
0,
0,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: darbepoetin alfa intervention 2: epoetin alfa intervention 3: fatigue assessment and management intervention 4: quality-of-life assessment | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 234 | 0 | 0 | 0 | NCT00416624 | 1COMPLETED | 2009-06-01 | 2007-05-01 | Mayo Clinic | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 313 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | null | 0ALL | null | The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic. | null | Kidney Transplantation | Renal, Kidney, Intensified, Enteric-coated mycophenolate sodium, Transplant | null | 2 | arm 1: In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment. arm 2: In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440 mg/day had to be maintained throughout the whole study. | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment. intervention 2: cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels intervention 3: 20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day. | intervention 1: Enteric-coated mycophenolate sodium (Myfortic) intervention 2: Cyclosporine (Neoral) intervention 3: Prednisone | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 304 | 0 | 0 | 0 | NCT00419926 | 1COMPLETED | 2009-06-01 | 2006-12-01 | Novartis | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 108 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum) | null | Chalazion Hordeolum | null | 2 | arm 1: 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension arm 2: Vehicle | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. intervention 2: topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. | intervention 1: loteprednol etabonate/tobramycin opthalmic suspension intervention 2: vehicle | 1 | Erie | Pennsylvania | United States | -80.08506 | 42.12922 | 108 | 0 | 0 | 0 | NCT00420628 | 1COMPLETED | 2009-06-01 | 2006-11-01 | Bausch & Lomb Incorporated | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 281 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy. | null | Diabetic Nephropathy Chronic Kidney Disease | Type 2 Diabetic Nephropathy | null | 3 | arm 1: One paricalcitol 1 mcg capsule and one matching placebo capsule per dose arm 2: Two paricalcitol 1 mcg capsules per dose arm 3: Two placebo capsules per dose | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily) intervention 2: Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily) intervention 3: Group 1 - Placebo once daily (two placebo capsules once daily) | intervention 1: Zemplar (paricalcitol ) capsules intervention 2: Zemplar (paricalcitol) capsules intervention 3: Placebo | 72 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Fountain Valley | California | United States | -117.95367 | 33.70918
Yuba City | California | United States | -121.61691 | 39.14045
Hudson | Florida | United States | -82.69343 | 28.36445
Lauderdale Lakes | Florida | United States | -80.20838 | 26.16647
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Roswell | Georgia | United States | -84.36159 | 34.02316
Chicago | Illinois | United States | -87.65005 | 41.85003
Evanston | Illinois | United States | -87.69006 | 42.04114
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Rockville | Maryland | United States | -77.15276 | 39.084
Boston | Massachusetts | United States | -71.05977 | 42.35843
Brooklyn Center | Minnesota | United States | -93.33273 | 45.07608
Omaha | Nebraska | United States | -95.94043 | 41.25626
Albany | New York | United States | -73.75623 | 42.65258
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Greenville | North Carolina | United States | -77.36635 | 35.61266
Morehead City | North Carolina | United States | -76.72604 | 34.72294
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Carlisle | Pennsylvania | United States | -77.18887 | 40.20148
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Düsseldorf | N/A | Germany | 6.77616 | 51.22172
Hanover | N/A | Germany | 9.73322 | 52.37052
Ludwigshafen | N/A | Germany | 9.06138 | 47.81663
Athens | N/A | Greece | 23.72784 | 37.98376
Ioannina | N/A | Greece | 20.85189 | 39.66486
Thessaloniki | N/A | Greece | 22.93086 | 40.64361
Thessaloniki | N/A | Greece | 22.93086 | 40.64361
Bergamo | N/A | Italy | 9.66721 | 45.69601
Brescia | N/A | Italy | 10.21472 | 45.53558
Milan | N/A | Italy | 9.18951 | 45.46427
Modena | N/A | Italy | 10.92539 | 44.64783
Groningen | N/A | Netherlands | 6.56667 | 53.21917
Bydgoszcz | N/A | Poland | 18.00762 | 53.1235
Katowice | N/A | Poland | 19.02754 | 50.25841
Szczecin | N/A | Poland | 14.55302 | 53.42894
Warsaw | N/A | Poland | 21.01178 | 52.22977
Lisbon | N/A | Portugal | -9.1498 | 38.72509
Porto | N/A | Portugal | -8.61099 | 41.14961
Caguas | N/A | Puerto Rico | -66.0485 | 18.23412
Carolina | N/A | Puerto Rico | -65.95739 | 18.38078
Las Piedras | N/A | Puerto Rico | -65.86627 | 18.18301
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Rio Piedras | N/A | Puerto Rico | -66.04989 | 18.39745
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
Toa Baja | N/A | Puerto Rico | -66.25961 | 18.44384
Yabucoa | N/A | Puerto Rico | -65.87933 | 18.05052
Barcelona | N/A | Spain | 2.15899 | 41.38879
Galdakao | N/A | Spain | -2.8429 | 43.23073
L'Hospitalet de | N/A | Spain | N/A | N/A
Madrid | N/A | Spain | -3.70256 | 40.4165
Oviedo | N/A | Spain | -5.84476 | 43.36029
Santander | N/A | Spain | -3.80444 | 43.46472
Valencia | N/A | Spain | -0.37966 | 39.47391
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Xinzhuang | N/A | Taiwan | 120.3713 | 23.916 | 281 | 0 | 0 | 0 | NCT00421733 | 1COMPLETED | 2009-06-01 | 2006-12-01 | Abbott | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 573 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial. | The trial is a randomized, double blind, placebo controlled, parallel group trial in subjects diagnosed with fibromyalgia in accordance with the American College of Rheumatology. Total duration is up to twenty-two (22) weeks of trial participation. Subjects will undergo a screening and withdrawal/washout period lasting up to five (5) weeks combined followed by baseline period lasting one (1) week. Total treatment duration will be fourteen (14) weeks followed by a two week safety follow-up post treatment period. During the screening and withdrawal/washout period, no study medication will be given; however rescue medication up to 4 grams per day of acetaminophen (paracetemol) will be allowed. | Fibromyalgia | FMS Fibro pain Body pain tenderness stiffness muscular pain joint pain | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Oral Solution intervention 2: two doses | intervention 1: placebo intervention 2: Xyrem® | 116 | Auburn | Alabama | United States | -85.48078 | 32.60986
Birmingham | Alabama | United States | -86.80249 | 33.52066
Montgomery | Alabama | United States | -86.29997 | 32.36681
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Burbank | California | United States | -118.30897 | 34.18084
Fair Oaks | California | United States | -121.27217 | 38.64463
Fullerton | California | United States | -117.92534 | 33.87029
Irvine | California | United States | -117.82311 | 33.66946
Northridge | California | United States | -118.53675 | 34.22834
Pismo Beach | California | United States | -120.64128 | 35.14275
Sacramento | California | United States | -121.4944 | 38.58157
Sacramento | California | United States | -121.4944 | 38.58157
Farmington | Connecticut | United States | -72.83204 | 41.71982
Gainesville | Florida | United States | -82.32483 | 29.65163
Jacksonville | Florida | United States | -81.65565 | 30.33218
Largo | Florida | United States | -82.78842 | 27.90979
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Tampa | Florida | United States | -82.45843 | 27.94752
Tavares | Florida | United States | -81.72563 | 28.80416
Vero Beach | Florida | United States | -80.39727 | 27.63864
Zephyrhills | Florida | United States | -82.18119 | 28.23362
Marietta | Georgia | United States | -84.54993 | 33.9526
Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Topeka | Kansas | United States | -95.67804 | 39.04833
Elizabethtown | Kentucky | United States | -85.85913 | 37.69395
Lexington | Kentucky | United States | -84.47772 | 37.98869
Owensboro | Kentucky | United States | -87.11333 | 37.77422
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Rockville | Maryland | United States | -77.15276 | 39.084
Benzonia | Michigan | United States | -86.09926 | 44.62139
Bingham Farms | Michigan | United States | -83.27326 | 42.51587
Cadillac | Michigan | United States | -85.40116 | 44.25195
Interlochen | Michigan | United States | -85.7673 | 44.64472
Hattiesburg | Mississippi | United States | -89.29034 | 31.32712
St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727
Omaha | Nebraska | United States | -95.94043 | 41.25626
Berlin | New Jersey | United States | -74.92905 | 39.79123
East Brunswick | New Jersey | United States | -74.41598 | 40.42788
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Valley Stream | New York | United States | -73.70846 | 40.66427
Westfield | New York | United States | -79.5781 | 42.32228
Boone | North Carolina | United States | -81.67455 | 36.21679
Greenville | North Carolina | United States | -77.36635 | 35.61266
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cleveland | Ohio | United States | -81.69541 | 41.4995
Columbus | Ohio | United States | -82.99879 | 39.96118
Middleburg Heights | Ohio | United States | -81.81291 | 41.36144
Portland | Oregon | United States | -122.67621 | 45.52345
Portland | Oregon | United States | -122.67621 | 45.52345
Beaver | Pennsylvania | United States | -80.30478 | 40.69534
Duncansville | Pennsylvania | United States | -78.4339 | 40.42341
Yardley | Pennsylvania | United States | -74.846 | 40.24566
Columbia | South Carolina | United States | -81.03481 | 34.00071
Austin | Texas | United States | -97.74306 | 30.26715
Fort Worth | Texas | United States | -97.32085 | 32.72541
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Sugarland | Texas | United States | N/A | N/A
Waco | Texas | United States | -97.14667 | 31.54933
Arlington | Virginia | United States | -77.10428 | 38.88101
Amiens | N/A | France | 2.3 | 49.9
Échirolles | N/A | France | 5.71441 | 45.14603
Lille | N/A | France | 3.05858 | 50.63297
Nantes | N/A | France | -1.55336 | 47.21725
Nice | N/A | France | 7.26608 | 43.70313
Paris | N/A | France | 2.3488 | 48.85341
Toulouse | N/A | France | 1.44367 | 43.60426
Berlin | N/A | Germany | 13.41053 | 52.52437
Böblingen | N/A | Germany | 9.01171 | 48.68212
Cologne | N/A | Germany | 6.95 | 50.93333
Essen | N/A | Germany | 7.01228 | 51.45657
Gräfelfing | N/A | Germany | 11.42939 | 48.11878
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hohenfelde - Bad Doberan | N/A | Germany | N/A | N/A
Mannheim | N/A | Germany | 8.46694 | 49.4891
Schwalmtal | N/A | Germany | 6.26667 | 51.21667
Milan | N/A | Italy | 12.59836 | 42.78235
Pisa | N/A | Italy | 10.4036 | 43.70853
Breda | N/A | Netherlands | 4.77596 | 51.58656
Enschede | N/A | Netherlands | 6.89583 | 52.21833
Elblag | N/A | Poland | 19.40884 | 54.1522
Katowice | N/A | Poland | 19.02754 | 50.25841
Poznan | N/A | Poland | 16.92993 | 52.40692
Szczecinie | N/A | Poland | N/A | N/A
Torun | N/A | Poland | 18.59814 | 53.01375
Warsaw | N/A | Poland | 21.01178 | 52.22977
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Guadalajara | N/A | Spain | -3.16185 | 40.62862
Las Palmas de Gran Canaria | N/A | Spain | -15.41343 | 28.09973
Málaga | N/A | Spain | -4.42034 | 36.72016
Oviedo | N/A | Spain | -5.84476 | 43.36029
San Cristóbal de La Laguna | N/A | Spain | -16.32014 | 28.4853
Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052
Barnsley | N/A | United Kingdom | -1.48333 | 53.55
Bath | N/A | United Kingdom | -2.36172 | 51.3751
Bolton | N/A | United Kingdom | -2.43333 | 53.58333
London | N/A | United Kingdom | -0.12574 | 51.50853
London | N/A | United Kingdom | -0.12574 | 51.50853
London | N/A | United Kingdom | -0.12574 | 51.50853
Newcastle | N/A | United Kingdom | -5.88979 | 54.21804
Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328
Poole | N/A | United Kingdom | -1.98458 | 50.71429
Poole | N/A | United Kingdom | -1.98458 | 50.71429 | 571 | 0 | 0 | 0 | NCT00423813 | 1COMPLETED | 2009-06-01 | 2006-12-01 | Jazz Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 57 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the maximum tolerated dose and recommended phase 2 dose of PF-03814735 administered orally as single agent in patients with advanced solid tumors. | null | Solid Tumors | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity. | intervention 1: PF-03814735 | 2 | Nashville | Tennessee | United States | -86.78444 | 36.16589
Leuven | N/A | Belgium | 4.70093 | 50.87959 | 57 | 0 | 0 | 0 | NCT00424632 | 1COMPLETED | 2009-06-01 | 2006-11-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 25 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with docetaxel works in treating patients with recurrent or metastatic head and neck cancer. | OBJECTIVES:
Primary
* Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with bortezomib and docetaxel.
Secondary
* Determine the time to progression in patients treated with this regimen.
* Determine the toxicity of this regimen.
* Determine the duration of response in patients treated with this regimen.
* Determine the overall survival and progression-free survival of these patients.
* Determine 20S proteasome inhibition in peripheral blood mononuclear cells (PBMC) from these patients.
* Determine the effect of bortezomib on NF-kB pathway in PBMC and serum samples.
* Identify biomarkers of clinical response to bortezomib and docetaxel in PBMC and serum.
* Determine quality of life, symptom burden, and physical function outcome in patients treated with this regimen.
OUTLINE: This is a prospective, open-label, nonrandomized study.
Patients receive docetaxel\* IV over 30 minutes and bortezomib IV on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
NOTE: \*Docetaxel is not administered on day 1 of course 1.
Blood samples are collected at baseline, after bortezomib administration on day 1 of course 1, and at the completion of treatment. The pharmacodynamics and pharmacogenomics of bortezomib are assessed in peripheral blood mononuclear cells (PBMC) and serum.
After completion of study treatment, patients are followed every 6 weeks for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study. | Head and Neck Cancer | stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx | null | 1 | arm 1: Docetaxel (40 mg/m2) IV Infusion over 30 minutes every 3 weeks (Day 1 and 8 of 21 day cycle)except the first dose is held on Day 1 of Cycle 1.
Bortezomib (1.6mg/m2) IV 3-5 second push every 3 weeks (Day 1 and 8 of 21 day cycle).Bortezomib is given as a single agent only on Day 1 of Cycle 1. | [
0
] | 4 | [
0,
0,
10,
10
] | intervention 1: 1.6 mg/m2 through a vein on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1. intervention 2: 40 mg/m2 through a vein on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. intervention 3: Tissue and blood collection. intervention 4: Blood collection. | intervention 1: bortezomib intervention 2: docetaxel intervention 3: laboratory biomarker analysis intervention 4: pharmacological study | 7 | Hopkinsville | Kentucky | United States | -87.49117 | 36.86561
Paducah | Kentucky | United States | -88.60005 | 37.08339
Crossville | Tennessee | United States | -85.0269 | 35.94896
Jackson | Tennessee | United States | -88.81395 | 35.61452
Knoxville | Tennessee | United States | -83.92074 | 35.96064
Nashville | Tennessee | United States | -86.78444 | 36.16589
Nashville | Tennessee | United States | -86.78444 | 36.16589 | 25 | 0 | 0 | 0 | NCT00425750 | 1COMPLETED | 2009-06-01 | 2005-08-01 | Vanderbilt-Ingram Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable. | Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.
Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL. | Lymphoma, Non-Hodgkin | Lymphoma, Non-Hodgkin, Low-Grade | null | 1 | arm 1: Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section | [
0
] | 2 | [
0,
0
] | intervention 1: starting with 60 mg/m\^ 2, IV, dose escalation, weekly d1,8,15 q5w intervention 2: weekly 1.5mg/m\^2, IV, d1,8,15,22 q5w | intervention 1: Bendamustine intervention 2: Bortezomib | 0 | null | 12 | 0 | 0 | 0 | NCT00426855 | 1COMPLETED | 2009-06-01 | 2007-01-01 | Peter Moosmann | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 15 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence. | This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT. | Substance-Related Disorders | cognitive-behavior therapy d-cycloserine cognitive enhancer drug dependence opiate dependence exposure isolated doses of d-cycloserine isolated doses of matching pill placebo DCS | null | 2 | arm 1: D-cycloserine-augmented CBT-IC arm 2: Placebo-augmented CBT-IC | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10) intervention 2: Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10) | intervention 1: D-cycloserine intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 10 | 0 | 0 | 0 | NCT00430573 | 6TERMINATED | 2009-06-01 | 2007-02-01 | Boston University Charles River Campus | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 803 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate glycemic control. | Despite the introduction of new classes of medications for glycemic control, just over half of adults with type 2 diabetes mellitus (T2DM) achieve a glycosylated hemoglobin level less than 7.0%, the American Diabetes Association recommended glycosylated hemoglobin goal. The rising incidence of type 2 diabetes mellitus along with limitations of the currently available treatments suggest the need for new therapies for glycemic control along with the increased requirement for combination therapy in type 2 diabetes mellitus.
Thiazolidinediones increase glucose utilization, decrease gluconeogenesis, and increase glucose disposal through an incompletely understood mechanism but one associated with binding of the drug to nuclear receptors known as peroxisome proliferator-activated receptors-gamma. Peroxisome proliferator-activated receptors-gamma are found in tissues important for insulin action, such as adipose tissue, skeletal muscle, and the liver. The greatest concentration of peroxisome proliferator-activated receptors-gamma receptors is in adipose tissue. Thiazolidinediones reduce insulin resistance by enhancing insulin sensitivity in muscle cells, adipose tissue, and hepatic cells (inhibiting hepatic gluconeogenesis) with no direct impact on insulin secretion. Thus, thiazolidinediones improve glycemic control and result in reduced levels of circulating insulin. Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone depends on the presence of insulin for its mechanism of action. Worldwide clinical investigation has shown that, as an adjunct to diet and exercise, pioglitazone improves glycemic control when used as monotherapy, and in combination with commonly used antidiabetic medications (ie, sulfonylureas, metformin, or insulin).
SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV currently in development by Takeda Global Research \& Development Center, Inc. as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. Both peptides exert important effects on islet β-cells to stimulate glucose-dependent insulin secretion and regulate β-cell proliferation and cytoprotection. Glucagon-like peptide-1 also inhibits gastric emptying, glucagon secretion, and food intake. The glucose-lowering actions of glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, are preserved in patients with type 2 diabetes.
Given the complementary mechanisms of action of alogliptin (stimulation of insulin secretion) and pioglitazone (enhancement of insulin sensitivity) and the absence of overlapping safety risks, the introduction of this combination therapy in patients with T2DM could potentially show enhanced glycemic control and allow patients to reach and maintain their HbA1c goal more effectively.
This study is designed to determine if the addition of alogliptin to a combination of pioglitazone with metformin can be effective at achieving glycemic control without increasing safety risks versus the titration of pioglitazone to 45 mg with metformin in patients with type 2 diabetes mellitus who are experiencing inadequate glycemic control on a current regimen of metformin. | Diabetes Mellitus | Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Hyperglycemia Drug Therapy | null | 2 | arm 1: Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks. arm 2: Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks. | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Alogliptin tablets. intervention 2: Pioglitazone tablets. intervention 3: Metformin HCl tablets (immediate-release, commercially available formulation) ≥1500 mg or maximum tolerated dose. intervention 4: Matching placebo tablets. | intervention 1: Alogliptin intervention 2: Pioglitazone intervention 3: Metformin intervention 4: Placebo | 86 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Lake Havasu City | Arizona | United States | -114.32245 | 34.4839
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Foothill Ranch | California | United States | -117.66088 | 33.68641
Los Alamitos | California | United States | -118.07256 | 33.80307
Los Angeles | California | United States | -118.24368 | 34.05223
Pismo Beach | California | United States | -120.64128 | 35.14275
San Diego | California | United States | -117.16472 | 32.71571
Golden | Colorado | United States | -105.2211 | 39.75554
Clearwater | Florida | United States | -82.8001 | 27.96585
Hialeah | Florida | United States | -80.27811 | 25.8576
Lakeland | Florida | United States | -81.9498 | 28.03947
Marianna | Florida | United States | -85.22687 | 30.77436
Miami | Florida | United States | -80.19366 | 25.77427
North Miami Beach | Florida | United States | -80.16255 | 25.93315
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Sebastian | Florida | United States | -80.47061 | 27.81641
South Miami | Florida | United States | -80.29338 | 25.7076
Tampa | Florida | United States | -82.45843 | 27.94752
Winter Park | Florida | United States | -81.33924 | 28.6
Blue Ridge | Georgia | United States | -84.32409 | 34.86397
Conyers | Georgia | United States | -84.01769 | 33.66761
Decatur | Georgia | United States | -84.29631 | 33.77483
Duluth | Georgia | United States | -84.14464 | 34.00288
Dunwoody | Georgia | United States | -84.33465 | 33.94621
Warner Robins | Georgia | United States | -83.62664 | 32.61574
Boise | Idaho | United States | -116.20345 | 43.6135
Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768
Burr Ridge | Illinois | United States | -87.91839 | 41.74892
Chicago | Illinois | United States | -87.65005 | 41.85003
Melrose Park | Illinois | United States | -87.85673 | 41.90059
Naperville | Illinois | United States | -88.14729 | 41.78586
O'Fallon | Illinois | United States | -89.91121 | 38.59227
Bloomington | Indiana | United States | -86.52639 | 39.16533
Mishawaka | Indiana | United States | -86.15862 | 41.66199
Overland Park | Kansas | United States | -94.67079 | 38.98223
Marrero | Louisiana | United States | -90.10035 | 29.89937
Elkton | Maryland | United States | -75.83327 | 39.60678
Rockville | Maryland | United States | -77.15276 | 39.084
Towson | Maryland | United States | -76.60191 | 39.4015
Marlborough | Massachusetts | United States | -71.55229 | 42.34593
Bay City | Michigan | United States | -83.88886 | 43.59447
Saint Clair Shores | Michigan | United States | -82.88881 | 42.49698
McCook | Nebraska | United States | -100.62571 | 40.20195
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Blackwood | New Jersey | United States | -75.06406 | 39.80234
Trenton | New Jersey | United States | -74.74294 | 40.21705
West Caldwell | New Jersey | United States | -74.29695 | 40.84852
Asheboro | North Carolina | United States | -79.81364 | 35.70791
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Mooresville | North Carolina | United States | -80.81007 | 35.58486
Shelby | North Carolina | United States | -81.53565 | 35.29235
Sparta | North Carolina | United States | -81.12092 | 36.50541
Bismarck | North Dakota | United States | -100.78374 | 46.80833
Orrville | Ohio | United States | -81.76402 | 40.84367
Norman | Oklahoma | United States | -97.43948 | 35.22257
Ashland | Oregon | United States | -122.70948 | 42.19458
Aliquippa | Pennsylvania | United States | -80.24006 | 40.63673
Altoona | Pennsylvania | United States | -78.39474 | 40.51868
Dawningtown | Pennsylvania | United States | N/A | N/A
Fleetwood | Pennsylvania | United States | -75.81798 | 40.45398
Kingston | Pennsylvania | United States | -75.89686 | 41.26175
Norristown | Pennsylvania | United States | -75.3399 | 40.1215
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Tipton | Pennsylvania | United States | -78.29585 | 40.6359
Florence | South Carolina | United States | -79.76256 | 34.19543
Taylors | South Carolina | United States | -82.29623 | 34.92039
Williamston | South Carolina | United States | -82.47791 | 34.61845
Watertown | South Dakota | United States | -97.11507 | 44.89941
Kingsport | Tennessee | United States | -82.56182 | 36.54843
Milan | Tennessee | United States | -88.75895 | 35.91979
Nashville | Tennessee | United States | -86.78444 | 36.16589
Arlington | Texas | United States | -97.10807 | 32.73569
Austin | Texas | United States | -97.74306 | 30.26715
Colleyville | Texas | United States | -97.15501 | 32.88096
El Paso | Texas | United States | -106.48693 | 31.75872
Garland | Texas | United States | -96.63888 | 32.91262
Houston | Texas | United States | -95.36327 | 29.76328
Hurst | Texas | United States | -97.17057 | 32.82346
San Antonio | Texas | United States | -98.49363 | 29.42412
Seguin | Texas | United States | -97.96473 | 29.56884
Hampton | Virginia | United States | -76.34522 | 37.02987
Norfolk | Virginia | United States | -76.28522 | 36.84681
Richmond | Virginia | United States | -77.46026 | 37.55376
Virginia Beach | Virginia | United States | -75.97799 | 36.85293 | 803 | 0 | 0 | 0 | NCT00432276 | 1COMPLETED | 2009-06-01 | 2007-01-01 | Takeda | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 61 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma. | null | Allergic Asthma | AQUA anti-CD11 CD11a Asthma Allergy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Aged Liquid; subcutaneous repeating dose intervention 2: Lyophilized; subcutaneous repeating dose intervention 3: Subcutaneous repeating dose | intervention 1: omalizumab intervention 2: omalizumab intervention 3: placebo | 0 | null | 61 | 0 | 0 | 0 | NCT00434434 | 1COMPLETED | 2009-06-01 | 2007-10-01 | Genentech, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 494 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks. | null | Type 2 Diabetes Mellitus | diabetes exenatide Byetta Amylin Lilly | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: subcutaneous injection (5 mcg or 10 mcg), twice a day intervention 2: subcutaneous injection (titrated appropriately), twice a day | intervention 1: exenatide twice daily (BID) intervention 2: premixed insulin aspart twice daily (BID) | 39 | Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925
Berlin | N/A | Germany | 13.41053 | 52.52437
Bosenheim | N/A | Germany | 7.91382 | 49.84472
Burghausen | N/A | Germany | 12.83139 | 48.16925
Datteln | N/A | Germany | 7.3453 | 51.65598
Dresden | N/A | Germany | 13.73832 | 51.05089
Essen | N/A | Germany | 7.01228 | 51.45657
Friedrichsthal | N/A | Germany | 7.09622 | 49.32786
Hildesheim | N/A | Germany | 9.95112 | 52.15077
Hirschhorn | N/A | Germany | 8.89594 | 49.44566
Hohenmölsen | N/A | Germany | 12.1 | 51.15769
Jena | N/A | Germany | 11.5899 | 50.92878
Lehrte | N/A | Germany | 9.97919 | 52.37193
Leipzig | N/A | Germany | 12.37129 | 51.33962
Ludwigsburg | N/A | Germany | 9.19161 | 48.89731
Mannheim | N/A | Germany | 8.46694 | 49.4891
Marburg | N/A | Germany | 8.77069 | 50.80904
Marktheidenfeld | N/A | Germany | 9.60359 | 49.8454
Meissen | N/A | Germany | 13.4737 | 51.16158
München | N/A | Germany | 13.31243 | 51.60698
Offenbach | N/A | Germany | 8.76647 | 50.10061
Oschatz | N/A | Germany | 13.10984 | 51.30001
Pohlheim | N/A | Germany | N/A | N/A
Regensburg | N/A | Germany | 12.10161 | 49.01513
Riesa | N/A | Germany | 13.29168 | 51.30777
Rodgau | N/A | Germany | 8.88588 | 50.02627
Roding | N/A | Germany | 12.51956 | 49.19426
Rosenheim | N/A | Germany | 12.12247 | 47.85637
Schlüchtern | N/A | Germany | 9.52532 | 50.34891
Schwedt | N/A | Germany | 14.28154 | 53.05963
Sinsheim | N/A | Germany | 8.87867 | 49.2529
Speyer | N/A | Germany | 8.43111 | 49.32083
Unterhaching | N/A | Germany | 11.61564 | 48.06598
Völklingen | N/A | Germany | 6.85873 | 49.25162
Wallerfing | N/A | Germany | 12.88035 | 48.68416
Wangen | N/A | Germany | 9.83247 | 47.6895
Warburg | N/A | Germany | 9.14641 | 51.49011
Wiesbaden | N/A | Germany | 8.24932 | 50.08258
Wolfsburg | N/A | Germany | 10.7815 | 52.42452 | 480 | 0 | 0 | 0 | NCT00434954 | 1COMPLETED | 2009-06-01 | 2007-02-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP). | This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationship of avatrombopag will also be studied. Approximately 65 eligible participants will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either avatrombopag 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each avatrombopag dosing group will consist of 15 participants while the placebo group will consist of 5 participants. All study participants will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and 28) avatrombopag PK while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose (Day 42).
