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interventionModel
string
primaryPurpose
class label
masking
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healthyVolunteers
bool
sex
class label
oversightHasDmc
bool
briefSummary
string
detailedDescription
string
conditions
string
conditionsKeywords
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protocolPdfText
string
numArms
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armDescriptions
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armGroupTypes
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locationDetails
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nctid
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[ 3 ]
104
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it is no longer present by conventional imaging and tumor markers from serum and cerebrospinal fluid. Radiation therapy uses ...
OBJECTIVES: * Determine the response rate of patients with non-germinomatous germ cell tumors treated with neoadjuvant chemotherapy. * Determine the progression-free survival and overall survival of patients treated with neoadjuvant chemotherapy with or without second-look surgery followed by radiotherapy with or with...
Brain Tumor Central Nervous System Tumors Childhood Germ Cell Tumor
childhood central nervous system germ cell tumor childhood teratoma recurrent childhood malignant germ cell tumor childhood central nervous system choriocarcinoma childhood central nervous system embryonal tumor childhood central nervous system germinoma childhood central nervous system mixed germ cell tumor childhood ...
null
1
arm 1: Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Ind...
[ 0 ]
9
[ 0, 0, 0, 0, 3, 3, 3, 3, 4 ]
intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: craniospinal irradiation
intervention 1: carboplatin intervention 2: etoposide intervention 3: ifosfamide intervention 4: thiotepa intervention 5: adjuvant therapy intervention 6: conventional surgery intervention 7: neoadjuvant therapy intervention 8: peripheral blood stem cell transplantation intervention 9: radiation therapy
106
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Downey | California | United States | -118.13257 | 33.94001 Loma Linda | California | United States | -117.26115 | 34.04835 Long Beach | Cal...
0
NCT00047320
[ 3 ]
18
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol. The etiology of NASH is unclear, but it is commonly associated with diabetes, obesity, and insulin resistance. Several pilot studies, including a study of pioglitazone a...
Nonalcoholic steatohepatitis (NASH) is a common liver disease that resembles alcoholic hepatitis but occurs in persons who drink little or no alcohol. The etiology of NASH is unclear, but it is commonly associated with diabetes, obesity, and insulin resistance. Several pilot studies, including a study of pioglitazone a...
Hepatitis
Insulin Resistance Obesity Fatty Liver Cirrhosis Diabetes Pioglitazone Thiazolidinediones Peroxisome Proliferator-Advanced Receptor Gamma PPAR Gama Nonalcoholic Steatohepatitis Hepatitis Non-Alcoholic Steatohepatitis NASH
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Pts receive drug in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum ALT levels do not fall to normal by the 1 year pt; if pts have a biochemical response, drug is continued for 3 years,
intervention 1: Actos (Pioglitazone)
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00062764
[ 3 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving temozolomide together wi...
OBJECTIVES: Primary * Determine the intracranial response rate in patients with brain metastasis secondary to non-small cell lung cancer treated with whole brain radiotherapy and temozolomide. Secondary * Determine the time to radiological progression in patients treated with this regimen. * Determine the time to n...
Lung Cancer Metastatic Cancer
recurrent non-small cell lung cancer stage IV non-small cell lung cancer squamous cell lung cancer adenocarcinoma of the lung large cell lung cancer bronchoalveolar cell lung cancer adenosquamous cell lung cancer tumors metastatic to brain
null
1
arm 1: Temozolomide:administered orally. Radiation: whole brain radiation therapy
[ 0 ]
2
[ 0, 4 ]
intervention 1: Temozolomide (TMZ) to be given at a dose of 75 mg/m2/day for 14 days, starting on D1 of whole brain radiotherapy (WBRT). Three weeks after completion of WBRT, TMZ will be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28-days,for an additional two cycles. interv...
intervention 1: Temozolomide intervention 2: Radiation therapy
0
null
0
NCT00080938
[ 3 ]
41
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also be studied.
Lenalidomide blocks the activity of a substance in the blood called tumor necrosis factor alpha. Tumor necrosis factor alpha is a substance that is believed to prevent new blood cells from forming in the bone marrow. Lenalidomide is also believed to help the body's immune system fight diseases. Before treatment starts...
Myelofibrosis
Myelofibrosis Philadelphia negative myeloproliferative disorder CC-5013 Lenalidomide Revlimid Antiangiogenesis
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 10 mg orally (2 capsules) daily
intervention 1: CC-5013
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00087672
[ 3 ]
73
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.
Some people with depression do not respond well to antidepressant treatment. S-adenosyl methionine (SAMe) is a naturally occurring compound that may have antidepressant effects. SAMe may also enhance the effectiveness of other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs). This study will det...
Depression
Selective Serotonin Reuptake Inhibitors S-adenosyl Methionine SSRI SAMe
null
2
arm 1: Participants receiving the oral SAMe tosylate arm 2: Participants receiving placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Oral SAMe tosylate, up to 1600 mg per day for 6 weeks intervention 2: Placebo to be taken daily for 6 weeks
intervention 1: S-adenosyl methione (SAMe) intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00093847
[ 0 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. The effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocogniti...
We will perform an 18-month randomized, double-blinded, placebo-controlled study among relatively androgen deficient women with HIV, to determine the effects of testosterone administration on lean body mass. The administered dose will be 300 micrograms twice a week vs. identical placebo in the form of a transdermal pre...
HIV Infection
HIV women androgen Treatment Experienced
null
2
arm 1: 300 micrograms applied twice a week arm 2: placebo patch (0 micrograms of testosterone)applied twice a week
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 300 micrograms twice a week intervention 2: Placebo patch (0 micrograms of testosterone) applied twice a week
intervention 1: 1 Transdermal Testosterone (Patch) intervention 2: 2 Placebo Patch
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00095212
[ 4 ]
682
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
Macular edema is a major cause of vision loss in patients with CRVO and BRVO. Both CRVO and BRVO are common retinal problems and are caused by a blockage in one of the large retinal veins (central retinal vein occlusion - CRVO) or smaller retinal veins (branch retinal vein occlusion - BRVO). Currently, there is no effe...
Macular Edema, Cystoid Retinal Vein Occlusion
macular edema central retinal vein occlusion (CRVO) branch retinal vein occlusion (BRVO)
Prot_SAP_000.pdf: The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study February 10, 2008 The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide ...
6
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
[ 1, 1, 1, 1, 1, 1 ]
3
[ 10, 0, 0 ]
intervention 1: CRVO: observation; BRVO: standard care intervention 2: 1 mg dose intervention 3: 4 mg
intervention 1: Standard Care intervention 2: intravitreal triamcinolone injection intervention 3: intravitreal triamcinolone injection
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
0
NCT00105027
[ 4 ]
19
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and docetaxel may make tumor cells more sensitive to r...
OBJECTIVES: Primary * Compare overall survival of patients with newly diagnosed favorable prognosis stage IIIA non-small cell lung cancer treated with neoadjuvant cisplatin and docetaxel with vs without thoracic conformal radiotherapy followed by surgical resection and docetaxel. Secondary * Compare median and prog...
Lung Cancer
stage IIIA non-small cell lung cancer adenocarcinoma of the lung large cell lung cancer squamous cell lung cancer bronchoalveolar cell lung cancer
null
2
arm 1: Induction/surgery/consolidation arm 2: Induction/radiation/surgery/cosolidation
[ 5, 5 ]
8
[ 2, 2, 0, 0, 3, 3, 3, 4 ]
intervention 1: Consolidation chemotherapy intervention 2: Consolidation chemotherapy intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None
intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: cisplatin intervention 4: docetaxel intervention 5: adjuvant therapy intervention 6: conventional surgery intervention 7: neoadjuvant therapy intervention 8: radiation therapy
76
Anchorage | Alaska | United States | -149.90028 | 61.21806 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Concord | California | United States | -122.03107 | 37.97798 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento |...
0
NCT00113386
[ 4 ]
15
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more tha...
OBJECTIVES: Primary * Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy, cisplatin, and paclitaxel vs cisplatin-based chemotherapy alone. Secondary * Compare progression-free survival of patients trea...
Head and Neck Cancer
recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent metastatic squamous neck cancer with occult primary recurrent lymphoepithelioma of the oropharyn...
null
2
arm 1: Radiotherapy/paclitaxel/cisplatin/filgrastim arm 2: Cisplatin/fluorouracil/paclitaxel/docetaxel
[ 5, 5 ]
6
[ 2, 0, 0, 0, 0, 4 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None
intervention 1: filgrastim intervention 2: cisplatin intervention 3: docetaxel intervention 4: fluorouracil intervention 5: paclitaxel intervention 6: radiation therapy
125
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Auburn | California | United States | -121.07689 | 38.89657 Cameron Park | California | United States | -120.98716 | 38.66879 Carmichael | Cali...