At the completion of Visit Day 28±1, participants who complete 28±1 days of study dosing will be assessed for eligibility to enroll into the rollover Study 501-CL-004 (NCT00625443) based on this visit. | Chronic Idiopathic Thrombocytopenic Purpura Purpura, Thrombocytopenic, Idiopathic | Chronic Idiopathic Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura ITP | null | 2 | arm 1: 2.5, 5, 10 or 20 mg tablets
1 tablet taken orally once daily for 28 days arm 2: 2.5, 5, 10, or 20 mg tablets
1 tablet taken orally once daily for 28 days | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Placebo tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days. intervention 2: Avatrombopag tablets 2.5, 5, 10 and 20 mg taken orally once daily for 28 days. | intervention 1: Placebo intervention 2: Avatrombopag tablets | 25 | Anaheim | California | United States | -117.9145 | 33.83529
Bakersfield | California | United States | -119.01871 | 35.37329
Concord | California | United States | -122.03107 | 37.97798
Fountain Valley | California | United States | -117.95367 | 33.70918
Orange | California | United States | -117.85311 | 33.78779
Manchester | Connecticut | United States | -72.52148 | 41.77593
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
New Port Richey | Florida | United States | -82.71927 | 28.24418
Columbus | Georgia | United States | -84.98771 | 32.46098
Chicago | Illinois | United States | -87.65005 | 41.85003
Peoria | Illinois | United States | -89.58899 | 40.69365
New Albany | Indiana | United States | -85.82413 | 38.28562
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Jefferson City | Missouri | United States | -92.17352 | 38.5767
Kansas City | Missouri | United States | -94.57857 | 39.09973
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
High Point | North Carolina | United States | -80.00532 | 35.95569
Columbus | Ohio | United States | -82.99879 | 39.96118
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Greenville | South Carolina | United States | -82.39401 | 34.85262
Seattle | Washington | United States | -122.33207 | 47.60621 | 64 | 0 | 0 | 0 | NCT00441090 | 1COMPLETED | 2009-06-01 | 2007-02-01 | Eisai Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 30 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Participants with non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD) will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with granulocyte colony-stimulating factor (G-CSF) and plerixafor.
(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of rituximab beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF.
Participants in both groups will receive G-CSF twice daily for 4 days. In the evening on Day 4, a dose of plerixafor will be administered. Apheresis will be initiated the next morning. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5\*10\^6 CD34+ cells/kg are collected.
Participants who are transplanted will be monitored for the time to polymorphonuclear leukocytes (PMN), platelets (PLT), and lymphocyte engraftment. Follow-up assessments will be done at 100 days, and 6 and 12 months post-transplantation. | This is a single-center, 2-arm, non-randomized, open-label study to evaluate the safety of plerixafor when used in combination with rituximab (Rituxan®) and granulocyte colony-stimulating factor (G-CSF) in patients with relapsed or refractory Hodgkin disease (HD) or non-Hodgkin lymphoma (NHL).
Participants will be assigned to one of 2 arms based on the immunophenotype of their lymphoma.
(A)Participants with CD20(-) lymphoma will undergo mobilization with G-CSF and plerixafor.
(B) Participants with CD20(+) lymphomas will undergo mobilization with rituximab, G-CSF, and plerixafor. They will receive a weekly dose of 375 mg/m2 rituximab by intravenous (iv) infusion beginning 1 week prior to, and continuing until 2 weeks after, the first dose of G-CSF.
Participants in both groups will receive 7.5 µg/kg G-CSF twice daily (morning and evening) for 4 days. In the evening (approximately 10:00 pm) on Day 4, a dose of plerixafor (240 µg/kg) will be administered. Apheresis will be initiated the next morning, approximately 10 to 11 hours after plerixafor is given. Participants will continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the next morning for up to a total of 4 aphereses or until ≥5\*10\^6 CD34+ cells/kg are collected.
Participants with an adequate number of autologous peripheral blood stem cells (PBSCs) collected by apheresis will be admitted to the study center for the administration of high-dose chemotherapy and autologous transplantation. After transplantation, the times to PMN, PLT, and lymphocyte engraftment will be measured. Participants will remain hospitalized until they achieve an absolute granulocyte count of \>500/µl in the peripheral blood. Graft durability will be assessed at 100 days, and 6 and 12 months post-transplantation.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial. | Non-Hodgkin Lymphoma Hodgkin Disease | AMD3100 stem cell mobilization autologous transplant Non-Hodgkin Lymphoma Hodgkin Disease | null | 2 | arm 1: Participants with CD20- lymphoma arm 2: Participants with CD20+ lymphoma | [
0,
0
] | 3 | [
0,
0,
2
] | intervention 1: Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (sc) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected. intervention 2: Participants underwent mobilization with G-CSF (7.5 µg/kg twice daily) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received a dose of plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants returned to the clinic and received a morning dose of G-CSF (7.5 µg/kg) and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor. Participants were to continue to receive G-CSF twice daily and to receive the evening dose of plerixafor followed by apheresis the following morning for a maximum of 4 aphereses or until ≥5\*10\^6 CD34+ cells/kg were collected. intervention 3: Participants were given a weekly dose of rituximab 375mg/m2 by intravenous infusion for 1 week prior to and continuing until 2 weeks after the first dose of G-CSF. | intervention 1: G-CSF plus plerixafor intervention 2: G-CSF plus plerixafor intervention 3: rituximab | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 30 | 0 | 0 | 0 | NCT00444912 | 1COMPLETED | 2009-06-01 | 2006-02-01 | Genzyme, a Sanofi Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 32 | NA | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | false | This Phase 2a, multicenter, open-label, dose-escalation study is designed to assess the safety and biologic activity of daily oral administration of 4 escalating doses of sapropterin dihydrochloride over 16 weeks in subjects with sickle cell disease. During an optional extension phase, the study will assess the safety, tolerability, and efficacy of extended treatment with sapropterin dihydrochloride, for a total of up to 2 years; The extension phase of this study was terminated. | This Phase 2a, multicenter, open-label, dose-escalation study was designed to assess the safety and biological activity of once-daily (or twice-daily \[BID\], only for the highest dose level) oral administration of 4 escalating doses of sapropterin dihydrochloride to subjects with Sickle Cell Disease (SCD); 32 subjects were enrolled in the dose-escalation phase of this study. Subjects received oral, once daily (for 2.5, 5, and 10 mg/kg/day) or BID (for 20 mg/kg/day) doses of sapropterin dihydrochloride during a 16-week, dose-escalation period, with dose levels increasing within subjects every 4 weeks, as follows: 2.5, 5, 10, and 20 mg/kg/day. At the highest dose level (20 mg/kg/day), the total dose of sapropterin dihydrochloride was divided, half of the tablets taken in the morning within 1 hour after a meal, and half approximately 12 hours later (or BID) within 1 hour after a meal. The extension phase of this study was terminated. | Sickle Cell Disease | Sickle Cell Disease SCD 6R-BH4 BH4 sapropterin dihydrochloride endothelial dysfunction Nitric Oxide NO | null | 1 | arm 1: 2.5, 5, 10, 20 mg/kg/day of sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks, with an optional extension phase at the highest tolerated dose for up to a total of 2 years. | [
0
] | 1 | [
0
] | intervention 1: Subjects will receive oral, once-daily (for 2.5, 5, 10mg/kg/day doses) or twice-daily (for the 20 mg/kg/day dose) sapropterin dihydrochloride during a 16-week dose escalation phase, with dose levels increasing within subjects every 4 weeks as follows: 2.5, 5, 10, and 20 mg/kg/day. Dosing was with 100 mg tablets and rounded to the nearest whole tablet. Each dose was taken within 1 hour after the morning meal. Subjects may continue in an optional extension phase at the highest tolerated dose for up to a total of 2 years. | intervention 1: Sapropterin Dihydrochloride | 12 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Augusta | Georgia | United States | -81.97484 | 33.47097
Savannah | Georgia | United States | -81.09983 | 32.08354
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Detroit | Michigan | United States | -83.04575 | 42.33143
Flint | Michigan | United States | -83.68746 | 43.01253
Hackensack | New Jersey | United States | -74.04347 | 40.88593
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Galveston | Texas | United States | -94.7977 | 29.30135
Norfolk | Virginia | United States | -76.28522 | 36.84681
Richmond | Virginia | United States | -77.46026 | 37.55376 | 107 | 0 | 0 | 0 | NCT00445978 | 1COMPLETED | 2009-06-01 | 2007-05-01 | BioMarin Pharmaceutical | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 250 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension. | null | Hypertension | children pediatrics high blood pressure hypertension valsartan enalapril | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
1,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. intervention 2: Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food. intervention 3: Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food. intervention 4: placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food. | intervention 1: Valsartan intervention 2: Enalapril intervention 3: placebo matched to enalapril intervention 4: placebo matched to valsartan | 9 | East Hanover | New Jersey | United States | -74.36487 | 40.8201
Belgium | N/A | Belgium | N/A | N/A
France | N/A | France | -0.84802 | 45.60366
Germany | N/A | Germany | N/A | N/A
Hungary | N/A | Hungary | N/A | N/A
India | N/A | India | 75.36261 | 23.01533
Italy | N/A | Italy | N/A | N/A
Poland | N/A | Poland | N/A | N/A
Turkey | N/A | Turkey (Türkiye) | N/A | N/A | 250 | 0 | 0 | 0 | NCT00446511 | 1COMPLETED | 2009-06-01 | 2007-06-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 505 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is determine whether the combination of naltrexone SR and bupropion SR is safe and effective in treating obesity in subjects with type 2 diabetes. | Optimal care of patients with diabetes mellitus includes vigorous and persistent efforts to achieve physiologic control of blood glucose as well as other often associated conditions including hypertension, dyslipidemia and excess weight. Pharmacologic interventions for the treatment of obesity in type 2 diabetes have shown significant reductions in HbA1c. Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with type 2 diabetes mellitus. | Obesity Overweight Diabetes Mellitus, Type 2 | Obesity Overweight Diabetes Mellitus, Type 2 | null | 2 | arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/ day with ancillary therapy arm 2: Placebo with ancillary therapy | [
0,
2
] | 3 | [
0,
0,
5
] | intervention 1: None intervention 2: None intervention 3: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling | intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/ day intervention 2: Placebo intervention 3: Ancillary therapy | 53 | Fairhope | Alabama | United States | -87.90333 | 30.52297
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Beverly Hills | California | United States | -118.40036 | 34.07362
Carmichael | California | United States | -121.32828 | 38.61713
Fresno | California | United States | -119.77237 | 36.74773
Orange | California | United States | -117.85311 | 33.78779
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Santa Ana | California | United States | -117.86783 | 33.74557
Waterbury | Connecticut | United States | -73.0515 | 41.55815
Fort Myers | Florida | United States | -81.84059 | 26.62168
Miami | Florida | United States | -80.19366 | 25.77427
Palm Harbor | Florida | United States | -82.76371 | 28.07807
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Augusta | Georgia | United States | -81.97484 | 33.47097
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Evansville | Indiana | United States | -87.55585 | 37.97476
Valparaiso | Indiana | United States | -87.06114 | 41.47309
Lexington | Kentucky | United States | -84.47772 | 37.98869
Louisville | Kentucky | United States | -85.75941 | 38.25424
Madisonville | Kentucky | United States | -87.49889 | 37.3281
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Slidell | Louisiana | United States | -89.78117 | 30.27519
Baltimore | Maryland | United States | -76.61219 | 39.29038
Springfield | Massachusetts | United States | -72.58981 | 42.10148
Brooklyn Center | Minnesota | United States | -93.33273 | 45.07608
Kansas City | Missouri | United States | -94.57857 | 39.09973
St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727
Reno | Nevada | United States | -119.8138 | 39.52963
Dover | New Hampshire | United States | -70.87367 | 43.19786
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Flushing | New York | United States | -73.81736 | 40.76538
Manlius | New York | United States | -75.97686 | 43.00201
Rochester | New York | United States | -77.61556 | 43.15478
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Cleveland | Ohio | United States | -81.69541 | 41.4995
Columbus | Ohio | United States | -82.99879 | 39.96118
Kettering | Ohio | United States | -84.16883 | 39.6895
Mentor | Ohio | United States | -81.33955 | 41.66616
Greer | South Carolina | United States | -82.22706 | 34.93873
Mt. Pleasant | South Carolina | United States | -79.86259 | 32.79407
Chattanooga | Tennessee | United States | -85.30968 | 35.04563
Nashville | Tennessee | United States | -86.78444 | 36.16589
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Midland | Texas | United States | -102.07791 | 31.99735
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Seattle | Washington | United States | -122.33207 | 47.60621
Spokane | Washington | United States | -117.42908 | 47.65966 | 502 | 0 | 0 | 0 | NCT00474630 | 1COMPLETED | 2009-06-01 | 2007-05-01 | Orexigen Therapeutics, Inc | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Hypotheses:
1. Primary null hypothesis: The rate of clinical response, assessed as patient-reported global symptom rating and "adequate relief of IBS symptoms," does not differ between non-depressed IBS patients treated with the SSRI citalopram and patients treated with placebo.
2. Secondary null hypotheses:
1. Changes in disease-related quality of life, assessed with the IBS-QOL instrument, do not differ between patients treated with the SSRI citalopram and patients treated with placebo.
2. Changes in rectosigmoid visceral sensitivity, assessed by barostat balloon distention, do not differ between patients treated with the SSRI citalopram and patients treated with placebo. | Irritable bowel syndrome (IBS) affects an estimated 15 million Americans at a cost of $1.7 billion per year. Visceral hypersensitivity is present in many patients with IBS, but its contribution to clinical symptoms is unclear. Tricyclic antidepressants may be beneficial in IBS, but their side effects can be unacceptable. Because they are better tolerated, selective serotonin reuptake inhibitors (SSRIs) are often used to treat IBS, but their efficacy in IBS has not been examined in controlled studies. We propose a randomized, placebo-controlled trial of SSRI treatment in IBS. Non-depressed patients will be studied in order to assess SSRI effects on IBS independent of depression. Our specific aims are: 1) To determine whether the SSRI citalopram is superior to placebo in improving clinical symptoms, disease-related quality of life, and tolerance to rectal balloon distension; 2) To assess whether symptomatic improvement is correlated with improvement in quality of life and/or visceral sensitivity. Subjects will fulfill Rome II IBS criteria, will have normal screening studies, and will not be depressed or on antidepressants. Global and specific symptoms, and satisfaction will be rated daily during a 1-week baseline. Subjects will then be randomized in concealed, double-blind fashion to citalopram or placebo, will complete the validated IBS-QOL instrument, and will undergo rectal compliance and sensory testing with a barostat. Subjects will be treated and will rate symptoms and satisfaction weekly for a total of 8 weeks, and also daily during the final week for comparison with the baseline. At study end, subjects will again complete the IBS-QOL and undergo a barostat study. For the primary outcome, we estimate that to detect a standardized effect size of 0.9 in global symptom rating with 2-sided α=0.05 and β=0.1, 54 subjects are needed. We plan to enroll 60 subjects, which will allow detection of an odds ratio for response (adequate relief) of 4.5 with 2-sided α=0.05 and β=0.2. If the odds ratio for this dichotomous outcome is smaller, this study will provide pilot data for a larger trial. Clinical symptoms are expected to fluctuate. Even if citalopram is not superior to placebo, prospectively collected data will illuminate the relationship between symptoms and visceral sensitivity, and the placebo effect. | Irritable Bowel Syndrome | Irritable bowel syndrome Antidepressant IBS Serotonin-reuptake inhibitor SSRI Visceral sensitivity Barostat Quality of life Depression | null | 2 | arm 1: One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks arm 2: Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 20mg/day for 4 weeks, then 40 mg/day for 4 weeks intervention 2: Identical to citalopram 20mg capsules; 1 capsule/day for 4 weeks, then 2 capsules/day for 4 weeks | intervention 1: Citalopram intervention 2: Placebo | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 54 | 0 | 0 | 0 | NCT00477165 | 1COMPLETED | 2009-06-01 | 2001-04-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 103 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 0ALL | true | The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) cognitive function. | Some studies suggest that statin medications, which are a group of cholesterol-lowering medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans. The purpose of this study is to see how simvastatin affects a substance in the spinal fluid around the brain called beta-amyloid-42 which is thought to contribute to Alzheimer's disease. This study also evaluates whether simvastatin improves regional brain blood flow (on magnetic resonance imaging \[MRI\]), reduces inflammation, and improves cognitive function.
The ESPRIT study was a 9-month randomized, controlled clinical trial that randomized 100 middle-aged adults with a parental history of Alzheimer's disease. Participants were randomized to simvastatin 40 mg for one month then 80 mg daily or matching placebo tablets. Fifty of the ESPRIT subjects participated in the MRI sub-study.
Participants had the following data collected: fasting blood tests (baseline and months 3 and 9), medical history and medication questionnaires (each visit), study medication side effect review (all visits), lumbar puncture procedure (baseline and month 9), memory testing (baseline and months 3 and 9), and MRI (baseline and month 9 in 50 sub-study participants). | Alzheimer Disease | amyloid protein apolipoprotein cerebrospinal fluid cerebrovascular circulation inflammation magnetic resonance imaging prevention & control | null | 2 | arm 1: simvastatin 40 mg nightly for 1 month then 80 mg nightly for 8 months arm 2: Matching placebo tablet nightly for 9 months | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 40 mg tablet each night for one month, then 80 mg for 8 months intervention 2: Matching tablet each night for 9 months | intervention 1: Simvastatin intervention 2: Placebo | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 100 | 0 | 0 | 0 | NCT00486044 | 1COMPLETED | 2009-06-01 | 2005-02-01 | University of Wisconsin, Madison | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,166 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the long term; characterize adverse events and tolerability, sleep quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall impression of change; and characterize patient-related health outcomes. | All patients who complete the Phase 3 pivotal trials in osteoarthritis (R331333-PAI-3008; KF5503/11) and low back pain (R331333-PAI-3011; KF5503/23) and the Phase 3 safety trial in the non-European sites (R331333-PAI-3007; KF5503/24) will be allowed to continue participation in the program by entering this trial. The trial will consist of three periods (screening, open-label treatment period, and follow-up). In the open-label treatment/maintenance period (1 year), those patients in the safety trial R331333-PAI-3007 (KF5503/24) taking open-label Tapentadol (CG5503) extended release (ER) will continue the dosage they were taking without undergoing titration. All other patients will be titrated to the minimum therapeutic dosage of Tapentadol (CG5503) extended release (ER) over 1 week. The lowest therapeutic dose allowed in the study is 100 mg twice daily, and the maximum upper dosage of Tapentadol (CG5503) extended release (ER) base is 250 mg twice daily. Downward titration (not below the minimum therapeutic dose of 100 mg twice daily) is permitted at any time using the same decrements without any time restriction. Dosages will be assessed at the scheduled (and unscheduled, if any) visits and adjustment under investigator supervision will be made as necessary. Dosage adjustments should be kept to a minimum. Intake of paracetamol/acetaminophen two 500 mg tablets daily is permitted during the titration week, and during the remainder of the open-label treatment/maintenance period up to a maximum of 7 consecutive days but no more than 14 out of 30 days. Following Week 4, all visits will be scheduled at 4-week intervals, through Week 52. The end-of-treatment visit at Week 52 will include both safety and efficacy assessments. Patients will return to the site for a follow-up visit approximately 4 days after their last dose of Tapentadol (CG5503) extended release (ER) for final safety evaluations and completion of the opioid withdrawal assessments (clinical opioid withdrawal scale, or COWS, and subjective opioid withdrawal scale, or SOWS). Patients experiencing withdrawal symptoms prior to the follow-up visit may telephone and request to be seen sooner. Additionally, the research staff at the site will telephone subjects approximately 10 to 14 days after the last dose of Tapentadol (CG5503) extended release (ER) to inquire if any adverse events have occurred since the previous visit. Tapentadol (CG5503) extended release (ER): 50, 100, 150, 200, and 250 mg orally, taken twice daily (morning and evening) for a maximum duration of 1 year. | Pain Osteoarthritis Low Back Pain | CG5503 Tapentadol chronic non-malignant pain osteoarthritis lower back pain analgesic opioid | null | 1 | arm 1: Tapentadol (CG5503) Extended Release (ER) 100 150 200 250 mg oral tablet twice daily for 52 weeks | [
0
] | 1 | [
0
] | intervention 1: 100, 150, 200, 250 mg oral tablet twice daily for 52 weeks | intervention 1: Tapentadol (CG5503) Extended Release (ER) | 148 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Hoover | Alabama | United States | -86.81138 | 33.40539
Mobile | Alabama | United States | -88.04305 | 30.69436
Mesa | Arizona | United States | -111.82264 | 33.42227
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -111.90931 | 33.41477
Tucson | Arizona | United States | -110.92648 | 32.22174
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | United States | -117.9145 | 33.83529
Carmichael | California | United States | -121.32828 | 38.61713
Encinitas | California | United States | -117.29198 | 33.03699
Fresno | California | United States | -119.77237 | 36.74773
Huntington Park | California | United States | -118.22507 | 33.98168
Laguna Hills | California | United States | -117.71283 | 33.61252
Los Gatos | California | United States | -121.97468 | 37.22661
Pico Rivera | California | United States | -118.09673 | 33.98307
Pismo Beach | California | United States | -120.64128 | 35.14275
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Upland | California | United States | -117.64839 | 34.09751
Westlake Village | California | United States | -118.80565 | 34.14584
Stamford | Connecticut | United States | -73.53873 | 41.05343
Trumbull | Connecticut | United States | -73.20067 | 41.24287
Chiefland | Florida | United States | -82.85984 | 29.47496
Clearwater | Florida | United States | -82.8001 | 27.96585
Fort Myers | Florida | United States | -81.84059 | 26.62168
Hallandale | Florida | United States | -80.14838 | 25.9812
Hollywood | Florida | United States | -80.14949 | 26.0112
Jacksonville | Florida | United States | -81.65565 | 30.33218
Kissimmee | Florida | United States | -81.41667 | 28.30468
Miami | Florida | United States | -80.19366 | 25.77427
New Port Richey | Florida | United States | -82.71927 | 28.24418
Oldsmar | Florida | United States | -82.6651 | 28.03418
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Plantation | Florida | United States | -80.23184 | 26.13421
Port Orange | Florida | United States | -80.99561 | 29.13832
Sarasota | Florida | United States | -82.53065 | 27.33643
Tamarac | Florida | United States | -80.24977 | 26.21286
Tampa | Florida | United States | -82.45843 | 27.94752
Athens | Georgia | United States | -83.37794 | 33.96095
Augusta | Georgia | United States | -81.97484 | 33.47097
Decatur | Georgia | United States | -84.29631 | 33.77483
Marietta | Georgia | United States | -84.54993 | 33.9526
Perry | Georgia | United States | -83.73157 | 32.45821
Suwanee | Georgia | United States | -84.0713 | 34.05149
Woodstock | Georgia | United States | -84.51938 | 34.10149
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Boise | Idaho | United States | -116.20345 | 43.6135
Meridian | Idaho | United States | -116.39151 | 43.61211
Chicago | Illinois | United States | -87.65005 | 41.85003
Avon | Indiana | United States | -86.39972 | 39.76282
Evansville | Indiana | United States | -87.55585 | 37.97476
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Valparaiso | Indiana | United States | -87.06114 | 41.47309
West Des Moines | Iowa | United States | -93.71133 | 41.57721
Overland Park | Kansas | United States | -94.67079 | 38.98223
Prairie Village | Kansas | United States | -94.63357 | 38.99167
Topeka | Kansas | United States | -95.67804 | 39.04833
Madisonville | Kentucky | United States | -87.49889 | 37.3281
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Lake Charles | Louisiana | United States | -93.2044 | 30.21309
Mandeville | Louisiana | United States | -90.06563 | 30.35825
Metairie | Louisiana | United States | -90.15285 | 29.98409
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Columbia | Maryland | United States | -76.83942 | 39.24038
Owings Mills | Maryland | United States | -76.78025 | 39.41955
Rockville | Maryland | United States | -77.15276 | 39.084
Boston | Massachusetts | United States | -71.05977 | 42.35843
Brighton | Massachusetts | United States | -71.15644 | 42.3501
Fall River | Massachusetts | United States | -71.15505 | 41.70149
North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899
Wellesley Hills | Massachusetts | United States | -71.27867 | 42.30843
West Yarmouth | Massachusetts | United States | -70.24113 | 41.65011
East Lansing | Michigan | United States | -84.48387 | 42.73698
Grand Blanc | Michigan | United States | -83.62995 | 42.92753
Kalamazoo | Michigan | United States | -85.58723 | 42.29171
Troy | Michigan | United States | -83.14993 | 42.60559
St Louis | Missouri | United States | -90.19789 | 38.62727
Omaha | Nebraska | United States | -95.94043 | 41.25626
Cherry Hill | New Jersey | United States | -75.03073 | 39.93484
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Mamaroneck | New York | United States | -73.73263 | 40.94871
New York | New York | United States | -74.00597 | 40.71427
Williamsville | New York | United States | -78.73781 | 42.96395
Greensboro | North Carolina | United States | -79.79198 | 36.07264
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Kettering | Ohio | United States | -84.16883 | 39.6895
Toledo | Ohio | United States | -83.55521 | 41.66394
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Medford | Oregon | United States | -122.87559 | 42.32652
Allentown | Pennsylvania | United States | -75.49018 | 40.60843
Chester | Pennsylvania | United States | -75.35785 | 39.84753
Duncansville | Pennsylvania | United States | -78.4339 | 40.42341
Morrisville | Pennsylvania | United States | -74.78794 | 40.2115
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Greenville | South Carolina | United States | -82.39401 | 34.85262
Prosperity | South Carolina | United States | -81.53316 | 34.20931
Sioux Falls | South Dakota | United States | -96.70033 | 43.54997
Clarksville | Tennessee | United States | -87.35945 | 36.52977
Nashville | Tennessee | United States | -86.78444 | 36.16589
Amarillo | Texas | United States | -101.8313 | 35.222
Austin | Texas | United States | -97.74306 | 30.26715
Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | United States | -95.36327 | 29.76328
Hurst | Texas | United States | -97.17057 | 32.82346
Lubbock | Texas | United States | -101.85517 | 33.57786
Odessa | Texas | United States | -102.36764 | 31.84568
San Antonio | Texas | United States | -98.49363 | 29.42412
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Danville | Virginia | United States | -79.39502 | 36.58597
Roanoke | Virginia | United States | -79.94143 | 37.27097
Virginia Beach | Virginia | United States | -75.97799 | 36.85293
Bellevue | Washington | United States | -122.20068 | 47.61038
Tacoma | Washington | United States | -122.44429 | 47.25288
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Adelaide | N/A | Australia | 138.59863 | -34.92866
Melbourne | N/A | Australia | 144.96332 | -37.814
Newcastle | N/A | Australia | 151.7801 | -32.92953
Woodville North | N/A | Australia | 138.54309 | -34.872
Chilliwack | British Columbia | Canada | -121.95257 | 49.16638
Kelowna | British Columbia | Canada | -119.48568 | 49.88307
Penticton | British Columbia | Canada | -119.58584 | 49.48062
Vancouver | British Columbia | Canada | -123.11934 | 49.24966
St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494
Ajax | Ontario | Canada | -79.03288 | 43.85012
Brampton | Ontario | Canada | -79.76633 | 43.68341
Greater Sudbury | Ontario | Canada | -80.99001 | 46.49
Kitchener | Ontario | Canada | -80.5112 | 43.42537
London | Ontario | Canada | -81.23304 | 42.98339
Markham | Ontario | Canada | -79.2663 | 43.86682
Mississauga | Ontario | Canada | -79.6583 | 43.5789
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Sarnia | Ontario | Canada | -82.40407 | 42.97866
Toronto | Ontario | Canada | -79.39864 | 43.70643
Vancouver | Ontario | Canada | N/A | N/A
Charlottetown | Prince Edward Island | Canada | -63.1256 | 46.23459
Montreal | Quebec | Canada | -73.58781 | 45.50884
Pointe-Claire | Quebec | Canada | -73.81669 | 45.44868
Saint Romuald | Quebec | Canada | -71.23921 | 46.75818
Sherbrooke | Quebec | Canada | -71.89908 | 45.40008
Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238
Halifax | N/A | Canada | -63.57688 | 44.64269
Christchurch | N/A | New Zealand | 172.63333 | -43.53333
Tauranga | N/A | New Zealand | 176.16667 | -37.68611
Wellington | N/A | New Zealand | 174.77557 | -41.28664 | 1,154 | 0 | 0 | 0 | NCT00487435 | 1COMPLETED | 2009-06-01 | 2007-06-01 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 25 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels. | Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke. Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH, this critically important issue needs further studies.