0
NCT00113399
[ 4 ]
1,052
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.
null
Rheumatoid Arthritis
abatacept, methotrexate, erosive RA
null
2
arm 1: abatacept 10 mg/kg intravenous (IV) + methotrexate arm 2: placebo IV + methotrexate
[ 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months intervention 2: placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months intervention 3: Oral, titrated to at least 15 mg per week not to exceed 20 mg per week adm...
intervention 1: Abatacept intervention 2: placebo intervention 3: methotrexate
89
Huntsville | Alabama | United States | -86.58594 | 34.7304 Huntington Beach | California | United States | -117.99923 | 33.6603 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Trumbull | Connecticut | United States | -73.20067 | 41.24287 Indianapolis | Indiana | United States | -86.15804 | 39.76838 ...
0
NCT00122382
[ 3 ]
62
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
Study Design: This ia a Phase II study. Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary peritoneal and papillary serous mullerian tumors will be recruited. Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after surgery for 6-8 cycles eve...
Ovarian cancer is diagnosed in approximately 26,000 American women each year, and is the leading cause of death from gynecologic cancers. Difficult to detect, the disease typically presents only when advanced. Ovarian cancer is among the most sensitive of solid tumors to chemotherapy. However, the majority of patients ...
Ovarian Cancer
Carboplatin Paclitaxel Bevacizumab Ovarian Cancer
null
1
arm 1: Paclitaxel carboplatin bevacizumab
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Given intravenously intervention 2: Given intravenously intervention 3: Given intravenously
intervention 1: Paclitaxel intervention 2: Carboplatin intervention 3: Bevacizumab
0
null
0
NCT00129727
[ 3 ]
211
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children. The purpose of this study is to determine the efficacy and safety of sodium nitroprusside in children who will be having surgery, and who require blood pressure lowering in order to dec...
The trial is a multicenter randomized, double-blind, parallel group, dose-ranging, effect-controlled study examining the effects of sodium nitroprusside in pediatric subjects requiring relative hypotension during a surgical or medical procedure. The goal is to establish the starting and maximum infusion rates that affo...
Hypotension
children sodium nitroprusside controlled hypotension dose-response pharmacokinetics pharmacodynamics safety efficacy
null
4
arm 1: Infusion of Sodium Nitroprusside began only after a 5-minute period of stable anesthesia or sedation (no changes in dosages). The infusion rate during the blinded study drug period was increased in a step-wise fashion to the full dose rate as follows: 5 ± 1 minutes at 1/3 of the full rate; 5 ± 1 minutes at 2/3 o...
[ 1, 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL o...
intervention 1: Nitroprusside intervention 2: Nitroprusside intervention 3: Nitroprusside intervention 4: Nitroprusside
1
Stanford | California | United States | -122.16608 | 37.42411
0
NCT00135668
[ 3 ]
34
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.
Lung or breathing problems can develop several months to years following a bone marrow transplant. In some cases, these breathing problems develop without any signs of germs or infection in the lungs. The name for this type of breathing problem is called "Sub-Acute Lung Injury". Sub-acute lung injury often develops man...
Lung Injury, Acute Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans
Enbrel Stem Cell Transplantation Lung Injury
null
1
arm 1: Etanercept for lung injury
[ 0 ]
1
[ 0 ]
intervention 1: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
intervention 1: Etanercept
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
0
NCT00141726
[ 0 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Malignant infantile osteopetrosis (MIOP) is a rare fatal genetic disorder that is characterized by the bone's inability to regulate remodeling. The only curative therapy is hematopoietic stem cell transplantation. Stem cells provided from an HLA identical matched sibling donor is the standard of care, but not feasible ...
The primary objective of this trial will be answered strictly by those patients enrolled who receive a haploidentical stem cell donor graft. Patients with a matched sibling donor will be offered participation in this clinical trial and will receive a standard myeloablative conditioning regimen followed by the infusion...
Osteopetrosis
Osteopetrosis Autosomal recessive bone disease Haploidentical stem cell transplantation Allogeneic stem cell transplantation T-cell depletion methodology Miltenyi Biotec CliniMACS stem cell selection device
null
1
arm 1: None
[ 5 ]
3
[ 3, 1, 0 ]
intervention 1: An infusion of HLA partially matched family member donor stem cells processed through the use of the investigational Miltenyi Biotec CliniMACS device. intervention 2: Stem cell selection device intervention 3: Haploidentical stem cell transplant recipients will receive a reduced intensity conditioning r...
intervention 1: Stem Cell Transplantation intervention 2: Miltenyi Biotec CliniMACS intervention 3: Systemic chemotherapy and antibodies
1
Memphis | Tennessee | United States | -90.04898 | 35.14953
0
NCT00145587
[ 5 ]
76
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.