One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80 mg per mouth daily), while the control group will receive a sugar tablet. The treatment will be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures, these are included with the application for your review) at day 21 post aSAH will be reviewed at time of discharge as well at 6 months of follow up. | Aneurysmal Subarachnoid Hemorrhage Cerebral Vasospasm | SAH Vasospasm | null | 3 | arm 1: Placebo tablet arm 2: Simvastatin 40 mg arm 3: Simvastatin 80 mg | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Comparing two doses of Simvastatin to placebo intervention 2: Placebo tablet intervention 3: Comparing two doses of Simvastatin to placebo | intervention 1: Simvastatin 40 mg intervention 2: Placebo intervention 3: Simvastatin 80 mg | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | 0 | 0 | 0 | NCT00487461 | 6TERMINATED | 2009-06-01 | 2007-05-01 | University of Illinois at Chicago | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 118 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\].
Secondary objectives were:
* to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;
* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β. | The study period per participant was approximatively 44 weeks broken down as follows:
* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.
'\*' participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395. | Multiple Sclerosis | MS interferon-beta adjunctive therapy relapses | null | 3 | arm 1: Teriflunomide 7 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks arm 2: Teriflunomide 14 mg once daily concomitantly with Interferon-β (IFN-β) for 24 weeks arm 3: Placebo (for Teriflunomide) once daily concomitantly with Interferon-β (IFN-β) for 24 weeks | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Film-coated tablet
Oral administration intervention 2: Film-coated tablet
Oral administration intervention 3: Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection | intervention 1: Teriflunomide intervention 2: Placebo (for Teriflunomide) intervention 3: Interferon-β | 5 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Laval | N/A | Canada | -73.692 | 45.56995
Berlin | N/A | Germany | 13.41053 | 52.52437
Milan | N/A | Italy | 9.18951 | 45.46427
Barcelona | N/A | Spain | 2.15899 | 41.38879 | 116 | 0 | 0 | 0 | NCT00489489 | 1COMPLETED | 2009-06-01 | 2007-05-01 | Sanofi | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,461 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status. | null | Alzheimer's Disease | cognition Alzheimer's disease Rosiglitazone extended-release (XR) safety adjunctive therapy BRL-049653 tolerability open-label extension | null | 1 | arm 1: Investigational drug | [
0
] | 1 | [
0
] | intervention 1: Experimental drug | intervention 1: Rosiglitazone XR | 272 | Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fresno | California | United States | -119.77237 | 36.74773
Rancho Mirage | California | United States | -116.41279 | 33.73974
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Sherman Oaks | California | United States | -118.44925 | 34.15112
New Haven | Connecticut | United States | -72.92816 | 41.30815
Norwalk | Connecticut | United States | -73.4079 | 41.1176
Deerfield Beach | Florida | United States | -80.09977 | 26.31841
Delray Beach | Florida | United States | -80.07282 | 26.46146
Hialeah | Florida | United States | -80.27811 | 25.8576
Ocala | Florida | United States | -82.14009 | 29.1872
St. Petersburg | Florida | United States | -82.67927 | 27.77086
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Rockville | Maryland | United States | -77.15276 | 39.084
Springfield | Massachusetts | United States | -72.58981 | 42.10148
West Yarmouth | Massachusetts | United States | -70.24113 | 41.65011
Saint Paul | Minnesota | United States | -93.09327 | 44.94441
Morristown | New Jersey | United States | -74.48154 | 40.79677
Stratford | New Jersey | United States | -75.01545 | 39.82678
Toms River | New Jersey | United States | -74.19792 | 39.95373
Albany | New York | United States | -73.75623 | 42.65258
Brooklyn | New York | United States | -73.94958 | 40.6501
New York | New York | United States | -74.00597 | 40.71427
Syracuse | New York | United States | -76.14742 | 43.04812
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Columbus | Ohio | United States | -82.99879 | 39.96118
Toledo | Ohio | United States | -83.55521 | 41.66394
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Providence | Rhode Island | United States | -71.41283 | 41.82399
Austin | Texas | United States | -97.74306 | 30.26715
South Ogden | Utah | United States | -111.97133 | 41.19189
Bennington | Vermont | United States | -73.19677 | 42.87813
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Ciudad Autónoma de Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Ciudad de Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Córdoba | Córdoba Province | Argentina | -64.18853 | -31.40648
Córdoba | Córdoba Province | Argentina | -64.18853 | -31.40648
Córdoba | Córdoba Province | Argentina | -64.18853 | -31.40648
Godoy Cruz | Mendoza Province | Argentina | -68.84428 | -32.92533
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Mendoza | N/A | Argentina | -68.84582 | -32.88946
Hornsby | New South Wales | Australia | 151.09931 | -33.70244
Randwick | New South Wales | Australia | 151.24895 | -33.91439
Auchenflower | Queensland | Australia | 152.99213 | -27.47443
Chermside | Queensland | Australia | 153.03062 | -27.38472
Kippa-Ring | Queensland | Australia | 153.0835 | -27.22586
Woodville | South Australia | Australia | 138.54291 | -34.877
Cheltenham | Victoria | Australia | 145.04806 | -37.96944
Heidelberg Heights | Victoria | Australia | 145.05695 | -37.74313
Kew | Victoria | Australia | 145.03086 | -37.80639
Nedlands | Western Australia | Australia | 115.8073 | -31.98184
Hall in Tirol | N/A | Austria | 11.51667 | 47.28333
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Kortrijk | N/A | Belgium | 3.26487 | 50.82803
Leuven | N/A | Belgium | 4.70093 | 50.87959
Woluwe-Saint-Lambert | N/A | Belgium | 4.42912 | 50.84389
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Varna | N/A | Bulgaria | 27.91667 | 43.21667
Saint John | New Brunswick | Canada | -66.05616 | 45.27076
Kentville | Nova Scotia | Canada | -64.49605 | 45.0771
Kingston | Ontario | Canada | -76.48098 | 44.22976
Kingston | Ontario | Canada | -76.48098 | 44.22976
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Peterborough | Ontario | Canada | -78.31623 | 44.30012
Toronto | Ontario | Canada | -79.39864 | 43.70643
Toronto | Ontario | Canada | -79.39864 | 43.70643
Toronto | Ontario | Canada | -79.39864 | 43.70643
Whitby | Ontario | Canada | -78.93287 | 43.88342
Charlottetown | Prince Edward Island | Canada | -63.1256 | 46.23459
Greenfield Park | Quebec | Canada | -73.46223 | 45.48649
Montreal | Quebec | Canada | -73.58781 | 45.50884
Montreal | Quebec | Canada | -73.58781 | 45.50884
Sherbrooke | Quebec | Canada | -71.89908 | 45.40008
Sherbrooke | Quebec | Canada | -71.89908 | 45.40008
Regina | Saskatchewan | Canada | -104.6178 | 50.45008
Québec | N/A | Canada | -71.21454 | 46.81228
Viña del Mar | Región de Valparaíso | Chile | -71.55183 | -33.02457
Providencia / Santiago | Región Metro de Santiago | Chile | N/A | N/A
Santiago | Región Metro de Santiago | Chile | -70.64827 | -33.45694
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Ostrava | N/A | Czechia | 18.28204 | 49.83465
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Trutnov | N/A | Czechia | 15.9127 | 50.56101
Helsinki | N/A | Finland | 24.93545 | 60.16952
Kuopio | N/A | Finland | 27.67703 | 62.89238
Bourg-en-Bresse | N/A | France | 5.2258 | 46.20574
Caen | N/A | France | -0.35912 | 49.18585
Dijon | N/A | France | 5.01667 | 47.31667
Ivry | N/A | France | 2.39278 | 47.14313
La Seyne-sur-Mer | N/A | France | 5.87816 | 43.10322
Lille | N/A | France | 3.05858 | 50.63297
Limoges | N/A | France | 1.24759 | 45.83362
Luynes | N/A | France | 0.5547 | 47.38441
Lyon | N/A | France | 4.84671 | 45.74846
Marseille | N/A | France | 5.38107 | 43.29695
Marseille | N/A | France | 5.38107 | 43.29695
Metz | N/A | France | 6.17269 | 49.11911
Nantes | N/A | France | -1.55336 | 47.21725
Nantes | N/A | France | -1.55336 | 47.21725
Nantes | N/A | France | -1.55336 | 47.21725
Nantes | N/A | France | -1.55336 | 47.21725
Nice | N/A | France | 7.26608 | 43.70313
Paris | N/A | France | 2.3488 | 48.85341
Pau | N/A | France | -0.35583 | 43.31117
Rodez | N/A | France | 2.57338 | 44.35258
Saint-Etienne | N/A | France | 4.39 | 45.43389
Saint-Ouen-la-Rouërie | N/A | France | -1.44093 | 48.46234
Sautron | N/A | France | -1.67222 | 47.26345
Tinténiac | N/A | France | -1.83545 | 48.32908
Toulon | N/A | France | 5.92836 | 43.12442
Toulouse | N/A | France | 1.44367 | 43.60426
Tours | N/A | France | 0.70398 | 47.39484
Vichy | N/A | France | 3.42577 | 46.12709
Aalen | Baden-Wurttemberg | Germany | 10.0933 | 48.83777
Ellwangen | Baden-Wurttemberg | Germany | 10.13173 | 48.96164
Ludwigsburg | Baden-Wurttemberg | Germany | 9.19161 | 48.89731
Ostfildern | Baden-Wurttemberg | Germany | 9.24954 | 48.72704
Stuttgart | Baden-Wurttemberg | Germany | 9.17702 | 48.78232
Tübingen | Baden-Wurttemberg | Germany | 9.05222 | 48.52266
Ulm | Baden-Wurttemberg | Germany | 9.99155 | 48.39841
Alzenau in Unterfranken | Bavaria | Germany | 9.06455 | 50.0888
Munich | Bavaria | Germany | 11.57549 | 48.13743
Munich | Bavaria | Germany | 11.57549 | 48.13743
Munich | Bavaria | Germany | 11.57549 | 48.13743
Munich | Bavaria | Germany | 11.57549 | 48.13743
Nuremberg | Bavaria | Germany | 11.07752 | 49.45421
Regensburg | Bavaria | Germany | 12.10161 | 49.01513
Unterhaching | Bavaria | Germany | 11.61564 | 48.06598
Bad Saarow | Brandenburg | Germany | 14.06667 | 52.28333
Bad Homburg | Hesse | Germany | 8.61816 | 50.22683
Erbach im Odenwald | Hesse | Germany | 8.99402 | 49.66148
Achim | Lower Saxony | Germany | 9.0263 | 53.01416
Bockhorn | Lower Saxony | Germany | 8.01667 | 53.4
Ganderkesee | Lower Saxony | Germany | 8.53333 | 53.03333
Göttingen | Lower Saxony | Germany | 9.93228 | 51.53443
Hanover | Lower Saxony | Germany | 9.73322 | 52.37052
Lüneburg | Lower Saxony | Germany | 10.41409 | 53.2509
Westerstede | Lower Saxony | Germany | 7.92737 | 53.25682
Schwerin | Mecklenburg-Vorpommern | Germany | 11.41316 | 53.62937
Bad Honnef | North Rhine-Westphalia | Germany | 7.2278 | 50.64336
Baesweiler | North Rhine-Westphalia | Germany | 6.18874 | 50.90964
Bergisch Gladbach | North Rhine-Westphalia | Germany | 7.13298 | 50.9856
Bochum | North Rhine-Westphalia | Germany | 7.21648 | 51.48165
Bochum | North Rhine-Westphalia | Germany | 7.21648 | 51.48165
Bochum | North Rhine-Westphalia | Germany | 7.21648 | 51.48165
Cologne | North Rhine-Westphalia | Germany | 6.95 | 50.93333
Duisburg | North Rhine-Westphalia | Germany | 6.76516 | 51.43247
Düren | North Rhine-Westphalia | Germany | 6.49299 | 50.80434
Essen | North Rhine-Westphalia | Germany | 7.01228 | 51.45657
Hattingen | North Rhine-Westphalia | Germany | 7.18557 | 51.39894
Jülich | North Rhine-Westphalia | Germany | 6.36267 | 50.92149
Krefeld | North Rhine-Westphalia | Germany | 6.55381 | 51.33645
Siegen | North Rhine-Westphalia | Germany | 8.02431 | 50.87481
Chemnitz | Saxony | Germany | 12.92922 | 50.8357
Dresden | Saxony | Germany | 13.73832 | 51.05089
Dresden | Saxony | Germany | 13.73832 | 51.05089
Leipzig | Saxony | Germany | 12.37129 | 51.33962
Leipzig | Saxony | Germany | 12.37129 | 51.33962
Gera | Thuringia | Germany | 12.08187 | 50.88029
Jena | Thuringia | Germany | 11.5899 | 50.92878
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hamburg | N/A | Germany | 9.99302 | 53.55073
Athens | N/A | Greece | 23.72784 | 37.98376
Athens | N/A | Greece | 23.72784 | 37.98376
Melíssia | N/A | Greece | 23.83333 | 38.05
Thessaloniki | N/A | Greece | 22.93086 | 40.64361
Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
Shatin | N/A | Hong Kong | 114.18333 | 22.38333
Győr | N/A | Hungary | 17.63512 | 47.68333
Szeged | N/A | Hungary | 20.14824 | 46.253
Hyderabad | N/A | India | 78.45636 | 17.38405
Nagpur | N/A | India | 79.08491 | 21.14631
New Delhi | N/A | India | 77.2148 | 28.62137
Pune | N/A | India | 73.85535 | 18.51957
Varanasi | N/A | India | 83.01041 | 25.31668
Chieti Scalo | Abruzzo | Italy | N/A | N/A
Napoli | Campania | Italy | 14.5195 | 40.87618
San Felice A Cancello Caserta | Campania | Italy | N/A | N/A
Rome | Lazio | Italy | 12.51133 | 41.89193
Rome | Lazio | Italy | 12.51133 | 41.89193
Rome | Lazio | Italy | 12.51133 | 41.89193
Brescia | Lombardy | Italy | 10.21472 | 45.53558
Milan | Lombardy | Italy | 9.18951 | 45.46427
Milan | Lombardy | Italy | 9.18951 | 45.46427
Pavia | Lombardy | Italy | 9.15917 | 45.19205
Rho | Lombardy | Italy | 9.0402 | 45.53245
Torrette (AN) | The Marches | Italy | N/A | N/A
Arezzo | Tuscany | Italy | 11.88068 | 43.46276
Florence | Tuscany | Italy | 11.24626 | 43.77925
Pisa | Tuscany | Italy | 10.4036 | 43.70853
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
Mexico | N/A | Mexico | -98.43784 | 18.88011
's-Hertogenbosch | N/A | Netherlands | 5.30417 | 51.69917
Alkmaar | N/A | Netherlands | 4.74861 | 52.63167
Blaricum | N/A | Netherlands | 5.24167 | 52.2725
Hengelo | N/A | Netherlands | 6.79306 | 52.26583
Hilversum | N/A | Netherlands | 5.17639 | 52.22333
The Hague | N/A | Netherlands | 4.29861 | 52.07667
Pasig | N/A | Philippines | 121.0614 | 14.58691
Bydgoszcz | N/A | Poland | 18.00762 | 53.1235
Bydgoszcz | N/A | Poland | 18.00762 | 53.1235
Katowice | N/A | Poland | 19.02754 | 50.25841
Mosina | N/A | Poland | 16.84709 | 52.24543
Poznan | N/A | Poland | 16.92993 | 52.40692
Sopot | N/A | Poland | 18.56003 | 54.4418
Warsaw | N/A | Poland | 21.01178 | 52.22977
Coimbra | N/A | Portugal | -8.41955 | 40.20564
Lisbon | N/A | Portugal | -9.1498 | 38.72509
Bratislava | N/A | Slovakia | 17.10674 | 48.14816
Bratislava | N/A | Slovakia | 17.10674 | 48.14816
Bratislava | N/A | Slovakia | 17.10674 | 48.14816
Košice | N/A | Slovakia | 21.25808 | 48.71395
Ljubljana | N/A | Slovenia | 14.50513 | 46.05108
Šempeter v Savinj. Dolini | N/A | Slovenia | 15.12194 | 46.25639
Loeventstein | N/A | South Africa | N/A | N/A
Oakdale | N/A | South Africa | 18.63653 | -33.88906
Richards Bay | N/A | South Africa | 32.03768 | -28.78301
Rosebank | N/A | South Africa | 18.47417 | -33.95556
Somerset West | N/A | South Africa | 18.82113 | -34.08401
Waverley, Bloemfontein | N/A | South Africa | N/A | N/A
Willows, X14, Pretoria | N/A | South Africa | N/A | N/A
Seongnam-si | N/A | South Korea | 127.13778 | 37.43861
Seoul | N/A | South Korea | 126.9784 | 37.566
Seoul | N/A | South Korea | 126.9784 | 37.566
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Burgos | N/A | Spain | -3.70184 | 42.34106
Castellon | N/A | Spain | -0.04935 | 39.98567
Elche (Alicante) | N/A | Spain | -0.70107 | 38.26218
Girona | N/A | Spain | 2.82493 | 41.98311
Madrid | N/A | Spain | -3.70256 | 40.4165
Murcia | N/A | Spain | -1.13004 | 37.98704
Palma de Mallorca | N/A | Spain | 2.65024 | 39.56939
Tarrasa, Barcelona | N/A | Spain | 2.15899 | 41.38879
Valencia | N/A | Spain | -0.37966 | 39.47391
Jönköping | N/A | Sweden | 14.15618 | 57.78145
Kalix | N/A | Sweden | 23.15645 | 65.85298
Mölndal | N/A | Sweden | 12.01378 | 57.6554
Sundsvall | N/A | Sweden | 17.3063 | 62.39129
Umeå | N/A | Sweden | 20.25972 | 63.82842
Blackpool | Lancashire | United Kingdom | -3.05 | 53.81667
Bradford | N/A | United Kingdom | -1.75206 | 53.79391
Liverpool | N/A | United Kingdom | -2.97794 | 53.41058
West of Scotland Science Park, Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 | 1,461 | 0 | 0 | 0 | NCT00490568 | 6TERMINATED | 2009-06-01 | 2007-08-08 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
5
] | 69 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable, moderate asthma and a history of cat dander-induced asthma symptoms. | A cat dander allergen challenge model was used to collect data for all of the Outcome Measures. The cat allergen levels in the model are similar to those found in homes with cats and are capable of inducing lower- and upper-airway responses that have been used to assess the efficacy of several asthma and allergy therapies.
Cat allergen exposure was performed in a room furnished with upholstered furniture, a blanket, and a cat litter box. The door was kept closed at all times, except when personnel or study patients were entering or leaving the room. The ventilation system was operating at all times except during cat allergen challenges. Two neutered adult cats were kept in the room at all times and were free to move about except during challenges, at which time they are placed in wire cages. Immediately before a challenge, the blanket was shaken vigorously to distribute cat allergen throughout the room. | Asthma | Xolair Allergic asthma Cat allergy | null | 2 | arm 1: Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. arm 2: Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection. intervention 2: Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab. | intervention 1: Omalizumab intervention 2: Placebo | 0 | null | 69 | 0 | 0 | 0 | NCT00495612 | 1COMPLETED | 2009-06-01 | 2007-09-01 | Genentech, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 47 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well sirolimus works in treating patients with advanced pancreatic cancer. | OBJECTIVES:
Primary
* To determine the proportion of patients with previously treated advanced pancreatic cancer surviving at 6 months after treatment with single agent rapamycin.
* To evaluate the relationship between activation of the PI3/Akt/mTOR/S6K signaling pathway in tumor tissues and rapamycin activity in this patient population.
* To characterize toxicity of rapamycin in this patient population.
Secondary
* To determine the response rate, median time to treatment failure, and median survival of patients with previously treated advanced pancreatic cancer who are treated with single agent rapamycin.
* To characterize the pharmacokinetics of rapamycin in this patient population.
* To explore pharmacogenomic variables that affect rapamycin pharmacokinetics and clinical activity in this patient population.
* To determine the pharmacodynamic effects of rapamycin on S6 kinase activation in PBMC, normal skin, and normal oral mucosa obtained from patients treated with the drug and its relationship with rapamycin pharmacokinetics and clinical effects.
* To explore biomarkers in tumor tissues that might be associated with rapamycin clinical effects.
OUTLINE: Patients receive oral sirolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood, normal skin, and tumor tissue collection at baseline and periodically during study for pharmacological, biological, and genotyping studies. Blood samples are analyzed by LC/MS/MS assay to assess rapamycin pharmacokinetics (PKs) during courses 1 and 2 and to determine baseline CYP3A4 activity. Samples are also analyzed by genotyping studies to assess CYP3A4 polymorphisms. Pharmacodynamic activity of rapamycin is assessed in peripheral blood mononuclear cells isolated from PK blood samples using a kinase assay to measure S6K activity. Tumor tissue is collected from pretreatment tumor samples obtained at the time of diagnosis or surgery or by biopsy from patients for whom pre-study tumor specimens are not available. Patients undergo skin biopsies at baseline and on day 1 of course 2 to obtain samples of normal skin. Patients also undergo oral mucosa smears at baseline and weekly during course 1. Tumor tissue, normal skin, and oral mucosa samples are assessed by IHC staining of S6K and p-S6K and by RT-PCR for cyclin D1 and p27. | Pancreatic Cancer | recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas | null | 1 | arm 1: Sirolimus 5mg. po QD continously (28 days=cycle) | [
0
] | 1 | [
0
] | intervention 1: Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days. | intervention 1: sirolimus | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 31 | 0 | 0 | 0 | NCT00499486 | 1COMPLETED | 2009-06-01 | 2005-01-01 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to learn more about the effectiveness and side effects of lithium treatment for subjects with low-grade neuroendocrine tumors. | Lithium 300mg by mouth, three times daily, escalating to a lithium level of 0.8-1.0; Continue until progressive disease/unacceptable toxicity;Evaluate q 8 weeks. | Neuroendocrine Tumors | low-grade neuroendocrine tumors lithium | null | 1 | arm 1: Lithium carbonate will be dosed on a flat scale of mg/day and not by weight or body surface area (BSA). Lithium carbonate will be provided as a 300mg tablet and will be taken daily without breaks in treatment. | [
0
] | 1 | [
0
] | intervention 1: Lithium 300mg PO TID escalating to a lithium level of 0.8-1.2. Lithium carbonate will be administered the first week at 300 mg flat dose three times each day. A serum lithium level will be checked after 4-5 days of treatment by drawing a blood sample prior to the morning dose of lithium. Evaluate every 8 weeks. | intervention 1: Lithium Carbonate | 1 | Madison | Wisconsin | United States | -89.40123 | 43.07305 | 15 | 0 | 0 | 0 | NCT00501540 | 1COMPLETED | 2009-06-01 | 2007-07-01 | University of Wisconsin, Madison | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a multi-centre, phase II study to assess the efficacy and safety of ZD6474 in patients with Child-Pugh class A, inoperable HCC. This study comprises 2 phases, the primary treatment phase and the secondary treatment phase. The primary treatment phase is a randomised, double-blind, parallel-group phase II study to assess the efficacy and safety of ZD6474 300 mg plus best support care (BSC), ZD6474 100 mg plus BSC, and placebo plus BSC. The secondary treatment phase is an open-label expanded access program of ZD6474. In the primary treatment phase, patients will be randomised in a 1:1:1 ratio to receive ZD6474 300 mg plus BSC, ZD6474 100 mg plus BSC, or placebo plus BSC, respectively. Randomisation will be stratified on the basis of Cancer of the Liver Italian Programme (CLIP) tumour staging (CLIP score 0-2 versus 3-4). The primary treatment will continue until objective disease progression, according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or until patients meet any other withdrawal or discontinuation criteria.The primary endpoint is tumour stabilisation rate, and the secondary endpoints are objective response rate, progression-free survival, and overall survival. The purpose of the secondary treatment phase is to expand the access of ZD6474 so that every patient who is enrolled into this study can have the chance to receive the active medicine.Once an individual patient has progressive disease in the primary treatment phase, the blind will be broken for this patient. If this patient is in the ZD6474 100 mg arm or placebo arm, the patient will be offered the secondary treatment with ZD6474 300 mg per day. If this patient is randomised to the ZD6474 300 mg arm, the study medication will be discontinued unless the patient wishes to remain the treatment, and the patient is to be followed up for survival. | null | Carcinoma, Hepatocellular | Hepatocellular carcinoma Advanced solid, malignant tumour | null | 3 | arm 1: Best Supportive Care + Placebo arm 2: Best Supportive Care + ZD6474 100 mg arm 3: Best Supportive Care + ZD6474 300 mg | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: ZD6474 300mg intervention 2: ZD6474 100 mg intervention 3: Placebo + Best Supportive Care | intervention 1: Vandetanib intervention 2: Vandetanib intervention 3: Best Supportive Care | 3 | Tainan City | N/A | Taiwan | 120.21333 | 22.99083
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 | 67 | 0 | 0 | 0 | NCT00508001 | 1COMPLETED | 2009-06-01 | 2007-07-01 | Genzyme, a Sanofi Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 622 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults. | Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults. | Bacterial Pneumonia | ceftaroline Community-acquired pneumonia CAP Streptococcus pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Chlamydophila spp Legionella ssp multi-drug resistant Streptococcus pneumoniae (MDRSP) antimicrobial resistance pneumococci beta-lactam ceftaroline fosamil ceftriaxone antibiotic | null | 2 | arm 1: Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h). arm 2: Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days intervention 2: 1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days intervention 3: Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind | intervention 1: Ceftaroline fosamil for Injection intervention 2: Ceftriaxone intervention 3: Placebo | 134 | Durham | North Carolina | United States | -78.89862 | 35.99403
Autonoma | Buenos Aires | Argentina | N/A | N/A
Mar del Plata | Buenos Aires | Argentina | -57.5562 | -38.00042
Merlo | Buenos Aires | Argentina | -58.72744 | -34.66536
Córdoba | Córdoba Province | Argentina | -64.18853 | -31.40648
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Córdoba | N/A | Argentina | -64.18853 | -31.40648
Córdoba | N/A | Argentina | -64.18853 | -31.40648
Córdoba | N/A | Argentina | -64.18853 | -31.40648
Córdoba | N/A | Argentina | -64.18853 | -31.40648
Entre Ríos | N/A | Argentina | -65.63233 | -25.44524
Granadero Baiggoria | N/A | Argentina | N/A | N/A
Paraná | N/A | Argentina | -60.52897 | -31.73271
Santa Fe | N/A | Argentina | -60.70868 | -31.64881
Santa Fe | N/A | Argentina | -60.70868 | -31.64881
Grieskirchner | Wels | Austria | N/A | N/A
Steyr | N/A | Austria | 14.42127 | 48.04274
Vienna | N/A | Austria | 16.37208 | 48.20849
Wels | N/A | Austria | 14.03333 | 48.16667
Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Rousse | N/A | Bulgaria | 25.9534 | 43.84872
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Varna | N/A | Bulgaria | 27.91667 | 43.21667
San Ignacio | Región de Valparaíso | Chile | N/A | N/A
Santiago | N/A | Chile | -70.64827 | -33.45694
Santiago | N/A | Chile | -70.64827 | -33.45694
Santiago | N/A | Chile | -70.64827 | -33.45694
Talcahuano | N/A | Chile | -73.11684 | -36.72494
Temuco | N/A | Chile | -72.59738 | -38.73628
Valdivia | N/A | Chile | -73.24589 | -39.81422
Valdivia | N/A | Chile | -73.24589 | -39.81422
Valparaíso | N/A | Chile | -71.62963 | -33.036
Aachen | N/A | Germany | 6.08342 | 50.77664
Aachen | N/A | Germany | 6.08342 | 50.77664
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Dachau | N/A | Germany | 11.43402 | 48.26
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552
Greifswald | N/A | Germany | 13.40244 | 54.08905
Halle | N/A | Germany | 11.97947 | 51.48158
Hanover | N/A | Germany | 9.73322 | 52.37052
Heidelberg | N/A | Germany | 8.69079 | 49.40768
Hofheim | N/A | Germany | 8.41385 | 49.65749
Immenhausen | N/A | Germany | 9.48017 | 51.42763
Lübeck | N/A | Germany | 10.68729 | 53.86893
Rotenburg (Wümme) | N/A | Germany | 9.41082 | 53.11125
Wuppertal | N/A | Germany | 7.14816 | 51.25627
Győr | N/A | Hungary | 17.63512 | 47.68333
Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539
Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539
Seregelyesi | N/A | Hungary | N/A | N/A
Sostoi | N/A | Hungary | N/A | N/A
Szent Instvan | N/A | Hungary | N/A | N/A
Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995
Vasvari Pal | N/A | Hungary | N/A | N/A
Bangalore | N/A | India | 77.59369 | 12.97194
Gujarat | N/A | India | N/A | N/A
Karnataka | N/A | India | N/A | N/A
Karnataka | N/A | India | N/A | N/A
Noida | N/A | India | 77.33 | 28.58
Pradesh | N/A | India | N/A | N/A
Daugavpils | N/A | Latvia | 26.53333 | 55.88333
Latvia | N/A | Latvia | N/A | N/A
Liepāja | N/A | Latvia | 21.01085 | 56.50474
Riga | N/A | Latvia | 24.10589 | 56.946
Chihuahua City | N/A | Mexico | -106.08889 | 28.63528
Chihuahua City | N/A | Mexico | -106.08889 | 28.63528
Jalisco | N/A | Mexico | -91.97499 | 16.43033
Jalisco | N/A | Mexico | -91.97499 | 16.43033
Jalisco | N/A | Mexico | -91.97499 | 16.43033
Lima | N/A | Mexico | -96.92778 | 16.77222
Sonora | N/A | Mexico | -96.63531 | 19.11219
Lima | N/A | Peru | -77.02824 | -12.04318
Lima | N/A | Peru | -77.02824 | -12.04318
Bialystok | N/A | Poland | 23.16433 | 53.13333
Bystra | N/A | Poland | 19.05973 | 49.76042
Chrzanów | N/A | Poland | 19.40203 | 50.13546
Krakow | N/A | Poland | 19.93658 | 50.06143
Krakow | N/A | Poland | 19.93658 | 50.06143
Krakow | N/A | Poland | 19.93658 | 50.06143
Krakow | N/A | Poland | 19.93658 | 50.06143
Lodz | N/A | Poland | 19.47395 | 51.77058
Lodz | N/A | Poland | 19.47395 | 51.77058
Lublin | N/A | Poland | 22.56667 | 51.25
Poznan | N/A | Poland | 16.92993 | 52.40692
Poznan | N/A | Poland | 16.92993 | 52.40692
Skierniewice | N/A | Poland | 20.15837 | 51.95485
Warsaw | N/A | Poland | 21.01178 | 52.22977
Warsaw | N/A | Poland | 21.01178 | 52.22977
Warsaw | N/A | Poland | 21.01178 | 52.22977
Warsaw | N/A | Poland | 21.01178 | 52.22977
Warsaw | N/A | Poland | 21.01178 | 52.22977
Wilkowice-Bystra | N/A | Poland | N/A | N/A
Wroclaw | N/A | Poland | 17.03333 | 51.1
Zabrze | N/A | Poland | 18.78576 | 50.32492
Zabrze | N/A | Poland | 18.78576 | 50.32492
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bucharest | N/A | Romania | 26.10626 | 44.43225
Craiova | N/A | Romania | 23.8 | 44.31667
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Smolensk | N/A | Russia | 32.04371 | 54.77944
Yaroslavl | N/A | Russia | 39.87368 | 57.62987
Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Vinnytsia | N/A | Ukraine | 28.46871 | 49.2322
Zaporizhya | N/A | Ukraine | N/A | N/A
Zhytomyr | N/A | Ukraine | 28.67913 | 50.26235 | 622 | 0 | 0 | 0 | NCT00509106 | 1COMPLETED | 2009-06-01 | 2007-07-01 | Forest Laboratories | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 112 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This was a multi-institutional, open-label, single-arm, Phase II study of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). | null | Metastatic Breast Cancer | Trastuzumab emtansine MBC Breast cancer HER2-positive breast cancer HER2 | null | 1 | arm 1: Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle. | [
0
] | 1 | [
0
] | intervention 1: Trastuzumab emtansine was provided in either a liquid or a lyophilized formulation. | intervention 1: Trastuzumab emtansine [Kadcyla] | 40 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Denver | Colorado | United States | -104.9847 | 39.73915
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Boca Raton | Florida | United States | -80.0831 | 26.35869
Davie | Florida | United States | -80.2331 | 26.06287
Jacksonville | Florida | United States | -81.65565 | 30.33218
Port Saint Lucie | Florida | United States | -80.35033 | 27.29393
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Tampa | Florida | United States | -82.45843 | 27.94752
Marietta | Georgia | United States | -84.54993 | 33.9526
Galesburg | Illinois | United States | -90.37124 | 40.94782
Waterloo | Iowa | United States | -92.34296 | 42.49276
Louisville | Kentucky | United States | -85.75941 | 38.25424
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Columbia | Missouri | United States | -92.33407 | 38.95171
Lee's Summit | Missouri | United States | -94.38217 | 38.91084
St Louis | Missouri | United States | -90.19789 | 38.62727
Livingston | New Jersey | United States | -74.31487 | 40.79593
Albany | New York | United States | -73.75623 | 42.65258
The Bronx | New York | United States | -73.86641 | 40.84985
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Eugene | Oregon | United States | -123.08675 | 44.05207
Austin | Texas | United States | -97.74306 | 30.26715
Bedford | Texas | United States | -97.14307 | 32.84402
Corpus Christi | Texas | United States | -97.39638 | 27.80058
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
El Paso | Texas | United States | -106.48693 | 31.75872
Fort Worth | Texas | United States | -97.32085 | 32.72541
Houston | Texas | United States | -95.36327 | 29.76328
Midland | Texas | United States | -102.07791 | 31.99735
Tyler | Texas | United States | -95.30106 | 32.35126
Waco | Texas | United States | -97.14667 | 31.54933
Ogden | Utah | United States | -111.97383 | 41.223
Fairfax | Virginia | United States | -77.30637 | 38.84622
Tacoma | Washington | United States | -122.44429 | 47.25288
Vancouver | Washington | United States | -122.66149 | 45.63873 | 112 | 0 | 0 | 0 | NCT00509769 | 1COMPLETED | 2009-06-01 | 2007-07-01 | Genentech, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 110 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 1FEMALE | false | The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral contraceptive (COC) on bone mineral density (BMD). | null | Contraception | null | 2 | arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic COC arm 2: Levonorgestrel (LNG) and Ethinyl Estradiol (EE), 0.150 mg LNG and 0.030 mg EE monophasic COC | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years). intervention 2: Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years). | intervention 1: NOMAC-E2 intervention 2: LNG-EE | 0 | null | 110 | 0 | 0 | 0 | NCT00511342 | 1COMPLETED | 2009-06-01 | 2006-09-01 | Organon and Co | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3,
4
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | Chronic insomnia is a major public health problem that affects about 10% of adults and is associated with serious and distressful health consequences such as depression, anxiety and reduced quality of life. Sleep medications are effective, but side effects, costs and uncertain long term efficacy call for non-pharmacologic alternatives. Mindfulness-Based Stress Reduction (MBSR), a standardized program of training in mindfulness meditation and yoga, is a promising new approach for treating chronic insomnia. MBSR was developed to facilitate adaptation to the stressors of medical illness. It is hypothesized that mindfulness training reduces arousal and unhelpful cognitions that promote and sustain chronic insomnia. The Mindfulness Versus Pharmacotherapy trial (MVP#1) is a pilot study designed to establish the feasibility and determine the optimal design for a full-scale trial comparing MBSR to prescribed sleep medication for treatment of chronic insomnia. For this pilot, we will randomize persons with primary chronic insomnia (actual sample of 30 persons) to 2 groups : 1) MBSR (8-weeks of group instruction followed by 3-months of home practice); and 2) PCT (3 mg of LUNESTA(eszopiclone) nightly for 8-weeks followed by 3-months of "as needed" use). Both groups will have telephone monitoring for side effects, adherence tracking, and objective sleep assessment by actigraphy. The primary outcomes are sleep quality, sleep quantity and insomnia severity assessed by well-validated self-report scales, objective sleep parameters measured by wrist actigraphy, depression and anxiety symptoms, health-related quality of life and workplace productivity. We hypothesize that those in the MBSR group will have improved sleep outcomes. Outcomes will be assessed at 8-weeks (the end of the active intervention phase) and 5 months follow-up. Outcomes will be compared to baseline values and measures reflecting proposed mechanisms of action to determine if clinically important impacts are likely to be obtainable in a full-scale trial. After follow-up data have been collected, participants will be invited to participate in focus groups to share their impressions of the study interventions to identify issues that could be addressed in a full-scale trial. Our long-range goal is to provide evidence-based recommendations for safe, practical and cost-effective non-pharmacologic treatment options for chronic insomnia. | The NIH's 2003 National Sleep Disorders Research Plan defines insomnia as "difficulty falling asleep, difficulty staying asleep or short sleep duration, despite adequate opportunity for sleep," and estimates that it affects 30% to 40% of adults. The prevalence of chronic insomnia, defined as sleep disturbances for 4 weeks or more, sleep disruption with daytime impairment, or regular, nightly sleep difficulty, is about 10% of the general population, with higher rates among women, older adults and clinical populations. Total direct and indirect costs of insomnia are estimated to be roughly $113 billion annually. While only about 3 million of the 70 million Americans with insomnia take prescription medications, annual prescription drug costs for insomnia exceed $2.1 billion dollars.
Mindfulness-Based Stress Reduction (MBSR), a standardized group program of training in mindfulness meditation and yoga, is a promising intervention for lifelong self-management of chronic insomnia. Mindfulness meditation training has been found to improve sleep outcomes in patients with chronic illnesses. Meditation may be defined as self-regulation of attention, and mindfulness has been described as paying attention in a particular, intentional way, moment-by-moment, without judging. MBSR originated with the Stress Reduction Clinic at the University of Massachusetts Medical Center and is currently used in over 250 clinics, hospitals, and health maintenance organizations in the US and abroad (www.umassmed.edu/cfm/srp/).
MVP#1 is a pilot study to establish feasibility, refine procedures and determine the optimal design for a planned full-scale trial. An active control drug, eszopiclone which is a widely used and FDA approved prescription sleep medication, is included in the pilot to provide a benchmark for efficacy. Outcomes will evaluated to determine if clinically important impacts are likely to be obtainable in the future full-scale trial. | Chronic Insomnia Primary Insomnia | mindfulness meditation MBSR mindfulness meditation sleep insomnia chronic insomnia primary insomnia Minnesota | null | 2 | arm 1: A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring. arm 2: A pharmacotherapy control arm (PCT Sleeping Pills) consisting of a state-of-the-art prescription sedative hypnotic, eszopiclone - brand name LUNESTA(R), at a dose of one 3 milligram (mg) pill nightly for a duration of 8 weeks followed by use as needed (same dosage) for 3 months. This drug was approved by the Food and Drug Administration as a sedative for more than short term use. | [
0,
1
] | 2 | [
5,
0
] | intervention 1: The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness. intervention 2: One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of "as needed" use | intervention 1: Mindfulness-Based Stress Reduction intervention 2: eszopiclone | 2 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 30 | 0 | 0 | 0 | NCT00515177 | 1COMPLETED | 2009-06-01 | 2007-08-01 | University of Minnesota | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 43 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | true | This study is to determine the effects of Lovaza in platelet function studies | Cardiovascular disease remains a leading cause of death in North America (1). Uncontrolled platelet activation, adhesion and aggregation initiated by vessel wall plaque rupture are thought to be responsible for acute vascular occlusion in many situations (2-5). Although many platelet inhibition drugs are available, all currently available drugs have undesirable toxicity profiles (6-8). Thus, reduction in toxicity and improved management of patients with thrombotic diseases remains an unmet medical need.
Platelet activation plays a pivotal role in the pathogenesis of acute coronary syndromes, strokes and other thrombophilic diseases. Atheromatous plaque rupture changes the shear forces of blood flowing over the injured vessel surface and also exposes collagen as well as other prothrombotic factors (9-11). As the initial hemostatic event, platelets become activated and cover the injured surface. Following platelet activation highly active substances like adenosine diphosphate (ADP) and thromboxane A2 (TxA2) are released from the platelet to promote and recruit further platelet aggregation to the injury site (12). If this process proceeds unabated, as it often does in atherosclerotic diseases, the vessel becomes occluded and infarction may follow.
Lovaza® (Reliant Pharmaceutical Inc., Liberty Corner, NJ), a commercially available formulation that contains 90 % omega-3-acid ethyl esters (46% eicosapentaenoic acid -EPA- and 38% docosohexaenoic acid -DHA-), has the potential ability to modify the recruitment of additional platelets to the growing thrombus by promoting synthesis of thromboxane A3 (TxA3), a poor platelet activator, instead of thromboxane A2, a potent platelet activator. Agents used to inhibit platelet function such as aspirin and clopidogrel are not always effective (13-16). Unfortunately, some patients do not respond to these therapeutics (17-24). Realistic numbers for patient resistance to these drugs are probably 10-15% for ASA and 20-30% for clopidogrel. Almost all resistant patients have less favorable outcomes and are unaware of this potentially life-threatening problem until a severe cardiac adverse event occurs. Lovaza® may add additional therapeutic benefit to these patients.(25,26) Beyond the occasional patient with complaints of eructation or a "fishy" taste in their mouth, Lovaza® has a benign toxicity profile. If Lovaza® can be shown to have a clinically relevant anti-platelet effect, it may have a use to either replace or reduce the dose of more toxic anti-platelet agents.
The proposed biochemical mechanism for the anti-platelet effect of omega n3 fatty acids is based on modifications in platelet prostaglandin metabolism (27-31). Cellular membranes are primarily composed of phospholipids (PL). The backbone of PL's is glycerol. The glycerol hydroxyl groups in position 1 and 2 bind two fatty acid molecules through formation of ester bonds (31). The third hydroxyl binds the so-called head group, which may be choline, inositol, ethanolamine or serine. At least in the case of platelets the fatty acid at the C-2 position is often the unsaturated arachidonic fatty acid (an omega n6 fatty acid). When Lovaza® is ingested (an omega n3 fatty acid), the unsaturated fatty acid at the C2 position can be DHA or EPA. Several important differences result from this substitution including an important effect on platelet function. As part of the platelet activation process, phospholipase A2 clips the fatty acid at the C-2 position, either arachidonic acid or DHA/EPA (31). In the case of the platelet, the fatty acid is then metabolized through an enzyme called COX-1 to a thromboxane (32-35). When the fatty acid is arachidonic acid, thromboxane A2 is synthesized (TxA2). TxA2 is a very potent platelet activator and vasoconstrictor. In the case of DHA or EPA, a series 3 TxA3 is synthesized, a poor platelet activator and vasoconstrictor (32-35). Production of TxA3 underlies the potential anti-platelet effect of Lovaza®.
The second effect of DHA inclusion in PL's is a newly discovered alteration in the cell membrane structure. It is now well established that DHA promotes "lipid raft" formation in cellular membranes (36-38). These rafts, primarily composed of sphingomyelin and cholesterol, form the sites where some transmembrane proteins can be inserted into the membrane. These transmembrane proteins may be sites for ion channels or receptors that define important cellular functions and can be a means to activate cells. Thus, DHA's ability to promote raft formation may have a profound beneficial effect on platelet function.
Since it is the Lovaza®-alteration of the platelet membrane that leads to its clinical benefit, assays to determine how the lipid composition of the platelet membrane changes after ingestion of Lovaza® will be carried out. The concept of these experiments is fairly simple. A standard well-established 1H NMR method will be used to detect changes in the lipid composition of the platelet membrane as a function of the Lovaza® dose (39-41). From these experiments we will be able to prove that DHA or EPA from Lovaza® is actually directly incorporated into a platelet membrane | Cardiovascular Disease Bleeding | Platelet Cardiovascular Lipid Fish Oil Omega 3 DHA EPA Bleeding Clotting platelet function Lipid profile Weight and Bleeding risk | null | 4 | arm 1: Patient is not on Aspirin, Clopidogrel, or Warfarin and is taking escalating doses of study drug. arm 2: Patient is on regular dose of Aspirin ( \< or = 325mg). Patient is not taking Clopidogrel or Warfarin and is taking the escalating doses of Lovaza arm 3: Patient is taking regularly 75mg of clopidogrel daily and Aspirin (\< or = 325mg) and not taking Warfarin and is taking the escalating doses of Lovaza arm 4: Patient is regularly taking Warfarin daily and Aspirin (\< or = 325mg)and is not taking Clopidogrel and is taking the escalating doses of Lovaza | [
1,
1,
1,
1
] | 1 | [
0
] | intervention 1: First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily | intervention 1: Lovaza | 0 | null | 43 | 0 | 0 | 0 | NCT00515541 | 1COMPLETED | 2009-06-01 | 2007-09-01 | Invitrox | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 15 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Objectives:
Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk myelodysplastic syndromes (MDS).
Secondary: To evaluate response duration, survival and side effects of the treatment. | MDS is a disease that produces low blood counts and may cause anemia, infections, and/or bleeding. Erythropoietin and Granulocyte colony-stimulating factor (G-CSF or GCSF) are drugs that stimulate the production of red cells and white cells. Prednisone and cyclosporin are drugs that work against MDS by affecting your immune system.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Routine blood tests (between 4-6 tablespoons) will be performed. You will have a bone marrow aspiration. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will receive erythropoietin as an injection under the skin once a week and G-CSF as an injection under the skin 1-2 times a week for as long as you respond well to treatment. You will take prednisone by mouth every day for a month and cyclosporin tablets by mouth every day for 6 months.
During this study, you will need to visit your doctor for a physical exam and measurement of your vital signs. The frequency of doctor visits will vary depending on your physical condition, but will be required at least once every 3 months.
Blood tests (about 2 teaspoons) will be done about every 1-2 weeks during the first 12 weeks of treatment, then every 2 to 4 weeks for the remainder of the study. The blood samples will be collected for routine lab tests. Periodic (every 3 to 6 months) bone marrow samples will also be taken to check cells related to the disease before, during, and after completion of this study.
You will be taken off study if the disease gets worse or intolerable side effects occur.
This is an investigational study. All drugs are FDA approved and commercially available. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson. | Myelodysplastic Syndrome | Myelodysplastic Syndrome MDS Erythropoietin Darbepoetin alfa Aranesp Erythropoiesis stimulating protein G-CSF Filgrastim Neupogen Prednisone Cyclosporin A Sandimmune CYA Cyclosporine | null | 1 | arm 1: Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice a week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 40,000 units injected under the skin (SQ) weekly intervention 2: 300 mg (tablets) by mouth daily for 6 months intervention 3: 300 mcg injected under the skin (SQ) two times per week intervention 4: 60 mg per day for 7 days, taper over 1 month | intervention 1: Erythropoietin intervention 2: Cyclosporin A intervention 3: G-CSF intervention 4: Prednisone | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 14 | 0 | 0 | 0 | NCT00520468 | 1COMPLETED | 2009-06-01 | 2004-06-01 | M.D. Anderson Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 4 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined. | DepoCyt is a sustained-release formulation of the chemotherapy drug, cytarabine (Ara-C), which is used for the treatment of patients with lymphomatous or leukemic meningitis, a complication of lymphoma/leukemia that is characterized by the spread of cancer to the central nervous system.
DepoCyt is introduced into the spinal fluid, through a needle inserted into the spinal canal or through a reservoir placed under the scalp by a neurosurgeon. DepoCyt will be given every two weeks i.e. week 1 and week 3 initially. After the second dose, a lumbar puncture will be done to check the spinal fluid for cancer cells. If there has been a good response, DepoCyt will be given every 14 days for 6 doses i.e., weeks 5, 7, 9, 11, 13, 15 and then every 28 days for six doses i.e., weeks 19, 23, 27, 31, 35, and 39. Blood tests and lumbar punctures will be done throughout the study. | Neoplastic Meningitis Lymphoma, B Cell | Lymphoma Leukemia Leukemic Meningitis Lymphomatous Meningitis | null | 2 | arm 1: Subjects with Lymphomatous Meningitis arm 2: Subjects with Leukemic Meningitis | [
0,
0
] | 1 | [
0
] | intervention 1: 50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses | intervention 1: cytarabine liposome injection | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 4 | 0 | 0 | 0 | NCT00523939 | 6TERMINATED | 2009-06-01 | 2006-06-01 | Duke University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 368 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of the study was to compare the efficacy and safety of 4 weeks treatment with bisacodyl (Dulcolax) tablets 10 mg to placebo in patients with functional constipation. In addition, the effect of treatment on quality of life and general health status was evaluated. | null | Constipation | null | 2 | arm 1: patient to receive two enteric-coated tablets containing 5 mg bisacodyl arm 2: patient to receive two placebo-to-match enteric-coated tablets 5 mg bisacodyl | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2 x 5 mg bisacodyl once daily intervention 2: Placebo-to-match bisacodyl 10 mg (2 x 5 mg) once daily | intervention 1: Bisacodyl 10 mg intervention 2: Placebo | 27 | Addlestone | N/A | United Kingdom | -0.49353 | 51.37135
Ash Vale, Aldershot | N/A | United Kingdom | N/A | N/A
Ashford | N/A | United Kingdom | 0.87376 | 51.14648
Atherstone | N/A | United Kingdom | -1.54693 | 52.57536
Bedworth | N/A | United Kingdom | -1.46909 | 52.4791
Bennetthorpe, Doncaster | N/A | United Kingdom | -1.13116 | 53.52285
Bexhill-on-Sea | N/A | United Kingdom | 0.47095 | 50.85023
Blackpool | N/A | United Kingdom | -3.05 | 53.81667
Burbage | N/A | United Kingdom | -1.67087 | 51.35184
Cardiff | N/A | United Kingdom | -3.18 | 51.48
Chesterfield | N/A | United Kingdom | -1.41667 | 53.25
Chippenham | N/A | United Kingdom | -2.12472 | 51.46
Chorley | N/A | United Kingdom | -2.61667 | 53.65
Dundee | N/A | United Kingdom | -2.97489 | 56.46913
Edgbaston, Birmingham | N/A | United Kingdom | N/A | N/A
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515
Liverpool | N/A | United Kingdom | -2.97794 | 53.41058
Manchester | N/A | United Kingdom | -2.23743 | 53.48095
Midsomer Norton | N/A | United Kingdom | -2.48591 | 51.28567
Newtonabbey | N/A | United Kingdom | N/A | N/A
Paignton | N/A | United Kingdom | -3.56789 | 50.43565
Royal Leamington Spa | N/A | United Kingdom | -1.52 | 52.2852
Slough | N/A | United Kingdom | -0.59541 | 51.50949
Sunbury-on-Thames | N/A | United Kingdom | -0.41817 | 51.40424
Swindon | N/A | United Kingdom | -1.78116 | 51.55797
Warminster | N/A | United Kingdom | -2.17873 | 51.20434
Wolverhampton | N/A | United Kingdom | -2.12296 | 52.58547 | 368 | 0 | 0 | 0 | NCT00526097 | 1COMPLETED | 2009-06-01 | 2007-09-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 222 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | false | The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis. | This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis. | Osteoporosis | osteoporosis postmenopausal bone loss | null | 5 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None | [
2,
0,
0,
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: teriparatide 20 µg subcutaneous daily intervention 2: Placebo subcutaneous daily intervention 3: BA058 20 µg subcutaneous daily intervention 4: BA058 40 µg subcutaneous daily intervention 5: BA058 80 µg subcutaneous daily | intervention 1: teriparatide intervention 2: Placebo intervention 3: BA058 20 µg intervention 4: BA058 40 µg intervention 5: BA058 80 µg | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 221 | 0 | 0 | 0 | NCT00542425 | 1COMPLETED | 2009-06-01 | 2007-04-01 | Radius Health, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon, CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily) plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals. | null | Myelodysplastic Syndromes | null | 1 | arm 1: Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 1 gm twice daily orally until end of study. intervention 2: 10 mg/day orally until end of study. intervention 3: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks. | intervention 1: Mycophenolate mofetil intervention 2: Prednisone intervention 3: Erythropoietin Beta | 8 | Barakaldo | N/A | Spain | -2.98813 | 43.29639
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Cadiz | N/A | Spain | -6.2891 | 36.52672
Madrid | N/A | Spain | -3.70256 | 40.4165
Palma de Mallorca | N/A | Spain | 2.65024 | 39.56939 | 10 | 0 | 0 | 0 | NCT00551291 | 1COMPLETED | 2009-06-01 | 2007-08-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 340 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. This trial is designed to show non-inferiority of parecoxib related to ketoprofen. | null | Pain | Renal Colic Pain Urinary Tract Colic | null | 2 | arm 1: Ketoprofen plus placebo parecoxib arm 2: Parecoxib plus placebo ketoprofen | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection intervention 2: Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period | intervention 1: Ketoprofen 100mg intervention 2: Parecoxib 40mg | 17 | Rio de Janeiro | Rio de Janeiro | Brazil | -43.18223 | -22.90642
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Ribeirão Preto | São Paulo | Brazil | -47.81028 | -21.1775
Ribeirão Preto | São Paulo | Brazil | -47.81028 | -21.1775
São Bernardo do Campo | São Paulo | Brazil | -46.565 | -23.69389
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
Vila Mariana - São Paulo | São Paulo | Brazil | N/A | N/A
Providencia | Santiago, RM | Chile | -70.60454 | -33.43107
Alajuela | Alajuela Province | Costa Rica | -84.21275 | 10.01723
Desamparados | Provincia de San José | Costa Rica | -84.06345 | 9.89747
San José | Provincia de San José | Costa Rica | -84.08489 | 9.93388
Quito | Pichincha | Ecuador | -78.52495 | -0.22985
San Pedro Sula | San Pedro Sula | Honduras | -88.02588 | 15.50585
Lima | Lima Province | Peru | -77.02824 | -12.04318
Lima | Lima Province | Peru | -77.02824 | -12.04318 | 338 | 0 | 0 | 0 | NCT00553605 | 1COMPLETED | 2009-06-01 | 2007-06-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 2,487 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions. | null | Obesity Type 2 Diabetes | Obesity, Type 2 diabetes | null | 3 | arm 1: high dose experimental treatment arm 2: mid dose experimental treatment arm 3: Placebo | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: phentermine 15 mg and topiramate 92 mg, po once daily intervention 2: phentermine 7.5 mg and topiramate 46 mg, po once daily intervention 3: placebo | intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: VI-0521 | 6 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Ridgefield | Connecticut | United States | -73.49818 | 41.28148
New York | New York | United States | -74.00597 | 40.71427
Durham | North Carolina | United States | -78.89862 | 35.99403
Toledo | Ohio | United States | -83.55521 | 41.66394
Austin | Texas | United States | -97.74306 | 30.26715 | 2,485 | 0 | 0 | 0 | NCT00553787 | 1COMPLETED | 2009-06-01 | 2007-11-01 | VIVUS LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 63 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks. | null | Tourette Syndrome | null | 2 | arm 1: None arm 2: None | [
5,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: pramipexole immediate release (IR) intervention 2: Placebo | 16 | Bradenton | Florida | United States | -82.57482 | 27.49893
Tampa | Florida | United States | -82.45843 | 27.94752
Columbus | Georgia | United States | -84.98771 | 32.46098
Chicago | Illinois | United States | -87.65005 | 41.85003
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
Manhasset | New York | United States | -73.69957 | 40.79788
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
Orangeburg | New York | United States | -73.94958 | 41.04649
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Providence | Rhode Island | United States | -71.41283 | 41.82399
Memphis | Tennessee | United States | -90.04898 | 35.14953
Houston | Texas | United States | -95.36327 | 29.76328
Norfolk | Virginia | United States | -76.28522 | 36.84681
Hanover | N/A | Germany | 9.73322 | 52.37052
Ulm | N/A | Germany | 9.99155 | 48.39841 | 63 | 0 | 0 | 0 | NCT00558467 | 1COMPLETED | 2009-06-01 | 2008-01-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2,
3
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa. | CF is a gentic disease resulting from mutations in a 230 kb gene on chromosome 7 known as the cystic fibrosis transmembrane conductance regulator (CFTR). Study subjects with CF manifest pathological changes in a variety or organs that express CFTR. The lungs are frequently affected, the sequelae being chronic infections and airway inflammation. The principal goal of both treatment of subjects with CF is to slow the chronic deterioration of lung function.
Study subjects will be randomized to receive either study drug or placebo (1.5% NaCl) by inhalation via a PARI eFlow nebulizer. Each subject will complete 28 days of daily dosing. All study patients will be followed for safety, pharmacokinetics, clinical and microbiologic activity for 56 days post completion of study treatment. For the two lower doses (70 mg and 140 mg): patients received drug for 28 days, followed by a 28 day safety evaluation. For 560 mg: patients received drug for 28 days, followed by a 56 day safety evaluation. The total study period will be up to 84 days, with screening visit occurring within the preceding 14 days prior to study day 1. Patients will be clinically evaluated during the first 48 hours post first study dose and weekly for the 28 day treatment period and during the follow up visits at study days 35, 42, 49, 56, 70 and 85 days to determine safety and tolerability, pharmacokinetics (PK) and clinical and microbiologic activity.
Clinical laboratory parameters, audiology testing, clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and tolerability of Arikayce™ compared to placebo. Serum, urine and sputum specimens will be collected at periodic intervals to assess PK. Additionally, sputum samples will be collected to determine changes in bacterial density. Pulmonary function testing and CFQ-R measurements will be assessed at selected time points throughout the study. An exploratory evaluation of a Cystic Fibrosis Symptom Diary (CFSD) will also be implemented. Arikace™,Arikayce™, Liposomal Amikacin for Inhalation (LAI), and Amikacin Liposome Inhalation Suspension (ALIS) may be used interchangeably throughout this study and other studies evaluating amikacin liposomal inhalation suspension. | Cystic Fibrosis | Cystic Fibrosis Respiratory Infections Pulmonary Cystic Fibrosis CFTR | null | 5 | arm 1: Arikayce™ at 560 mg Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo. arm 2: Matching placebo for 560 mg Subjects randomized 2:1 to receive Arikayce 560 mg or Placebo. arm 3: Arikayce™ at 70 mg Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo. arm 4: Arikayce™ at 140 mg Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo. arm 5: Matching placebo for 70 mg/140 mg Subjects randomized 1:1:1 to receive Arikayce 70 mg, Arikayce 140 mg or Placebo. | [
1,
2,
1,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Arikayce™ at 560 mg
Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 2:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 2: Matching placebo
Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 2:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 3: Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 4: Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 5: Matching placebo
Subjects will be randomly assigned to study drug dose of of Arikayce™ or placebo in accordance with a code provided by the Sponsor/CRO. Randomization will be made in a 1:1:1 allocation between Arikayce™ and placebo. They will be blinded whether they receive Arikayce™ or Placebo Study subjects will receive Arikayce™ or placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. | intervention 1: Arikayce™ 560 mg intervention 2: Placebo for 560 mg intervention 3: Arikayce™ 70 mg intervention 4: Arikayce™ 140 mg intervention 5: Placebo for 70 mg / 140 mg | 19 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Iowa City | Iowa | United States | -91.53017 | 41.66113
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Jackson | Mississippi | United States | -90.18481 | 32.29876
St Louis | Missouri | United States | -90.19789 | 38.62727
Morristown | New Jersey | United States | -74.48154 | 40.79677
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Rochester | New York | United States | -77.61556 | 43.15478
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Sioux Falls | South Dakota | United States | -96.70033 | 43.54997
Seattle | Washington | United States | -122.33207 | 47.60621 | 41 | 0 | 0 | 0 | NCT00558844 | 1COMPLETED | 2009-06-01 | 2008-01-01 | Insmed Incorporated | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 60 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | true | To evaluate if supplementation of zeaxanthin (with or without Lutein) is beneficial to patients with early and moderate Atrophic Age Related Macular Degeneration. | To evaluate whether or not zeaxanthin supplementation raises macular pigment optical density (MPOD). Previous research has shown MPOD to mirror visual benefits for patients with age related atrophic macular degeneration (AMD) having visual symptoms (decreased visual acuity, contrast sensitivity, photostress glare recovery and National Eye Institute Visual Function Questionnaire 25 scores), but lower risk National Eye Institute (NEI) / Age Related Eye Disease Study (AREDS) characteristics. | Age Related Macular Degeneration Cognition Disorders | Macular Pigment Optical Density Skin Carotenoids Lipofuscin Photostress (Glare Recovery) Visual Field Progression Contrast Sensitivity Color Vision Cognitive Function | null | 3 | arm 1: 9 mg of Lutein for 12 months arm 2: 3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months arm 3: 3R 3'R Zeaxanthin 8 mg per day during 12 months | [
2,
1,
1
] | 3 | [
0,
7,
7
] | intervention 1: 8 mg per day during 12 months intervention 2: 9 mg of Lutein during 12 months intervention 3: 8 mg of lutein and 8 mg of Zeaxanthin administered during 12 months | intervention 1: 3R 3'R Zeaxanthin intervention 2: Lutein intervention 3: Lutein and Zeaxanthin | 1 | North Chicago | Illinois | United States | -87.84118 | 42.32558 | 60 | 0 | 0 | 0 | NCT00564902 | 1COMPLETED | 2009-06-01 | 2007-11-01 | Chrysantis, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,496 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity. | Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than naltrexone alone, bupropion SR alone or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia. | Obesity Overweight | Obesity | null | 2 | arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day with ancillary therapy arm 2: Placebo with ancillary therapy | [
0,
2
] | 3 | [
0,
0,
5
] | intervention 1: None intervention 2: None intervention 3: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling | intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/day intervention 2: Placebo intervention 3: Ancillary therapy | 36 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Carmichael | California | United States | -121.32828 | 38.61713
Fresno | California | United States | -119.77237 | 36.74773
Newport Beach | California | United States | -117.92895 | 33.61891
Denver | Colorado | United States | -104.9847 | 39.73915
Waterbury | Connecticut | United States | -73.0515 | 41.55815
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Palm Harbor | Florida | United States | -82.76371 | 28.07807
Atlanta | Georgia | United States | -84.38798 | 33.749
Stockbridge | Georgia | United States | -84.23381 | 33.54428
Valparaiso | Indiana | United States | -87.06114 | 41.47309
Madisonville | Kentucky | United States | -87.49889 | 37.3281
Boston | Massachusetts | United States | -71.05977 | 42.35843
Milford | Massachusetts | United States | -71.51617 | 42.13982
Okemos | Michigan | United States | -84.42747 | 42.72226
Brooklyn Center | Minnesota | United States | -93.33273 | 45.07608
St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Dover | New Hampshire | United States | -70.87367 | 43.19786
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Manlius | New York | United States | -75.97686 | 43.00201
New York | New York | United States | -74.00597 | 40.71427
Staten Island | New York | United States | -74.13986 | 40.56233
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Kettering | Ohio | United States | -84.16883 | 39.6895
Portland | Oregon | United States | -122.67621 | 45.52345
Danville | Pennsylvania | United States | -76.61273 | 40.96342
Greer | South Carolina | United States | -82.22706 | 34.93873
Mt. Pleasant | South Carolina | United States | -79.86259 | 32.79407
Nashville | Tennessee | United States | -86.78444 | 36.16589
Dallas | Texas | United States | -96.80667 | 32.78306
Seattle | Washington | United States | -122.33207 | 47.60621 | 1,484 | 0 | 0 | 0 | NCT00567255 | 1COMPLETED | 2009-06-01 | 2007-12-01 | Orexigen Therapeutics, Inc | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 23 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals. | null | Breast Cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 15mg/kg iv on day 1 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: 2000mg/m2 po on days 1-15 of each 3 week cycle | intervention 1: bevacizumab [Avastin] intervention 2: Docetaxel intervention 3: Xeloda | 1 | Madrid | Madrid | Spain | -3.70256 | 40.4165 | 23 | 0 | 0 | 0 | NCT00576901 | 6TERMINATED | 2009-06-01 | 2007-11-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.
Hypotheses:
1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.
2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL) | null | Pancreatic Cancer | null | 2 | arm 1: subject randomized to 10ml of dehydrated alcohol arm 2: subject randomized to 20ml of dehydrated alcohol | [
5,
0
] | 1 | [
0
] | intervention 1: subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure | intervention 1: dehydrated alcohol | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 20 | 0 | 0 | 0 | NCT00578279 | 1COMPLETED | 2009-06-01 | 2007-03-01 | Indiana University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX). | null | Langerhans Cell Histiocytosis | Langerhans Cell Histiocytosis LCH 6-Thioguanine 6-TG Methotrexate MTX 94-132 | null | 1 | arm 1: MTX, 6-TG, Leucovorin | [
0
] | 3 | [
0,
0,
0
] | intervention 1: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs intervention 2: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose. intervention 3: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses) | intervention 1: Methotrexate intervention 2: 6-Thioguanine intervention 3: Leucovorin Calcium | 1 | New York | New York | United States | -74.00597 | 40.71427 | 5 | 0 | 0 | 0 | NCT00588536 | 1COMPLETED | 2009-06-01 | 1995-01-01 | Memorial Sloan Kettering Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,221 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia. | This is a randomized (patients assigned to treatment groups by chance), double-blind (patient and study staff will not know the treatment assignment) study of paliperidone palmitate compared with RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection) in adult patients with schizophrenia. The total duration of the study will be approximately 14 weeks. For those patients without source documentation of tolerability to oral (by mouth) risperidone or paliperidone Extended Release (ER) tablets, injectable RISPERDAL CONSTA or paliperidone palmitate, or those patients who were not currently taking another antipsychotic, a minimum of 4 days and a maximum of 6 days of oral paliperidone ER treatment at a dosage of 6 mg/day will be administered for tolerability testing before the first injection of double-blind (DB) study drug (paliperidone palmitate or RISPERDAL CONSTA). During the DB period, study drug will be administered to patients as an intramuscular (i.m.) injection. Paliperidone palmitate (PP) 150mg equivalent (eq) (and RISPERDAL CONSTA placebo) at Baseline (BL) (Day 1), 100mg eq at Visit (V) 4 (Day 8), 50 or 100mg eq at V7 (Day 36), and 50,100,or 150mg eq at V9 (Day 64) or RISPERDAL CONSTA (RC) 25mg at V4 and V6 (Day 22), 25 or 37.5mg at V7, and 25, 37.5, or 50mg at V9 will be given as i.m. injections. Patients in the RC group will also take risperidone tablets (1-6 mg/day) at BL for 28 days and be given an injection of PP placebo at BL, V1, V7, and V9. | Schizophrenia | Schizophrenia long-acting injectable antipsychotic medication | null | 2 | arm 1: RISPERDAL CONSTA 25-50 mg eq every 2 weeks arm 2: Paliperidone Palmitate 50-150 mg eq every 4 wks | [
1,
0
] | 2 | [
0,
0
] | intervention 1: RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period. intervention 2: PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9. | intervention 1: RISPERDAL CONSTA intervention 2: Paliperidone palmitate | 82 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Cerritos | California | United States | -118.06479 | 33.85835
Garden Grove | California | United States | -117.94145 | 33.77391
Los Angeles | California | United States | -118.24368 | 34.05223
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Flowood | Mississippi | United States | -90.13898 | 32.30959
Hollis | New York | United States | -73.76708 | 40.71344
Willoughby | Ohio | United States | -81.4065 | 41.63977
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
DeSoto | Texas | United States | -96.85695 | 32.58986
Houston | Texas | United States | -95.36327 | 29.76328
Odessa | Texas | United States | -102.36764 | 31.84568
Linz | N/A | Austria | 14.28611 | 48.30639
Salzburg | N/A | Austria | 13.04399 | 47.79941
Vienna | N/A | Austria | 16.37208 | 48.20849
Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Varna | N/A | Bulgaria | 27.91667 | 43.21667
Brno | N/A | Czechia | 16.60796 | 49.19522
Dobřany | N/A | Czechia | 13.29307 | 49.65482
Kroměříž | N/A | Czechia | 17.39312 | 49.29785
Kutná Hora | N/A | Czechia | 15.26816 | 49.94839
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Prague | N/A | Czechia | 14.42076 | 50.08804
Pärnu | N/A | Estonia | 24.49711 | 58.38588
Tallinn | N/A | Estonia | 24.75353 | 59.43696
Tartu | N/A | Estonia | 26.72509 | 58.38062
Bourges Cedex N/A | N/A | France | N/A | N/A
Dole | N/A | France | 5.48966 | 47.09225
Romans-sur-Isère | N/A | France | 5.06602 | 45.0496
Achim | N/A | Germany | 9.0263 | 53.01416
Berlin | N/A | Germany | 13.41053 | 52.52437
Bielefeld | N/A | Germany | 8.53333 | 52.03333
Bochum | N/A | Germany | 7.21648 | 51.48165
Jena | N/A | Germany | 11.5899 | 50.92878
Leipzig | N/A | Germany | 12.37129 | 51.33962
Mannheim | N/A | Germany | 8.46694 | 49.4891
München | N/A | Germany | 13.31243 | 51.60698
Stralsund | N/A | Germany | 13.0818 | 54.30911
Baja | N/A | Hungary | 18.95307 | 46.18299
Budapest | N/A | Hungary | 19.04045 | 47.49835
Gyõr | N/A | Hungary | N/A | N/A
Kalocsa | N/A | Hungary | 18.97283 | 46.52981
Nagykálló | N/A | Hungary | 21.84082 | 47.87491
Aurangabad | N/A | India | 75.34226 | 19.87757
Bangalore | N/A | India | 77.59369 | 12.97194
Chandigarh | N/A | India | 76.7884 | 30.73629
Mangalore | N/A | India | 74.85603 | 12.91723
Pune | N/A | India | 73.85535 | 18.51957
Varanasi | N/A | India | 83.01041 | 25.31668
Alytus | N/A | Lithuania | 24.04142 | 54.39635
Kaunas | N/A | Lithuania | 23.90961 | 54.90272
Klaipėda | N/A | Lithuania | 21.13912 | 55.7068
Vilnius | N/A | Lithuania | 25.2798 | 54.68916
Bełchatów | N/A | Poland | 19.35671 | 51.36883
Bytom Na | N/A | Poland | N/A | N/A
Chełmno | N/A | Poland | 18.4251 | 53.34855
Gdynia Na | N/A | Poland | N/A | N/A
Katowice Woj Slaskie | N/A | Poland | N/A | N/A
Krakow Na | N/A | Poland | N/A | N/A
Lubliniec | N/A | Poland | 18.6844 | 50.66897
Piekary Slaskie Na | N/A | Poland | N/A | N/A
Skorzewo Na | N/A | Poland | N/A | N/A
Warszawa Na | N/A | Poland | N/A | N/A
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow Russia | N/A | Russia | N/A | N/A
Nizny Novgorod | N/A | Russia | N/A | N/A
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saratov | N/A | Russia | 46.00861 | 51.54056
Yaroslavl | N/A | Russia | 39.87368 | 57.62987
Barcelona | N/A | Spain | 2.15899 | 41.38879
Madrid | N/A | Spain | -3.70256 | 40.4165
San Juan | N/A | Spain | -1.16667 | 39.53333
Dnipro | N/A | Ukraine | 35.04066 | 48.46664
Donetsk | N/A | Ukraine | 37.80224 | 48.023
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kiev | N/A | Ukraine | 30.5238 | 50.45466
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Odesa | N/A | Ukraine | 30.74383 | 46.48572
Simferopol | N/A | Ukraine | 34.11079 | 44.95719 | 1,214 | 0 | 0 | 0 | NCT00589914 | 1COMPLETED | 2009-06-01 | 2007-03-01 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 45 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy. | null | Epilepsy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 1 | [
0
] | intervention 1: 1 Dose | intervention 1: Clonazepam | 6 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Bethesda | Maryland | United States | -77.10026 | 38.98067
New York | New York | United States | -74.00597 | 40.71427
Columbus | Ohio | United States | -82.99879 | 39.96118
Dallas | Texas | United States | -96.80667 | 32.78306
Tampere | N/A | Finland | 23.78712 | 61.49911 | 11 | 0 | 0 | 0 | NCT00594945 | 1COMPLETED | 2009-06-01 | 2007-12-01 | Jazz Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 36 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer. | The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, we believe that achieving a 30% freedom from clinical progression (PFS) (not including PSA progression) at 12 weeks represents biologically active therapy. Sunitinib malate (Sutent) represents a tolerable and convenient form of therapy with the potential for improving outcomes in AIPC. | Metastatic Prostate Cancer | null | 1 | arm 1: Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles) | [
0
] | 1 | [
0
] | intervention 1: 50 mg/day orally each of Days 1-28 of each 6 week cycle | intervention 1: Sunitinib | 45 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Torrington | Connecticut | United States | -73.12122 | 41.80065
Ocala | Florida | United States | -82.14009 | 29.1872
Niles | Illinois | United States | -87.80284 | 42.01892
Terre Haute | Indiana | United States | -87.41391 | 39.4667
Columbia | Maryland | United States | -76.83942 | 39.24038
Westminster | Maryland | United States | -76.99581 | 39.57538
Columbia | Missouri | United States | -92.33407 | 38.95171
Saint Joseph | Missouri | United States | -94.84663 | 39.76861
St Louis | Missouri | United States | -90.19789 | 38.62727
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Hooksett | New Hampshire | United States | -71.46507 | 43.09675
Santa Fe | New Mexico | United States | -105.9378 | 35.68698
Albany | New York | United States | -73.75623 | 42.65258
Rochester | New York | United States | -77.61556 | 43.15478
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Kettering | Ohio | United States | -84.16883 | 39.6895
Kingston | Pennsylvania | United States | -75.89686 | 41.26175
Greenville | South Carolina | United States | -82.39401 | 34.85262
Abilene | Texas | United States | -99.73314 | 32.44874
Amarillo | Texas | United States | -101.8313 | 35.222
Arlington | Texas | United States | -97.10807 | 32.73569
Austin | Texas | United States | -97.74306 | 30.26715
Beaumont | Texas | United States | -94.10185 | 30.08605
Bedford | Texas | United States | -97.14307 | 32.84402
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Denton | Texas | United States | -97.13307 | 33.21484
El Paso | Texas | United States | -106.48693 | 31.75872
Fort Worth | Texas | United States | -97.32085 | 32.72541
Midland | Texas | United States | -102.07791 | 31.99735
Odessa | Texas | United States | -102.36764 | 31.84568
Paris | Texas | United States | -95.55551 | 33.66094
San Antonio | Texas | United States | -98.49363 | 29.42412
Sugar Land | Texas | United States | -95.63495 | 29.61968
Waco | Texas | United States | -97.14667 | 31.54933
Webster | Texas | United States | -95.11826 | 29.53773
Norfolk | Virginia | United States | -76.28522 | 36.84681
Salem | Virginia | United States | -80.05476 | 37.29347
Edmonds | Washington | United States | -122.37736 | 47.81065
Seattle | Washington | United States | -122.33207 | 47.60621
Vancouver | Washington | United States | -122.66149 | 45.63873
Yakima | Washington | United States | -120.5059 | 46.60207 | 35 | 0 | 0 | 0 | NCT00599313 | 1COMPLETED | 2009-06-01 | 2007-03-01 | US Oncology Research | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 111 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study was to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). All study related care was provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation was 28 weeks. | This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate the efficacy and safety of doxercalciferol given orally, once daily for 24 weeks to participants with moderate to severe chronic plaque psoriasis. Participants were randomized and stratified by site and Psoriasis Area Severity Index (PASI) score to one of three active treatment groups or to the placebo group. | Moderate to Severe Chronic Plaque Psoriasis | psoriasis psoriasis vulgaris plaque psoriasis chronic plaque psoriasis | null | 4 | arm 1: Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24. arm 2: Doxercalciferol 5 mcg capsules orally once daily up to Week 24. arm 3: Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24. arm 4: Placebo matching to doxercalciferol capsules orally once daily up to Week 24. | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Doxercalciferol intervention 2: Placebo | 19 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Hot Springs | Arizona | United States | N/A | N/A
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Irvine | California | United States | -117.82311 | 33.66946
Santa Monica | California | United States | -118.49138 | 34.01949
Alpharetta | Georgia | United States | -84.29409 | 34.07538
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Andover | Massachusetts | United States | -71.137 | 42.65843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Troy | Michigan | United States | -83.14993 | 42.60559
West Bloomfield | Michigan | United States | -83.38356 | 42.56891
St Louis | Missouri | United States | -90.19789 | 38.62727
East Windsor | New Jersey | United States | -74.54043 | 40.268
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Stony Brook | New York | United States | -73.14094 | 40.92565
Greer | South Carolina | United States | -82.22706 | 34.93873
Nashville | Tennessee | United States | -86.78444 | 36.16589
San Antonio | Texas | United States | -98.49363 | 29.42412
Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 111 | 0 | 0 | 0 | NCT00601107 | 1COMPLETED | 2009-06-01 | 2008-04-01 | Genzyme, a Sanofi Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 89 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as perillyl alcohol, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing. It is not yet known which dose of topical perillyl alcohol is more effective in stopping the development of cancer in sun damaged skin.
PURPOSE: This randomized phase II trial is studying high-dose topical perillyl alcohol to see how well it works compared with low-dose topical perillyl alcohol in treating patients with sun damaged skin and actinic keratoses. | OBJECTIVES:
Primary
* To determine if topical administration of perillyl alcohol (POH) cream can reverse actinic damage as evidenced by normalization of quantitative skin histopathology scores in skin tissue biopsy samples from patients with moderate to severe sun damage.
Secondary
* To determine if topical POH can be administered safely to the forearms of these patients.
OUTLINE: Patients are randomized to 1 of 3 arms.
* Placebo: Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
* Low Dose: Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
* High Dose: Patients apply POH cream (0.76%) as in arm II. Patients undergo tissue sampling of the right or left dorsal forearm and of physician-selected representative actinic keratoses (AK) at baseline and after completion of study therapy. Tissue samples are assessed for changes in patterns of biomarker expression (i.e., p53, apoptosis, c-Fos histopathology) and karyometry. After completion of study therapy, patients undergo tissue sampling of the opposite forearm as well as blood sample collection to determine perillyl alcohol (POH) levels in blood and biopsy samples. Urine is also collected and analyzed for safety at the end of treatment. Digital photographs of the forearms and hands are obtained at baseline and after 3 months of study treatment. Optical coherence tomography imaging is also performed on pre- and post-biopsy sites to quantify the effect of POH on sun damage and AK in skin.
After completion of study treatment, patients are followed monthly. | Precancerous Condition | actinic keratosis | null | 3 | arm 1: Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity. arm 2: Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity. arm 3: Patients apply perillyl alcohol (POH) cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity. | [
2,
0,
0
] | 2 | [
0,
10
] | intervention 1: Applied as topical cream intervention 2: Applied as topical cream | intervention 1: perillyl alcohol intervention 2: placebo | 1 | Tucson | Arizona | United States | -110.92648 | 32.22174 | 83 | 0 | 0 | 0 | NCT00608634 | 1COMPLETED | 2009-06-01 | 2004-05-01 | University of Arizona | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 137 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery | null | Dry Eye Syndromes | LASIK | null | 2 | arm 1: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) arm 2: Artificial Tears (REFRESH ENDURA®) | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery intervention 2: REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery | intervention 1: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) intervention 2: Artificial Tears REFRESH ENDURA® | 1 | Overland Park | Kansas | United States | -94.67079 | 38.98223 | 137 | 0 | 0 | 0 | NCT00611403 | 1COMPLETED | 2009-06-01 | 2007-12-01 | Allergan | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 1FEMALE | false | The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.
This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.
The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized. | null | Pain Surgical Abortion | Pain associated with first trimester surgical abortion | null | 2 | arm 1: Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion arm 2: Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion | [
1,
0
] | 2 | [
0,
0
] | intervention 1: paracervical block with lidocaine intervention 2: paracervical block with ketorolac and lidocaine | intervention 1: lidocaine intervention 2: ketorolac and lidocaine | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 50 | 0 | 0 | 0 | NCT00617097 | 1COMPLETED | 2009-06-01 | 2008-01-01 | Johns Hopkins University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 606 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia | The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries | Bacterial Pneumonia | ceftaroline Community-acquired pneumonia CAP IV (intravenous) Streptococcus pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Chlamydophila spp Legionella spp Multi-drug resistant Streptococcus pneumoniae (MDRSP) antimicrobial resistance pneumococci Ceftriaxone bacteria ß-lactam beta-lactam antibiotic | null | 2 | arm 1: Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism. arm 2: Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism. | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days intervention 2: 1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days intervention 3: Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind intervention 4: In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism. | intervention 1: Ceftaroline fosamil for Injection intervention 2: IV Ceftriaxone intervention 3: Placebo intervention 4: Clarithromycin | 168 | Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | California | United States | -118.14452 | 34.14778
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Orlando | Florida | United States | -81.37924 | 28.53834
Fort Gordon | Georgia | United States | -82.16206 | 33.42097
Peoria | Illinois | United States | -89.58899 | 40.69365
Baltimore | Maryland | United States | -76.61219 | 39.29038
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Butte | Montana | United States | -112.53474 | 46.00382
Akron | Ohio | United States | -81.51901 | 41.08144
Houston | Texas | United States | -95.36327 | 29.76328
Buenos Aires | C.a.b.a. | Argentina | -58.37723 | -34.61315
San Miguel de Tucumán | Tucumán Province | Argentina | -65.21051 | -26.81601
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Vicente López | N/A | Argentina | -58.4737 | -34.52947
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Goiânia | G.o. | Brazil | -49.25389 | -16.67861
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
São José do Rio Preto | São Paulo | Brazil | -49.37944 | -20.81972
Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083
Belo Horizonte MG | N/A | Brazil | N/A | N/A
Campinas | N/A | Brazil | -47.06083 | -22.90556
Curitiba-PR | N/A | Brazil | N/A | N/A
Juiz de Fora | N/A | Brazil | -43.35028 | -21.76417
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
São Paulo | N/A | Brazil | -46.63611 | -23.5475
São Paulo | N/A | Brazil | -46.63611 | -23.5475
Burgas | N/A | Bulgaria | 27.46781 | 42.50606
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Varna | N/A | Bulgaria | 27.91667 | 43.21667
Tallinn | N/A | Estonia | 24.75353 | 59.43696
Tallinn | N/A | Estonia | 24.75353 | 59.43696
Tartu | N/A | Estonia | 26.72509 | 58.38062
Annecy | N/A | France | 6.12565 | 45.90878
Argenteuil | N/A | France | 2.24744 | 48.94788
Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341
Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Tbilisi | N/A | Georgia | 44.83412 | 41.69143
Lindenberger | State of Berlin | Germany | N/A | N/A
Berlin | N/A | Germany | 13.41053 | 52.52437
Bochum | N/A | Germany | 7.21648 | 51.48165
Bochum | N/A | Germany | 7.21648 | 51.48165
Erfurt | N/A | Germany | 11.03283 | 50.9787
Heppenheim an der Bergstrasse | N/A | Germany | 8.63206 | 49.64145
Lich | N/A | Germany | 8.81567 | 50.52085
Lübeck | N/A | Germany | 10.68729 | 53.86893
Lüdenscheid | N/A | Germany | 7.6273 | 51.21977
Paderborn | N/A | Germany | 8.75439 | 51.71905
Schkeuditz | N/A | Germany | 12.22141 | 51.39678
Ulm | N/A | Germany | 9.99155 | 48.39841
Wiesbaden | N/A | Germany | 8.24932 | 50.08258
Tatabánya | Szanatorium | Hungary | 18.39325 | 47.58494
Budapest | N/A | Hungary | 19.04045 | 47.49835
Mátraháza | N/A | Hungary | 19.97981 | 47.87124
Miskolc | N/A | Hungary | 20.77806 | 48.10306
Pécs | N/A | Hungary | 18.23083 | 46.0725
Sopron | N/A | Hungary | 16.59049 | 47.68501
Tatabánya | N/A | Hungary | 18.39325 | 47.58494
Törökbálint | N/A | Hungary | 18.91356 | 47.42931
Vellore | Tamil Nadu | India | 79.13255 | 12.9184
Kaunas | N/A | Lithuania | 23.90961 | 54.90272
Kaunas | N/A | Lithuania | 23.90961 | 54.90272
Klaipėda | N/A | Lithuania | 21.13912 | 55.7068
Klaipėda | N/A | Lithuania | 21.13912 | 55.7068
Šiauliai | N/A | Lithuania | 23.31667 | 55.93333
Vilnius | N/A | Lithuania | 25.2798 | 54.68916
Johor Bahru | Johor | Malaysia | 103.7578 | 1.4655
Cheras | Kuala Lumpur | Malaysia | N/A | N/A
George Town | Pulau Pinang | Malaysia | 100.33543 | 5.41123
Kedah | N/A | Malaysia | N/A | N/A
Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412
Będzin | N/A | Poland | 19.12565 | 50.32607
Brzesku | N/A | Poland | N/A | N/A
Bytom | N/A | Poland | 18.93282 | 50.34802
Chodzież | N/A | Poland | 16.9198 | 52.99505
Częstochowa | N/A | Poland | 19.12409 | 50.79646
Katowice-Ochojec | N/A | Poland | N/A | N/A
Krakow | N/A | Poland | 19.93658 | 50.06143
Lublin | N/A | Poland | 22.56667 | 51.25
Lublin | N/A | Poland | 22.56667 | 51.25
Poznan | N/A | Poland | 16.92993 | 52.40692
Poznan | N/A | Poland | 16.92993 | 52.40692
Tychy | N/A | Poland | 18.96641 | 50.13717
Warsaw | N/A | Poland | 21.01178 | 52.22977
Warsaw | N/A | Poland | 21.01178 | 52.22977
Warsaw | N/A | Poland | 21.01178 | 52.22977
Warsaw | N/A | Poland | 21.01178 | 52.22977
Wroclaw | N/A | Poland | 17.03333 | 51.1
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bucharest | N/A | Romania | 26.10626 | 44.43225
Cluj-Napoca | N/A | Romania | 23.6 | 46.76667
Constanța | N/A | Romania | 28.63432 | 44.18073
Oradea | N/A | Romania | 21.91833 | 47.0458
Saint Brasov | N/A | Romania | N/A | N/A
Târgu Mureş | N/A | Romania | 24.55747 | 46.54245
Timișoara | N/A | Romania | 21.22571 | 45.75372
Petrozavodsk | Republic of Karelia | Russia | 34.34691 | 61.78491
Arkhangelsk | N/A | Russia | 40.55291 | 64.54717
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Rostov-on-Don | N/A | Russia | 39.72328 | 47.23135
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saratov | N/A | Russia | 46.00861 | 51.54056
Tatarstan | N/A | Russia | 53.37033 | 56.12922
Yekaterinburg | N/A | Russia | 60.6122 | 56.8519
Yekaterinburg | N/A | Russia | 60.6122 | 56.8519
Belgrade | N/A | Serbia | 20.46513 | 44.80401
Knez-Selo | N/A | Serbia | 22.0006 | 43.36703
Kragujevac | N/A | Serbia | 20.91667 | 44.01667
Bratislava | N/A | Slovakia | 17.10674 | 48.14816
Nitra-Zobor | N/A | Slovakia | N/A | N/A
Bellville | Capetown | South Africa | 18.62847 | -33.90022
Benomi | N/A | South Africa | N/A | N/A
Cape Town | N/A | South Africa | 18.42322 | -33.92584
Cape Town | N/A | South Africa | 18.42322 | -33.92584
Krugersdorp | N/A | South Africa | 27.77515 | -26.08577
Port Elizabeth | N/A | South Africa | 25.61494 | -33.96109
Pretoria | N/A | South Africa | 28.18783 | -25.74486
Pretoria | N/A | South Africa | 28.18783 | -25.74486
Pretoria | N/A | South Africa | 28.18783 | -25.74486
Pretoria | N/A | South Africa | 28.18783 | -25.74486
Somerset West | N/A | South Africa | 18.82113 | -34.08401
Worcester | N/A | South Africa | 19.44852 | -33.64651
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Elche | N/A | Spain | -0.70107 | 38.26218
León | N/A | Spain | -5.57032 | 42.60003
Madrid | N/A | Spain | -3.70256 | 40.4165
Valencia | N/A | Spain | -0.37966 | 39.47391
Vizcaya | N/A | Spain | N/A | N/A
Biel | N/A | Switzerland | 8.21773 | 46.45587
Geneva | N/A | Switzerland | 6.14569 | 46.20222
La Chaux-de-Fonds | N/A | Switzerland | 6.82586 | 47.09993
Lugano | N/A | Switzerland | 8.96004 | 46.01008
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Bangkok | N/A | Thailand | 100.50144 | 13.75398
Chiang Mai | N/A | Thailand | 98.98468 | 18.79038
Khonkaen | N/A | Thailand | N/A | N/A
Nonthaburi | N/A | Thailand | 100.51477 | 13.86075
Aviv | N/A | Ukraine | N/A | N/A
Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664
Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664
Donetsk | N/A | Ukraine | 37.80224 | 48.023
Ivano-Frankivsk | N/A | Ukraine | 24.71248 | 48.92312
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Luhansk | N/A | Ukraine | 39.30553 | 48.56814
Odesa | N/A | Ukraine | 30.74383 | 46.48572
Poltava | N/A | Ukraine | 34.55367 | 49.58925
Uzhhorod | N/A | Ukraine | 22.2947 | 48.6242 | 606 | 0 | 0 | 0 | NCT00621504 | 1COMPLETED | 2009-06-01 | 2008-01-01 | Forest Laboratories | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 5 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine if dexamethasone given at night is a more effective treatment for congenital adrenal hyperplasia in young children than standard three times per day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone and one on nocturnal dexamethasone. | This is a Phase II clinical trial, intended to estimate the effect of instituting Dexamethasone therapy in comparison to prior standard therapy. Each subject provides his own baseline data. There is no control group. Patients with CAH who meet inclusion criteria will be admitted to the clinical research center for two 24 hour hospitalizations. Adrenal hormone profiles will be measured during each hospitalization. The patient will take his or her baseline hydrocortisone regimen during one hospitalization and a new regimen consisting of a single daily nocturnal dose of Dexamethasone during the second hospitalization. | Adrenal Hyperplasia, Congenital | null | 1 | arm 1: Experimental therapy with nocturnal dexamethasone. | [
0
] | 2 | [
0,
0
] | intervention 1: Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days. intervention 2: Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily for one subject. Doses were given at 8 AM, 2 PM, and 8 PM. The 2 PM time point was skipped for the subject who received hydrocortisone twice daily. Doses ranged from 6.9 to 18.5 milligrams per meter squared per day and were based on each individual's baseline regimen. | intervention 1: dexamethasone intervention 2: Hydrocortisone | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 10 | 0 | 0 | 0 | NCT00621985 | 1COMPLETED | 2009-06-01 | 2008-04-01 | Boston Children's Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 838 | null | null | 0TREATMENT | null | false | 0ALL | null | The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.
An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.
The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward). | null | Hypertension | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: fixed-dose combination of telmisartan 40mg+amlodipine 10mg intervention 2: fixed-dose combination of telmisartan 80mg+amlodipine10mg | 92 | Gosford | New South Wales | Australia | 151.34399 | -33.4244
Liverpool | New South Wales | Australia | 150.92588 | -33.91938
Kippa-Ring | Queensland | Australia | 153.0835 | -27.22586
Milton | Queensland | Australia | 153.00312 | -27.47039
Elizabeth Vale | South Australia | Australia | 138.66819 | -34.74857
Eggenburg | N/A | Austria | 15.81903 | 48.63892
Hainburg A.d. Donau | N/A | Austria | N/A | N/A
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Burgas | N/A | Bulgaria | 27.46781 | 42.50606
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Benátky nad Jizerou | N/A | Czechia | 14.82343 | 50.29085
Brno | N/A | Czechia | 16.60796 | 49.19522
Pilsen | N/A | Czechia | 13.37759 | 49.74747
Prague | N/A | Czechia | 14.42076 | 50.08804
Příbram | N/A | Czechia | 14.01043 | 49.68988
Slaný | N/A | Czechia | 14.08693 | 50.23046
Strakonice | N/A | Czechia | 13.90237 | 49.26141
Birr | N/A | Ireland | -7.91333 | 53.09139
Carrigtowhill | N/A | Ireland | N/A | N/A
Gorey, Co. Wexford | N/A | Ireland | -6.2925 | 52.67472
Mallow | N/A | Ireland | -8.63333 | 52.13333
New Ross | N/A | Ireland | -6.93667 | 52.39667
Broni (pv) | N/A | Italy | 9.25993 | 45.06394
Coppito (AQ) | N/A | Italy | 13.34358 | 42.3673
Ferrara | N/A | Italy | 11.62057 | 44.83804
Dunedin | N/A | New Zealand | 170.50361 | -45.87416
Otahuhu, Auckland | N/A | New Zealand | N/A | N/A
Tauranga | N/A | New Zealand | 176.16667 | -37.68611
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Dolný Kubín | N/A | Slovakia | 19.30341 | 49.20983
Kralovsky Chmlec | N/A | Slovakia | N/A | N/A
Liptovský Mikuláš | N/A | Slovakia | 19.62218 | 49.08061
Považská Bystrica | N/A | Slovakia | 18.42169 | 49.12153
Prešov | N/A | Slovakia | 21.23393 | 48.99839
Trenčín | N/A | Slovakia | 18.04436 | 48.89452
Vráble | N/A | Slovakia | 18.30846 | 48.24371
Badalona | N/A | Spain | 2.24741 | 41.45004
Badalona | N/A | Spain | 2.24741 | 41.45004
Barcelona | N/A | Spain | 2.15899 | 41.38879
Jerez de La Frontera (Cádiz) | N/A | Spain | -6.13606 | 36.68645
L'Hospitalet de Llobregat (Barcelona) | N/A | Spain | 2.10028 | 41.35967
Madrid | N/A | Spain | -3.70256 | 40.4165
Madrid | N/A | Spain | -3.70256 | 40.4165
Mataró | N/A | Spain | 2.4445 | 41.54211
Oviedo | N/A | Spain | -5.84476 | 43.36029
Santa Coloma de Gramanet | N/A | Spain | N/A | N/A
Santa Coloma de Gramanet | N/A | Spain | N/A | N/A
Dnipro | N/A | Ukraine | 35.04066 | 48.46664
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kiev | N/A | Ukraine | 30.5238 | 50.45466
Kiev | N/A | Ukraine | 30.5238 | 50.45466
Kiev | N/A | Ukraine | 30.5238 | 50.45466
Kiev | N/A | Ukraine | 30.5238 | 50.45466
Lviv | N/A | Ukraine | 24.02324 | 49.83826
Odesa | N/A | Ukraine | 30.74383 | 46.48572
Odesa | N/A | Ukraine | 30.74383 | 46.48572
Zaporizhzhya | N/A | Ukraine | 35.11714 | 47.85167
Bexhill-on-Sea | N/A | United Kingdom | 0.47095 | 50.85023
Blackpool | N/A | United Kingdom | -3.05 | 53.81667
Blackpool | N/A | United Kingdom | -3.05 | 53.81667
Burbage | N/A | United Kingdom | -1.67087 | 51.35184
Chestfield, Whitstable | N/A | United Kingdom | N/A | N/A
Chorley | N/A | United Kingdom | -2.61667 | 53.65
Edgbaston, Birmingham | N/A | United Kingdom | N/A | N/A
Ely | N/A | United Kingdom | 0.26196 | 52.39964
Fowey | N/A | United Kingdom | -4.6386 | 50.33634
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515
Penzance | N/A | United Kingdom | -5.53715 | 50.11861
Plymouth | N/A | United Kingdom | -4.14305 | 50.37153
Reading | N/A | United Kingdom | -0.97113 | 51.45625
St Austell | N/A | United Kingdom | -4.77442 | 50.3425
Whitstable | N/A | United Kingdom | 1.0257 | 51.3607 | 1,449 | 0 | 0 | 0 | NCT00624052 | 1COMPLETED | 2009-06-01 | 2008-03-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 773 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | An international, multi-centre, prospective three arm parallel-group, phase II proof of concept study comparing the efficacy and safety of two dosage regimens (BID 7 days and TID 7 days) of TD1414 2% cream and one dosage regimen (BID 7 days) of Bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or SITL. Furthermore an evaluation of the pharmacokinetics of TD1414 2% cream TID for 7 days will be performed. A total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group. | null | Impetigo Secondarily Infected Traumatic Lesions | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: BID 7 days intervention 2: TID 7 days intervention 3: BID 7 days | intervention 1: TD1414 2% cream intervention 2: TD1414 2% cream intervention 3: Bactroban® (mupirocin) 2% cream | 2 | Anniston | Alabama | United States | -85.83163 | 33.65983
Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 | 677 | 0 | 0 | 0 | NCT00626795 | 1COMPLETED | 2009-06-01 | 2008-02-01 | LEO Pharma | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 343 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain | null | Chronic Pain | OA Chronic Pain Osteoarthritis OA Pain Osteoarthritis Pain Pain Hip Pain Knee Pain Joint Pain | null | 2 | arm 1: OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg arm 2: Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase). | [
0,
2
] | 2 | [
0,
0
] | intervention 1: hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets intervention 2: Placebo | intervention 1: OROS hydromorphone intervention 2: Placebo | 0 | null | 538 | 0 | 0 | 0 | NCT00631319 | 1COMPLETED | 2009-06-01 | 2008-02-01 | Mallinckrodt | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 23 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This Phase 1 study of oral ixabepilone given every 6 hours for 3 doses on Day 1, every 21 days, was a dose-finding study designed to determine the maximum tolerated dose (MTD) and safety of this dosing schedule in participants with advanced cancer | null | Advanced Solid Tumors | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Capsules, Oral, Dose escalating (Phase 1), 3 doses on 1 day every 3 weeks, until disease progression or unacceptable toxicity | intervention 1: Ixabepilone (oral formulation) | 2 | Stanford | California | United States | -122.16608 | 37.42411
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 18 | 0 | 0 | 0 | NCT00632424 | 6TERMINATED | 2009-06-01 | 2008-05-01 | R-Pharm | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 93 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent allergic asthma. | This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate MDI formulation and medium dose mometasone furoate (MF) DPI and MDI formulations in adults and adolescents with persistent allergic asthma. An open-label run in period is to be followed by a double-blind treatment period.
A total of 90 subjects (15 per treatment) will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation, accounting for a 20% drop-out rate. A sample size of 12 subjects per treatment is required to detect a treatment difference of 28% in percent change of eNO at Day 14, assuming a pooled standard deviation of 20% with a power of 90%. These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by S.A. Kharitonov et. al, 2003.
Subjects will be randomized to one of six treatment groups (MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, MF DPI 200 mcg BID, MF MDI 200 mcg BID, or Placebo MDI BID) according to an Schering-Plough Research Institute (SPRI) computer-generated randomization schedule. Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software (SAS). | Asthma Airway Inflammation | mometasone formoterol | null | 6 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None | [
0,
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days intervention 2: mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days intervention 3: mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days intervention 4: MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days intervention 5: MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days intervention 6: MF/F MDI placebo twice daily (BID) (2 inhalations) | intervention 1: mometasone furoate/formoterol 100/10 mcg intervention 2: mometasone furoate/formoterol 200/10 mcg intervention 3: mometasone furoate/formoterol 400/10 mcg intervention 4: MF DPI 200 mcg intervention 5: MF MDI 200 mcg intervention 6: Placebo | 0 | null | 93 | 0 | 0 | 0 | NCT00635882 | 1COMPLETED | 2009-06-01 | 2008-02-01 | Organon and Co | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 389 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control. | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: BI 1356 5mg in initial combination therapy with pioglitazone 30 mg arm 2: Placebo in initial combination therapy with pioglitazone 30 mg | [
0,
2
] | 2 | [
0,
0
] | intervention 1: placebo + overcapsulated 30 mg tablet, once daily intervention 2: 5 mg tablet + overcapsulated 30 mg tablet, once daily | intervention 1: placebo + pioglitazone (30 mg) intervention 2: Linagliptin + pioglitazone (30 mg) | 43 | Feldkirch | N/A | Austria | 9.6 | 47.23306
Graz | N/A | Austria | 15.45 | 47.06667
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Athens | N/A | Greece | 23.72784 | 37.98376
Athens | N/A | Greece | 23.72784 | 37.98376
Ioannina | N/A | Greece | 20.85189 | 39.66486
Melissia-Athens | N/A | Greece | N/A | N/A
Nikaia | N/A | Greece | 23.65 | 37.96667
Thessaloniki | N/A | Greece | 22.93086 | 40.64361
Thessaloniki | N/A | Greece | 22.93086 | 40.64361
Thessaloniki | N/A | Greece | 22.93086 | 40.64361
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Debrecen | N/A | Hungary | 21.62444 | 47.53167
Győr | N/A | Hungary | 17.63512 | 47.68333
Szombathely | N/A | Hungary | 16.62155 | 47.23088
Amagasaki, Hyogo | N/A | Japan | N/A | N/A
Koganei, Tokyo | N/A | Japan | N/A | N/A
Osaka, Osaka | N/A | Japan | N/A | N/A
Shinjyuku-ku,Tokyo | N/A | Japan | 139.69171 | 35.6895
Suita, Osaka, | N/A | Japan | N/A | N/A
Aveiro | N/A | Portugal | -8.64554 | 40.64427
Lisbon | N/A | Portugal | -9.1498 | 38.72509
Alba Iulia | N/A | Romania | 23.58333 | 46.06667
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bucharest | N/A | Romania | 26.10626 | 44.43225
Sibiu | N/A | Romania | 24.15 | 45.8
Târgu Mureş | N/A | Romania | 24.55747 | 46.54245
Badalona | N/A | Spain | 2.24741 | 41.45004
Badia Del Vallés | N/A | Spain | N/A | N/A
Bercelona | N/A | Spain | N/A | N/A
Borges Del Camp | N/A | Spain | N/A | N/A
Centelles | N/A | Spain | 2.21902 | 41.79746
Granada | N/A | Spain | -3.60667 | 37.18817
L'Hospitalet de Llobregat (Barcelona) | N/A | Spain | 2.10028 | 41.35967
L'Hospitalet de Llobregat (Barcelona) | N/A | Spain | 2.10028 | 41.35967
Madrid | N/A | Spain | -3.70256 | 40.4165
Madrid | N/A | Spain | -3.70256 | 40.4165
Sant Adrià Del Besós (Barcelona) | N/A | Spain | N/A | N/A
Seville | N/A | Spain | -5.97317 | 37.38283
Vic (Barcelona) | N/A | Spain | 2.25486 | 41.93012 | 389 | 0 | 0 | 0 | NCT00641043 | 1COMPLETED | 2009-06-01 | 2008-03-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To investigate the potential to reduce concomitant antipsychotic medication use in subjects with moderate dementia of Alzheimer's type, treated with memantine. | null | Alzheimer's Disease | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: memantine tablets, twice a day (bid), for 20 weeks | intervention 1: Memantine | 1 | Krefeld | North Rhine-Westphalia | Germany | 6.55381 | 51.33645 | 19 | 0 | 0 | 0 | NCT00649220 | 6TERMINATED | 2009-06-01 | 2008-07-01 | Merz Pharmaceuticals GmbH | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 151 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. | null | Hypercholesterolemia | null | 1 | arm 1: Ezetimibe 10 mg + Simvastatin 20 mg | [
0
] | 2 | [
0,
0
] | intervention 1: Ezetimibe 10 mg once daily intervention 2: Simvastatin 20 mg daily | intervention 1: Ezetimibe intervention 2: Simvastatin | 0 | null | 151 | 0 | 0 | 0 | NCT00653523 | 1COMPLETED | 2009-06-01 | 2007-12-01 | Organon and Co | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 146 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors. | null | Hypercholesterolemia | null | 1 | arm 1: Ezetimibe 10 mg + Atorvastatin 20 mg | [
0
] | 2 | [
0,
0
] | intervention 1: Ezetimibe 10 mg once daily intervention 2: atorvastatin 20 mg once daily | intervention 1: Ezetimibe intervention 2: atorvastatin | 0 | null | 146 | 0 | 0 | 0 | NCT00654095 | 1COMPLETED | 2009-06-01 | 2007-12-01 | Organon and Co | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 306 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS) | null | Restless Legs Syndrome | null | 2 | arm 1: 4 weeks of individual dose titration starting with Pramipexole 0.125 mg, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily arm 2: 4 weeks of individual dose titration as for the investigational product, once daily | [
5,
5
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Pramipexole intervention 2: Placebo | 16 | Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Guangzhou | N/A | China | 113.25 | 23.11667
Haerbin | N/A | China | N/A | N/A
Hangzhou | N/A | China | 120.16142 | 30.29365
Nanjing | N/A | China | 118.77778 | 32.06167
Qingdao | N/A | China | 120.38042 | 36.06488
Shanghai | N/A | China | 121.45806 | 31.22222
Shanghai | N/A | China | 121.45806 | 31.22222
Shanghai | N/A | China | 121.45806 | 31.22222
Suzhou | N/A | China | 120.59538 | 31.30408
Wuhan | N/A | China | 114.26667 | 30.58333
Xian, Shanxi Province | N/A | China | 108.92861 | 34.25833 | 305 | 0 | 0 | 0 | NCT00654498 | 1COMPLETED | 2009-06-01 | 2008-04-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 207 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects. | This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met. | Type 2 Diabetes Hypertension | blood pressure reduction | null | 1 | arm 1: amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Amlodipine 5 mg tablets , Daily for 3 weeks; intervention 2: amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg intervention 3: hydrochlorothiazide tablets, 12.5 mg or 25 mg. | intervention 1: Amlodipine intervention 2: amlodipine / olmesartan medoxomil combination intervention 3: Hydrochlorothiazide | 21 | Los Angeles | California | United States | -118.24368 | 34.05223
Sylmar | California | United States | -118.44925 | 34.30778
Tustin | California | United States | -117.82617 | 33.74585
Aventura | Florida | United States | -80.13921 | 25.95648
DeLand | Florida | United States | -81.30312 | 29.02832
Hialeah | Florida | United States | -80.27811 | 25.8576
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Avon | Indiana | United States | -86.39972 | 39.76282
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Las Vegas | Nevada | United States | -115.13722 | 36.17497
New Windsor | New York | United States | -74.02375 | 41.47676
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Charleston | South Carolina | United States | -79.93275 | 32.77632
Greer | South Carolina | United States | -82.22706 | 34.93873
Taylors | South Carolina | United States | -82.29623 | 34.92039
Nashville | Tennessee | United States | -86.78444 | 36.16589
Dallas | Texas | United States | -96.80667 | 32.78306
San Antonio | Texas | United States | -98.49363 | 29.42412
Burke | Virginia | United States | -77.27165 | 38.79345 | 1,200 | 0 | 0 | 0 | NCT00654745 | 1COMPLETED | 2009-06-01 | 2008-05-01 | Daiichi Sankyo | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 167 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection | null | Chronic Hepatitis C | null | 6 | arm 1: Daclatasvir (1 mg), once daily
or
Matching Placebo, once daily arm 2: Daclatasvir (10 mg), once daily
or
Matching Placebo, once daily arm 3: Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily arm 4: Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily arm 5: Group 5: Active Comparator
Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily arm 6: Group 6: Active Comparator
Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily | [
1,
1,
1,
1,
1,
1
] | 2 | [
0,
0
] | intervention 1: Capsule, Oral, Approximately 182 days from initial dosing intervention 2: Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel | intervention 1: Daclatasvir intervention 2: Placebo | 8 | Anaheim | California | United States | -117.9145 | 33.83529
Cypress | California | United States | -118.03729 | 33.81696
New Haven | Connecticut | United States | -72.92816 | 41.30815
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
Baltimore | Maryland | United States | -76.61219 | 39.29038
San Antonio | Texas | United States | -98.49363 | 29.42412
Santurce | N/A | Puerto Rico | -67.14018 | 18.19523 | 30 | 0 | 0 | 0 | NCT00663208 | 1COMPLETED | 2009-06-01 | 2008-05-01 | Bristol-Myers Squibb | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 16 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 2MALE | false | We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism. | This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group. | Contraception Hypogonadism | Male Contraception Hypogonadism Testosterone | null | 2 | arm 1: (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. arm 2: (Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 300 mcg/kg intervention 2: 24 hours after acyline administration on Day 2 "immediate release" Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once. intervention 3: 1 mg PO once daily \[day -2 to day 12) 14 days total | intervention 1: Acyline intervention 2: Testosterone intervention 3: Finasteride | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 16 | 0 | 0 | 0 | NCT00663793 | 1COMPLETED | 2009-06-01 | 2008-10-01 | University of Washington | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 13 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing hemodialysis who are resistant to treatment with calcitriol. | This is a multi-center, prospective, open label, one arm, phase IV study designed to demonstrate paricalcitol efficacy and safety in the treatment of moderate to severe secondary hyperparathyroidism in calcitriol resistant participants on dialysis.
Following screening, participants began an 8-week controlled calcitriol therapy period. Participants whose parathyroid hormone (PTH) levels decreased were to be discontinued from the study. Those whose PTH levels did not decrease began paricalcitol therapy using a dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol was administered intravenously at anytime during the subjects' dialysis. The paricalcitol dose was to be titrated every 2 weeks until iPTH was reduced or up to 4 months, after which it was to be adjusted monthly for 1 year based on serum PTH, calcium, phosphorus, and albumin measurements. | Secondary Hyperparathyroidism Dialysis | Dialysis Calcitriol Resistant Secondary Hyperparathyroidism | null | 1 | arm 1: Participants began a controlled calcitriol therapy period (calcitriol challenge) to confirm calcitriol resistance. After this period, those who failed to reduce PTH (according to parameters in protocol) initiated paricalcitol therapy. | [
5
] | 2 | [
0,
0
] | intervention 1: Initial doses determined according to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guideline (Am J Kidney Dis 2003;42(4)Suppl 3:S1-S201). During therapy, calcitriol dose may be modified by 0.5 - 1 mcg at 2- to 4-week intervals. intervention 2: Dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol will be administered intravenously after the participants' dialysis. The paricalcitol dose will be titrated every 2 weeks until iPTH presents a reduction or up to 4 months, after which it will be adjusted monthly based on serum PTH, calcium, phosphorus and albumin measurements. Dosing may be modified by 2-4 mcg increments at 2- to 4-week intervals. | intervention 1: Calcitriol intervention 2: Paricalcitol | 2 | São Paulo | N/A | Brazil | -46.63611 | -23.5475
São Paulo | N/A | Brazil | -46.63611 | -23.5475 | 13 | 0 | 0 | 0 | NCT00664430 | 6TERMINATED | 2009-06-01 | 2009-01-01 | Abbott | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 219 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy. | null | Rheumatoid Arthritis | null | 2 | arm 1: Fostamatinib disodium (R935788) 100 mg tablet, orally, twice-a-day arm 2: Placebo, orally, twice-a-day | [
0,
2
] | 2 | [
0,
0
] | intervention 1: R935788 100 mg tablet, orally, twice-a-day intervention 2: Placebo, orally, twice-a-day | intervention 1: Fostamatinib disodium (R935788) intervention 2: Placebo | 44 | Aventura | California | United States | N/A | N/A
Palm Desert | California | United States | -116.37697 | 33.72255
San Diego | California | United States | -117.16472 | 32.71571
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Boca Raton | Florida | United States | -80.0831 | 26.35869
Gainsville | Florida | United States | N/A | N/A
Ocala | Florida | United States | -82.14009 | 29.1872
Sarasota | Florida | United States | -82.53065 | 27.33643
Boise | Idaho | United States | -116.20345 | 43.6135
Chicago | Illinois | United States | -87.65005 | 41.85003
South Bend | Indiana | United States | -86.25001 | 41.68338
Elizabethtown | Kentucky | United States | -85.85913 | 37.69395
Cumberland | Maryland | United States | -78.76252 | 39.65287
Hagerstown | Maryland | United States | -77.71999 | 39.64176
Lansing | Michigan | United States | -84.55553 | 42.73253
Omaha | Nebraska | United States | -95.94043 | 41.25626
Lake Success | New York | United States | -73.71763 | 40.77066
Roslyn | New York | United States | -73.65096 | 40.79982
Smithtown | New York | United States | -73.20067 | 40.85593
Mayfield Village | Ohio | United States | N/A | N/A
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Erie | Pennsylvania | United States | -80.08506 | 42.12922
West Reading | Pennsylvania | United States | -75.94743 | 40.3337
Willow Grove | Pennsylvania | United States | -75.11573 | 40.144
Austin | Texas | United States | -97.74306 | 30.26715
Houston | Texas | United States | -95.36327 | 29.76328
Spokane | Washington | United States | -117.42908 | 47.65966
Antwepen | N/A | Belgium | N/A | N/A
Ghent | N/A | Belgium | 3.71667 | 51.05
Liège | N/A | Belgium | 5.56749 | 50.63373
Medellín | Antioquia | Colombia | -75.57151 | 6.245
Barranquilla | Atlántico | Colombia | -74.78132 | 10.96854
Bogota | Cundinamarca | Colombia | N/A | N/A
Bogota | Cundinamarca | Colombia | N/A | N/A
Bogota | Cundinamarca | Colombia | N/A | N/A
Bordeaux | N/A | France | -0.5805 | 44.84044
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Hamburg | N/A | Germany | 9.99302 | 53.55073
Leipzig | N/A | Germany | 12.37129 | 51.33962
Leipzig | N/A | Germany | 12.37129 | 51.33962
Würzburg | N/A | Germany | 9.95121 | 49.79391
Siena | N/A | Italy | 11.33064 | 43.31822
Udine | N/A | Italy | 13.23715 | 46.0693
Lima | N/A | Peru | -77.02824 | -12.04318 | 219 | 0 | 0 | 0 | NCT00665626 | 1COMPLETED | 2009-06-01 | 2008-05-01 | Rigel Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 457 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate. | null | Rheumatoid Arthritis | null | 3 | arm 1: R788, 100 mg tablet, orally, twice-a-day arm 2: R788, 150 mg tablet, orally, once a day arm 3: Placebo, orally, either once a day, or twice a day | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 100 mg tablet, orally, twice-a-day intervention 2: 150 mg tablet, orally, once a day intervention 3: Placebo, orally, either once a day, or twice a day | intervention 1: Fostamatinib disodium (R935788) intervention 2: Fostamatinib disodium (R935788) intervention 3: Placebo | 65 | La Jolla | California | United States | -117.2742 | 32.84727
Palm Desert | California | United States | -116.37697 | 33.72255
Hamden | Connecticut | United States | -72.89677 | 41.39593
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Gainsville | Florida | United States | N/A | N/A
Ocala | Florida | United States | -82.14009 | 29.1872
Orlando | Florida | United States | -81.37924 | 28.53834
Sarasota | Florida | United States | -82.53065 | 27.33643
Chicago | Illinois | United States | -87.65005 | 41.85003
South Bend | Indiana | United States | -86.25001 | 41.68338
Elizabethtown | Kentucky | United States | -85.85913 | 37.69395
Hagerstown | Maryland | United States | -77.71999 | 39.64176
Lansing | Michigan | United States | -84.55553 | 42.73253
Omaha | Nebraska | United States | -95.94043 | 41.25626
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Erie | Pennsylvania | United States | -80.08506 | 42.12922
West Reading | Pennsylvania | United States | -75.94743 | 40.3337
Willow Grove | Pennsylvania | United States | -75.11573 | 40.144
Charleston | South Carolina | United States | -79.93275 | 32.77632
Austin | Texas | United States | -97.74306 | 30.26715
San Antonio | Texas | United States | -98.49363 | 29.42412
Spokane | Washington | United States | -117.42908 | 47.65966
Sofia | Gsof | Bulgaria | 23.32415 | 42.69751
Plovdiv | PLO | Bulgaria | 24.75 | 42.15
Rousse | N/A | Bulgaria | 25.9534 | 43.84872
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Medellín | Antioquia | Colombia | -75.57151 | 6.245
Barranquilla | Atlántico | Colombia | -74.78132 | 10.96854
Barranquilla | Atlántico | Colombia | -74.78132 | 10.96854
Bogota | Cundinamarca | Colombia | N/A | N/A
Bogota | Cundinamarca | Colombia | N/A | N/A
Bogota | Cundinamarca | Colombia | N/A | N/A
Bogotá | Cundinamarca | Colombia | N/A | N/A
Bucaramanga | Santander Department | Colombia | -73.11895 | 7.125
Bucaramanga | Santander Department | Colombia | -73.11895 | 7.125
Chihuahua City | Chihuahua | Mexico | -106.08889 | 28.63528
Mexico | D.f. | Mexico | -98.43784 | 18.88011
Mexico | D.f. | Mexico | -98.43784 | 18.88011
Mexico | D.f. | Mexico | -98.43784 | 18.88011
Mexico | D.f. | Mexico | -98.43784 | 18.88011
León | Guanajuato | Mexico | -101.67374 | 21.12908
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
Morelia | Michoacán | Mexico | -101.18443 | 19.70078
Cuernavaca | Morelos | Mexico | -99.23075 | 18.9261
Bialystok | N/A | Poland | 23.16433 | 53.13333
Bytom | N/A | Poland | 18.93282 | 50.34802
Elblag | N/A | Poland | 19.40884 | 54.1522
Grodzisk Mazowiecki | N/A | Poland | 20.6337 | 52.10387
Krakow | N/A | Poland | 19.93658 | 50.06143
Krakow | N/A | Poland | 19.93658 | 50.06143
Lublin | N/A | Poland | 22.56667 | 51.25
Torun | N/A | Poland | 18.59814 | 53.01375
Wroclaw | N/A | Poland | 17.03333 | 51.1
Wroclaw | N/A | Poland | 17.03333 | 51.1
Zyradow | N/A | Poland | N/A | N/A
Cluj-Napoca | Cluj | Romania | 23.6 | 46.76667
Bucharest | Sector 1 | Romania | 26.10626 | 44.43225
Sibiu | Sibiu County | Romania | 24.15 | 45.8
Brăila | N/A | Romania | 27.97429 | 45.27152
Bucharest | N/A | Romania | 26.10626 | 44.43225
Sf. Gheorghe | N/A | Romania | N/A | N/A | 457 | 0 | 0 | 0 | NCT00665925 | 1COMPLETED | 2009-06-01 | 2008-05-01 | Rigel Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 29 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children. | null | Molluscum Contagiosum, Skin Disease | null | 2 | arm 1: Subjects in this group will have topical application of cantharidin's vehicle at each visit. arm 2: Subjects in this group will have topical application of cantharidin at each visit. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits. intervention 2: Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events. | intervention 1: cantharidin's vehicle intervention 2: Cantharidin 0.7% | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 29 | 0 | 0 | 0 | NCT00667225 | 1COMPLETED | 2009-06-01 | 2008-01-01 | University of North Carolina, Chapel Hill | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2,
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness. | null | Asthma | Asthma hyperresponsiveness | null | 1 | arm 1: Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated. | [
0
] | 1 | [
0
] | intervention 1: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in. | intervention 1: nadolol | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 10 | 0 | 0 | 0 | NCT00670267 | 1COMPLETED | 2009-06-01 | 2007-01-01 | Invion, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 151 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms. | This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.
Study with completed results acquired from Horizon in 2024. | Cystic Fibrosis (CF) | null | 4 | arm 1: Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days arm 2: MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days arm 3: MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days arm 4: MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days | [
2,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: 3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days intervention 2: same frequency as study drug using the same nebulizer | intervention 1: MP-376 intervention 2: Placebo | 50 | Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Oakland | California | United States | -122.2708 | 37.80437
Orange | California | United States | -117.85311 | 33.78779
Palo Alto | California | United States | -122.14302 | 37.44188
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
Chicago | Illinois | United States | -87.65005 | 41.85003
Oak Lawn | Illinois | United States | -87.75811 | 41.71087
Park Ridge | Illinois | United States | -87.84062 | 42.01114
Iowa City | Iowa | United States | -91.53017 | 41.66113
Louisville | Kentucky | United States | -85.75941 | 38.25424
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Kalamazoo | Michigan | United States | -85.58723 | 42.29171
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Morristown | New Jersey | United States | -74.48154 | 40.79677
Albany | New York | United States | -73.75623 | 42.65258
Valhalla | New York | United States | -73.77513 | 41.07482
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Columbus | Ohio | United States | -82.99879 | 39.96118
Dayton | Ohio | United States | -84.19161 | 39.75895
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Charleston | South Carolina | United States | -79.93275 | 32.77632
Columbia | South Carolina | United States | -81.03481 | 34.00071
Memphis | Tennessee | United States | -90.04898 | 35.14953
San Antonio | Texas | United States | -98.49363 | 29.42412
Tyler | Texas | United States | -95.30106 | 32.35126
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Berlin | N/A | Germany | 13.41053 | 52.52437
Essen | N/A | Germany | 7.01228 | 51.45657
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Gerlingen | N/A | Germany | 9.06316 | 48.79954
Gieben | N/A | Germany | N/A | N/A
Kiel | N/A | Germany | 10.13489 | 54.32133
München | N/A | Germany | 13.31243 | 51.60698
Tübingen | N/A | Germany | 9.05222 | 48.52266
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Groesbeek | N/A | Netherlands | 5.93611 | 51.77667
Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 | 151 | 0 | 0 | 0 | NCT00677365 | 1COMPLETED | 2009-06-01 | 2008-06-01 | Amgen | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator. | null | Carcinoma, Renal Cell | Renal Cell Cancer Interferon | null | 2 | arm 1: Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. arm 2: Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously intervention 2: Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. | intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Sorafenib (Nexavar, BAY43-9006) + Interferon | 35 | Vienna | Vienna | Austria | 16.37208 | 48.20849
Salzburg | N/A | Austria | 13.04399 | 47.79941
Avignon | N/A | France | 4.80892 | 43.94834
Bayonne | N/A | France | -1.473 | 43.49316
Bordeaux | N/A | France | -0.5805 | 44.84044
Marseille | N/A | France | 5.38107 | 43.29695
Marseille | N/A | France | 5.38107 | 43.29695
Nantes | N/A | France | -1.55336 | 47.21725
Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341
Reims | N/A | France | 4.02853 | 49.26526
Strasbourg | N/A | France | 7.74553 | 48.58392
Toulouse | N/A | France | 1.44367 | 43.60426
Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115
Dublin | Dublin | Ireland | -6.24889 | 53.33306
Cork | N/A | Ireland | -8.47061 | 51.89797
Aviano | Pordenone | Italy | 12.59472 | 46.07056
Legnago | Verona | Italy | 11.30227 | 45.19365
Napoli | N/A | Italy | 14.5195 | 40.87618
Pavia | N/A | Italy | 9.15917 | 45.19205
Perugia | N/A | Italy | 12.38878 | 43.1122
Reggio Emilia | N/A | Italy | 10.63125 | 44.69825
Gdansk | N/A | Poland | 18.64912 | 54.35227
Lublin | N/A | Poland | 22.56667 | 51.25
Warsaw | N/A | Poland | 21.01178 | 52.22977
Wroclaw | N/A | Poland | 17.03333 | 51.1
Barcelona | Barcelona | Spain | 2.15899 | 41.38879
Madrid | Madrid | Spain | -3.70256 | 40.4165
Madrid | Madrid | Spain | -3.70256 | 40.4165
Oviedo | Oviedo | Spain | -5.84476 | 43.36029
Pamplona | Pamplona | Spain | -1.64323 | 42.81687
Valencia | Valencia | Spain | -0.37966 | 39.47391
London | London | United Kingdom | -0.12574 | 51.50853
Northwood | Middlesex | United Kingdom | -0.42454 | 51.61162
Newcastle upon Tyne | Tyne and Wear | United Kingdom | -1.61396 | 54.97328 | 16 | 0 | 0 | 0 | NCT00678288 | 6TERMINATED | 2009-06-01 | 2008-04-01 | Bayer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Safety and Efficacy Study of TG-873870 (Nemonoxacin) in Diabetic Foot Infections | This study will assess the safety and efficacy of TG-873870 (Nemonoxacin) in patients with Diabetic Foot Infections. Pharmacokinetic (PK) and pharmacodynamic (PD) assessment will be conducted in a subgroup of eight consenting patients. | Diabetic Foot Infections | Diabetic Foot Infections, DFI, Nemonoxacin | null | 1 | arm 1: Nemonoxacin 750 mg,oral administration, single-arm, once daily 7±1 and 14±1 days. | [
5
] | 1 | [
0
] | intervention 1: 750 mg | intervention 1: TG-873870 (Nemonoxacin) | 16 | Montebello | California | United States | -118.10535 | 34.00946
Pasadena | California | United States | -118.14452 | 34.14778
Des Moines | Iowa | United States | -93.60911 | 41.60054
East Lynne | Gauteng | South Africa | 28.27777 | -25.70664
Hammanskraal | Gauteng | South Africa | N/A | N/A
Pretoria | Gauteng | South Africa | 28.18783 | -25.74486
Witbank | Gauteng | South Africa | N/A | N/A
Korsten | Port Elizabeth | South Africa | 25.57755 | -33.92228
Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Tainan City | N/A | Taiwan | 120.21333 | 22.99083
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896
Khon Kaen | N/A | Thailand | 102.833 | 16.44671 | 38 | 0 | 0 | 0 | NCT00685698 | 1COMPLETED | 2009-06-01 | 2008-06-01 | TaiGen Biotechnology Co., Ltd. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid cannabis abuse. | In the past adolescents with cannabis abuse have been excluded from studies in which atomoxetine for ADHD symptoms was studied. In this study the efficacy of atomoxetine on symptoms of ADHD in adolescents with ADHD and comorbid cannabis abuse will be studied. | Attention Deficit Hyperactivity Disorder Cannabis Abuse | Attention Deficit Hyperactivity Disorder with Cannabis Abuse Marihuana Abuse Comorbid Cannabis Abuse | null | 1 | arm 1: 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules. | [
0
] | 1 | [
0
] | intervention 1: 0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules. | intervention 1: Atomoxetine | 1 | The Hague | N/A | Netherlands | 4.29861 | 52.07667 | 7 | 0 | 0 | 0 | NCT00687609 | 6TERMINATED | 2009-06-01 | 2008-09-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 261 | NA | SINGLE_GROUP | 9OTHER | 0NONE | false | 1FEMALE | false | This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole | This is a multi-center prospective non-randomized single arm, open label trial in postmenopausal HR positive early breast cancer patients who experience grade 2-3 arthralgia-myalgia while on anastrozole, resulting in the discontinuation of anastrozole. After a 2-3 week period without any aromatase inhibitor treatment, eligible patients will initiate letrozole treatment at a dose of 2.5mg per day for a duration of 24 weeks. If a patient has breast cancer recurrence or is intolerant to letrozole during the 24 week period, the drug will be discontinued. | Breast Cancer | breast cancer adjuvant treatment in post menopausal women letrozole arthralgia-myalgia | null | 1 | arm 1: Participants received 2.5 milligram (mg) of Letrozole tablets orally once daily (QD) for a period of 24 weeks. | [
0
] | 1 | [
0
] | intervention 1: 2.5 mg daily by mouth for 6 months | intervention 1: letrozole | 48 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Grass Valley | California | United States | -121.06106 | 39.21906
Palm Springs | California | United States | -116.54529 | 33.8303
Pleasant Hill | California | United States | -122.0608 | 37.94798
Fort Collins | Colorado | United States | -105.08442 | 40.58526
Boca Raton | Florida | United States | -80.0831 | 26.35869
Fort Myers | Florida | United States | -81.84059 | 26.62168
Hollywood | Florida | United States | -80.14949 | 26.0112
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Athens | Georgia | United States | -83.37794 | 33.96095
Augusta | Georgia | United States | -81.97484 | 33.47097
Gainesville | Georgia | United States | -83.82407 | 34.29788
Elk Grove Village | Illinois | United States | -87.97035 | 42.00392
Evanston | Illinois | United States | -87.69006 | 42.04114
Skokie | Illinois | United States | -87.73339 | 42.03336
Wichita | Kansas | United States | -97.33754 | 37.69224
Louisville | Kentucky | United States | -85.75941 | 38.25424
Portland | Maine | United States | -70.2589 | 43.65737
Baltimore | Maryland | United States | -76.61219 | 39.29038
Baltimore | Maryland | United States | -76.61219 | 39.29038
Bethesda | Maryland | United States | -77.10026 | 38.98067
Lambertville | Michigan | United States | -83.62799 | 41.76588
St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727
Lincoln | Nebraska | United States | -96.66696 | 40.8
Elizabeth | New Jersey | United States | -74.2107 | 40.66399
Morristown | New Jersey | United States | -74.48154 | 40.79677
Somerville | New Jersey | United States | -74.60988 | 40.57427
Voorhees Township | New Jersey | United States | -74.49062 | 40.4795
Binghamton | New York | United States | -75.91797 | 42.09869
Asheville | North Carolina | United States | -82.55402 | 35.60095
Washington | North Carolina | United States | -77.05217 | 35.54655
Akron | Ohio | United States | -81.51901 | 41.08144
Medina | Ohio | United States | -81.86375 | 41.13839
West Reading | Pennsylvania | United States | -75.94743 | 40.3337
Columbia | South Carolina | United States | -81.03481 | 34.00071
Memphis | Tennessee | United States | -90.04898 | 35.14953
Nashville | Tennessee | United States | -86.78444 | 36.16589
Corpus Christi | Texas | United States | -97.39638 | 27.80058
Dallas | Texas | United States | -96.80667 | 32.78306
American Fork | Utah | United States | -111.79576 | 40.3769
Ogden | Utah | United States | -111.97383 | 41.223
Fairfax | Virginia | United States | -77.30637 | 38.84622
Harrisonburg | Virginia | United States | -78.86892 | 38.44957
Newport News | Virginia | United States | -76.42975 | 36.98038
Green Bay | Wisconsin | United States | -88.01983 | 44.51916
Wauwatosa | Wisconsin | United States | -88.00759 | 43.04946 | 261 | 0 | 0 | 0 | NCT00688909 | 1COMPLETED | 2009-06-01 | 2008-03-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 384 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension | null | Hypertension | Systolic blood pressure Diastolic blood pressure Valsartan Hydrochlorothiazide | null | 3 | arm 1: (patients initiated on valsartan) arm 2: (patients initiated on HCTZ) arm 3: (patients initiated on Valsartan+HCTZ) | [
1,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12. intervention 2: At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. intervention 3: At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal \<140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12. | intervention 1: Valsartan + HCTZ intervention 2: Valsartan intervention 3: HCTZ | 20 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Escondido | California | United States | -117.08642 | 33.11921
Fresno | California | United States | -119.77237 | 36.74773
Huntington Park | California | United States | -118.22507 | 33.98168
Pismo Beach | California | United States | -120.64128 | 35.14275
Miami | Florida | United States | -80.19366 | 25.77427
Ormond Beach | Florida | United States | -81.05589 | 29.28581
Conyers | Georgia | United States | -84.01769 | 33.66761
Lexington | Kentucky | United States | -84.47772 | 37.98869
Portland | Maine | United States | -70.2589 | 43.65737
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Buffalo | New York | United States | -78.87837 | 42.88645
Shelby | North Carolina | United States | -81.53565 | 35.29235
Carlisle | Ohio | United States | -84.32022 | 39.582
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Erie | Pennsylvania | United States | -80.08506 | 42.12922
Greer | South Carolina | United States | -82.22706 | 34.93873
Taylors | South Carolina | United States | -82.29623 | 34.92039
St. George | Utah | United States | -113.58412 | 37.10415 | 384 | 0 | 0 | 0 | NCT00698646 | 1COMPLETED | 2009-06-01 | 2008-04-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 400 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery. | null | Ocular Inflammation | null | 2 | arm 1: Loteprednol Etabonate 0.5% arm 2: Vehicle of Ophthalmic Loteprednol Etabonate | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days. intervention 2: Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days. | intervention 1: Loteprednol Etabonate intervention 2: Vehicle of Ophthalmic Loteprednol Etabonate | 1 | High Point | North Carolina | United States | -80.00532 | 35.95569 | 405 | 0 | 0 | 0 | NCT00699153 | 1COMPLETED | 2009-06-01 | 2008-06-01 | Bausch & Lomb Incorporated | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH). | Intracerebral hemorrhage (ICH) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. No medical or surgical interventions have been found to alter the natural evolution of this disease. The high risk for mortality and poor outcomes seems to occur despite relatively small hematoma volumes and small amounts of neuronal tissue at risk for injury. The reasons for this observation remain unknown; however perihematomal edema formation and inflammation that follows ICH seems to play an important role.
The Simvastatin for Intracerebral Hemorrhage Study is a prospective double blinded placebo controlled randomized (1:1) clinical trial that compares outcomes in patients receiving generic simvastatin 80 mg for 14 days or until death or discharge with patients in the placebo group.
The hypothesis for our study is that statins ameliorate perihematomal edema evolution thereby reducing mortality and improving functional outcomes following Intracerebral Hemorrhage (ICH). This hypothesis in turn is based on animal data showing suppression of inflammatory reaction and improved neurological outcomes following administration of statins to rodents with experimental ICH, and on a retrospective review of patients admitted to The Johns Hopkins Hospital over the last 7 years with spontaneous ICH which showed significantly better outcomes (decreased 30 day mortality secondary to decreased perihematomal edema) in patients on statins at the time of admission. | Intracerebral Hemorrhage | Intracerebral Hemorrhage Edema Statins | null | 2 | arm 1: Simvastatin Group arm 2: Placebo Group | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge. intervention 2: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge. | intervention 1: Simvastatin 80 mg intervention 2: Placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 1 | 0 | 0 | 0 | NCT00718328 | 6TERMINATED | 2009-06-01 | 2008-10-01 | Johns Hopkins University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 115 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia. | null | Postoperative Nausea and Vomiting | PONV nausea emesis antiemetics aprepitant ondansetron dexamethasone | null | 2 | arm 1: Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia arm 2: Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Aprepitant 40 mg + Dexamethasone 10 mg intervention 2: Ondansetron 4 mg + Dexamethasone 10 mg | intervention 1: Aprepitant + Dexamethasone intervention 2: Ondansetron + Dexamethasone | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 104 | 0 | 0 | 0 | NCT00734929 | 1COMPLETED | 2009-06-01 | 2007-09-01 | Duke University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 101 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug. | null | Diabetes | Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control | null | 2 | arm 1: Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) arm 2: Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067) | [
0,
0
] | 1 | [
0
] | intervention 1: Phentermine 15 mg/Topiramate controlled release (CR) 92 mg, oral capsule, once daily, 58 weeks | intervention 1: VI-0521 | 9 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Spring Valley | California | United States | -116.99892 | 32.74477
Walnut Creek | California | United States | -122.06496 | 37.90631
Bethesda | Maryland | United States | -77.10026 | 38.98067
Austin | Texas | United States | -97.74306 | 30.26715
San Antonio | Texas | United States | -98.49363 | 29.42412
Richmond | Virginia | United States | -77.46026 | 37.55376 | 101 | 0 | 0 | 0 | NCT00737633 | 6TERMINATED | 2009-06-01 | 2008-08-01 | VIVUS LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 76 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's Global Assessment (PGA - H\&F) greater-than or equal to 3 in subjects not suitable for other systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A (PUVA). | null | Chronic Plaque Psoriasis | Efalizumab, Chronic plaque psoriasis moderate to severe involving hands feet | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment. intervention 2: Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase) | intervention 1: Efalizumab - anti CD11a recombinant human monoclonal antibody intervention 2: Placebo | 1 | Vienna | N/A | Austria | 16.37208 | 48.20849 | 107 | 0 | 0 | 0 | NCT00739882 | 6TERMINATED | 2009-06-01 | 2008-04-01 | Merck KGaA, Darmstadt, Germany | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 16 | NON_RANDOMIZED | PARALLEL | null | 0NONE | true | 1FEMALE | false | This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function. | 16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the control group will consist of 8 healthy female adult volunteers. During Stage I, all subjects will receive a single oral dose of 25mg of Proellex® (fasting state) and be followed in a Clinical Research Unit (CRU) for about three days. Only subjects who do not experience serious adverse events (SAEs) or adverse events (AEs) that are determined by Investigator to be possibly, probably or definitely related to the treatment will participate in Stage II. The dose will be increased to a single dose of 50mg of Proellex® (fasting state) and subjects will be followed in a Clinical Research Unit (CRU) for about three days. Subjects will undergo blood draws at several time points. | Impaired Liver Function | null | 2 | arm 1: Proellex 25 mg in healthy females arm 2: Proellex 50 mg in hepatically impaired females | [
0,
0
] | 1 | [
0
] | intervention 1: Proellex 25 mg capsule, single dose | intervention 1: Proellex | 2 | Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834 | 16 | 0 | 0 | 0 | NCT00741273 | 1COMPLETED | 2009-06-01 | 2008-10-01 | Repros Therapeutics Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 15 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL | In this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. After the baseline period, patients will enter a treatment period of 6 days where a fixed dose of BSSL will be administered. The primary efficacy measurements will be made by collecting stool during the last three days of each period. | Cystic Fibrosis Exocrine Pancreatic Insufficiency | cystic fibrosis pancreatic insufficiency bucelipase alfa bile salt stimulating lipase BSSL coefficient of fat absorption | null | 1 | arm 1: 170 mg rhBSSL three times daily for 5 to 6 consecutive days | [
0
] | 1 | [
0
] | intervention 1: oral suspension, 170 mg BSSL, 3 times daily for 5-6 days | intervention 1: rhBSSL | 4 | Rotterdam | N/A | Netherlands | 4.47917 | 51.9225
Gdansk | N/A | Poland | 18.64912 | 54.35227
Poznan | N/A | Poland | 16.92993 | 52.40692
Rabka-Zdrój | N/A | Poland | 19.96654 | 49.60889 | 14 | 0 | 0 | 0 | NCT00743483 | 1COMPLETED | 2009-06-01 | 2008-08-01 | Swedish Orphan Biovitrum | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 140 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9, after reversal of a target depth of neuromuscular blockade (NMB) of 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 Sugammadex compared to Placebo, to evaluate the safety of 4.0 mg.kg-1 Sugammadex and to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay for these participants. | null | Anesthesia Neuromuscular Blockade | null | 2 | arm 1: Participants receiving 4.0 mg.kg-1 Sugammadex at a target depth of NMB of 1-2 PTC after the last dose of rocuronium arm 2: Participants receiving Placebo (0.9% NaCl) at a target depth of NMB of 1-2 PTC after the last dose of rocuronium | [
0,
2
] | 2 | [
0,
0
] | intervention 1: At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of 4.0 mg.kg-1 sugammadex (volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion. intervention 2: At a target depth of NMB of 1-2 PTC after the last dose of rocuronium, a bolus dose of placebo (0.9% NaCl, volume based on the actual body weight of the participant) will be administered, within 10 seconds into a fast running venous infusion. | intervention 1: Sugammadex intervention 2: 0.9% sodium chloride (NaCl) | 0 | null | 137 | 0 | 0 | 0 | NCT00758485 | 1COMPLETED | 2009-06-01 | 2008-10-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 52 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease | null | Chronic Obstructive Pulmonary Disease | COPD Moderate to severe COPD | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Oral tablet, twice daily, 4 weeks treatment intervention 2: Placebo | intervention 1: AZD1981 intervention 2: Placebo | 8 | Frieburg | N/A | Germany | N/A | N/A
Großhansdorf | N/A | Germany | 10.28333 | 53.66667
Hanover | N/A | Germany | 9.73322 | 52.37052
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Leicester | N/A | United Kingdom | -1.13169 | 52.6386
London | N/A | United Kingdom | -0.12574 | 51.50853
Manchester | N/A | United Kingdom | -2.23743 | 53.48095
Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328 | 51 | 0 | 0 | 0 | NCT00766415 | 1COMPLETED | 2009-06-01 | 2008-11-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 144 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis. | null | Allergic Conjunctivitis | null | 4 | arm 1: KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution arm 2: Naphazoline HCl 0.05% ophthalmic solution arm 3: Ketotifen fumarate 0.025% ophthalmic solution arm 4: Vehicle of KetoNaph ophthalmic solution | [
0,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4. intervention 2: One drop of Ketotifen in study eye at visit 3 and visit 4. intervention 3: One drop of naphazoline in study eye at vist 3 and visit 4. intervention 4: One drop of vehicle in study eye at visit 3 and visit 4. | intervention 1: Ketotifen/naphazoline intervention 2: Ketotifen intervention 3: Naphazoline intervention 4: Vehicle | 1 | North Andover | Massachusetts | United States | -71.13506 | 42.6987 | 144 | 0 | 0 | 0 | NCT00769886 | 1COMPLETED | 2009-06-01 | 2008-10-01 | Bausch & Lomb Incorporated | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 276 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study objective was to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown lines to be randomized in a 2:1 ratio to receive one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120. | The study was a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter phase 3 clinical trial. Approximately 285 females and males with moderate to severe glabellar frown lines at maximum frown were to be screened during a screening period of four months in order to randomize approximately 255 subjects into one treatment and one placebo group at a ratio of 2 : 1. After the single injection treatment with a total dose of 20 Units IncobotulinumtoxinA (Xeomin) or corresponding placebo, the subjects were observed over 120 days. During the study participation the subjects performed seven visits.
Eight (8) sites in the United States and Canada participated in this trial. The study was led by one Lead PI and a Co-Lead PI who was assisting the Lead PI. The role of the Lead PI and the Co-Lead PI was executed by one of the PIs of this study, respectively. The PI at each site was a medical doctor who was experienced in aesthetic dermatology, i.e. who had several years (\>=2 years) of experience in treatment of glabellar frown lines with BTX-A preparations. The PI was the person who led the team at one trial site and who was responsible for the conduct of the clinical trial at the site. The sub-investigator was a member of the team designated by the PI to perform important trial-related decisions. A maximum number of two sub-investigators could be authorized for injection and rating if necessary. At each site, ideally one investigator was to inject and rate all subjects. Injecting and rating sub-investigators had to be medical doctors with several years of experience in treatment of glabellar frown lines with BTX-A preparations. A subject had to be rated by the same investigator at all visits. Another phase 3 trial MRZ 60201-0741/1 (NCT00770211) with design and endpoints identical to those in this trial was performed in order to compare efficacy and safety results with a second study population. | Moderate to Severe Glabellar Frown Lines | null | 2 | arm 1: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection arm 2: Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection | [
0,
2
] | 2 | [
0,
0
] | intervention 1: The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL. intervention 2: The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin). | intervention 1: IncobotulinumtoxinA (Xeomin) (20 Units) intervention 2: Placebo | 8 | Los Angeles | California | United States | -118.24368 | 34.05223
Meatrie | Louisiana | United States | N/A | N/A
Chestnut Hill | Massachusetts | United States | -71.16616 | 42.33065
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Nashville | Tennessee | United States | -86.78444 | 36.16589
Vancouver | British Columbia | Canada | -123.11934 | 49.24966
Vancouver | British Columbia | Canada | -123.11934 | 49.24966
Toronto | Ontario | Canada | -79.39864 | 43.70643 | 276 | 0 | 0 | 0 | NCT00770029 | 1COMPLETED | 2009-06-01 | 2008-10-01 | Merz Pharmaceuticals GmbH | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 271 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown lines will be randomized in a 2:1 ratio to receive one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120. | The study was a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter phase 3 clinical trial. Approximately 285 females and males with moderate to severe glabellar frown lines at maximum frown were to be screened during a screening period of four months in order to randomize approximately 255 subjects into one treatment and one placebo group at a ratio of 2 : 1. After the single injection treatment with a total dose of 20 Units IncobotulinumtoxinA (Xeomin) or corresponding placebo, the subjects were observed over 120 days. During the study participation the subjects performed seven visits.
Eight (8) sites in the United States participated in this trial. The study was led by one Lead PI and a Co-Lead PI who was assisting the Lead PI. The role of the Lead PI and the Co-Lead PI was executed by one of the PIs of this study, respectively. The PI at each site was a medical doctor who was experienced in aesthetic dermatology, i.e. who had several years (\>= 2 years) of experience in treatment of glabellar frown lines with BTX-A preparations. The PI was the person who led the team at one trial site and who was responsible for the conduct of the clinical trial at the site. The sub-investigator was a member of the team designated by the PI to perform important trial-related decisions. A maximum number of two sub-investigators could be authorized for injection and rating if necessary. At each site, ideally one investigator was to inject and rate all subjects. Injecting and rating sub-investigators had to be medical doctors with several years of experience in treatment of glabellar frown lines with BTX-A preparations. A subject had to be rated by the same investigator at all visits. Another phase 3 trial MRZ 60201-0724/1 (NCT00770029) with design and endpoints identical to those in this trial was performed in order to compare efficacy and safety results with a second study population. | Moderate to Severe Glabellar Frown Lines | null | 2 | arm 1: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection arm 2: Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection | [
0,
2
] | 2 | [
0,
0
] | intervention 1: The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL. intervention 2: The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin). | intervention 1: IncobotulinumtoxinA (Xeomin) (20 Units) intervention 2: Placebo | 8 | Englewood | Colorado | United States | -104.98776 | 39.64777
Aventura | Florida | United States | -80.13921 | 25.95648
Coral Gables | Florida | United States | -80.26838 | 25.72149
Lincolnshire | Illinois | United States | -87.9084 | 42.19002
Carmel | Indiana | United States | -86.11804 | 39.97837
Omaha | Nebraska | United States | -95.94043 | 41.25626
Montclair | New Jersey | United States | -74.20903 | 40.82593
White Plains | New York | United States | -73.76291 | 41.03399 | 271 | 0 | 0 | 0 | NCT00770211 | 1COMPLETED | 2009-06-01 | 2008-10-01 | Merz Pharmaceuticals GmbH | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 37 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | false | PAI-1 is elevated in obese individuals. TNF-alpha, an inflammatory mediator is believed to play a role in obesity mediated elevations in PAI-1 levels. TNF-alpha blockade with antibodies and the drug pentoxifylline have been shown to lower PAI-1 levels in animal models. This study tests the hypothesis that pentoxifylline will lower PAI-1 levels in human subjects. | Obese individuals with elevated PAI-1 levels (greater than 10 ng/ml) are randomized to pentoxifylline 400mg, three times a day (TID) or placebo for 8 weeks. PAI-1, TNF-a and high sensitivity C-Reactive Protein are measured at week 0, 4 and 8. | Obesity | Plasma PAI-1 level at 0, 4, 8 weeks Plasma hsCRP level at 0, 4, 8 weeks Plasma TNF-a level at 0, 4, 8 weeks | null | 2 | arm 1: Patients receive Pentoxifylline 400 mg po TID for 8 weeks. arm 2: Patients take a placebo TID for 8 weeks. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 400mg PO TID x 8 weeks intervention 2: PO TID x 8 weeks | intervention 1: Pentoxifylline intervention 2: Placebo | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 37 | 0 | 0 | 0 | NCT00770328 | 1COMPLETED | 2009-06-01 | 2003-05-01 | Vanderbilt University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 6 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the treatment of complicated Urinary Tract Infections (UTIs) in adults. | null | Urinary Tract Infections | null | 2 | arm 1: MK0826 (ertapenem) arm 2: meropenem | [
0,
1
] | 2 | [
0,
0
] | intervention 1: A single dose of 1.0g IV infused over a 30 minute interval at hour 0 intervention 2: 500 mg IV infused over a 30 minute interval at hours 0, 8, and 16 for at least 4 days | intervention 1: MK0826 (ertapenem) intervention 2: Comparator: meropenem | 0 | null | 6 | 0 | 0 | 0 | NCT00771316 | 6TERMINATED | 2009-06-01 | 2008-12-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis. | null | Cystic Fibrosis Pancreatic Exocrine Insufficiency | Cystic Fibrosis Pancreatic Exocrine Insufficiency | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 3,000, 6,000 and 12,000 unit Lipase Capsules | intervention 1: Pancrelipase Delayed Release | 12 | Boise | Idaho | United States | -116.20345 | 43.6135
Louisville | Kentucky | United States | -85.75941 | 38.25424
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Detroit | Michigan | United States | -83.04575 | 42.33143
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Long Branch | New Jersey | United States | -73.99236 | 40.30428
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Hershey | Pennsylvania | United States | -76.65025 | 40.28592 | 18 | 0 | 0 | 0 | NCT00775528 | 1COMPLETED | 2009-06-01 | 2009-04-01 | Solvay Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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