A significant number of schizophrenics exhibit partial or no response to typical antipsychotic medications. Clozapine has been shown to be more effective in treating schizophrenia than typical antipsychotic drugs. However, only an estimated 30% to 60% of people who are unresponsive to treatment with typical antipsychot...
Schizophrenia Psychotic Disorders
Schizophrenia Clozapine Treatment Combination Unresponsive Schizoaffective Disorders
null
2
arm 1: Participants will receive encapsulated placebo made to match active drug arm 2: Participants will receive pimozide flexible dosing
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Each capsule of active treatment will contain 2 mg of pimozide. Dosing will be flexible and will range from a minimum of 2 mg per day to 8 mg per day. Dosing will begin at Week 1 with 1 capsule per day. This will be slowly titrated at a rate of 1 capsule per week to a maximum of 4 capsules depending upo...
intervention 1: Pimozide intervention 2: Placebo
3
New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427 W. Brentwood | New York | United States | N/A | N/A
0
NCT00158223
[ 5 ]
240
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
null
Secondary Amenorrhea
To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles intervention 2: 400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
intervention 1: PROMETRIUM® 300 mg intervention 2: PROMETRIUM® 400 mg
42
Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | United States | -86.29997 | 32.36681 Tucson | Arizona | United States | -110.92648 | 32.22174 Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Carmichael | California | United States | -121.32828 | 38.61713 Encinitas | California |...
0
NCT00160199
[ 3 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.
null
Non-small Cell Lung Cancer
null
2
arm 1: None arm 2: None
[ 0, 0 ]
5
[ 0, 0, 0, 0, 4 ]
intervention 1: After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles. inte...
intervention 1: gemcitabine intervention 2: docetaxel intervention 3: cisplatin intervention 4: etoposide intervention 5: radiation therapy
15
Denver | Colorado | United States | -104.9847 | 39.73915 South Bend | Indiana | United States | -86.25001 | 41.68338 Baltimore | Maryland | United States | -76.61219 | 39.29038 Kalamazoo | Michigan | United States | -85.58723 | 42.29171 Kansas City | Missouri | United States | -94.57857 | 39.09973 St Louis | Missouri |...
0
NCT00191139
[ 0 ]
24
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.
Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.
Urolithiasis
urolithiasis
null
2
arm 1: Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. arm 2: Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage. intervention 2: Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.
intervention 1: Flomax intervention 2: Sugar pill
1
Atlanta | Georgia | United States | -84.38798 | 33.749
0
NCT00209131
[ 2, 3 ]
23
RANDOMIZED
SEQUENTIAL
0TREATMENT
0NONE
false
0ALL
true
The objectives of this study are to: 1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1) 2. To determine the maximum-tolerated dose (MTD) when capecitabine * oxaliplatin in a combination regimen with capecitabine and rad...
Part of the treatment plan for this study is surgical removal of the tumor that is planned to occur 6 to 8 weeks after completion of radiotherapy (XRT). This study consists of 2 distinct phases (Phase 1 and Phase 2). In Phase 1, the objectives are to 1. Assess dose-limiting toxicities (DLTs) and 2. Determine a maximu...
Rectal Cancer Colo-rectal Cancer
null
4
arm 1: * Cetuximab 250 mg/m² / week * Capecitabine 800 mg/m² * Radiotherapy (XRT) * Oxaliplatin 100 mg/m², Days 2 and 23 arm 2: * Cetuximab 250 mg/m² / week * Capecitabine 700 mg/m² * Radiotherapy (XRT) * Oxaliplatin 85 mg/m², Days 2 and 23 arm 3: * Cetuximab 250 mg/m² / week * Capecitabine 800 mg/m² * Radiotherapy (XR...
[ 0, 0, 0, 0 ]
5
[ 0, 0, 0, 4, 0 ]
intervention 1: Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA) intervention 2: Oxaliplatin is a cancer medication ...
intervention 1: Cetuximab intervention 2: Oxaliplatin intervention 3: Capecitabine intervention 4: Radiotherapy intervention 5: Diphenhydramine hydrochloride (HCl)
1
Stanford | California | United States | -122.16608 | 37.42411
0
NCT00226941
[ 5 ]
27
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The goal of the investigators' study is to further understand the potentially beneficial effects of statin therapy in patients with heart failure. It is hypothesized that statins will 1) increase the heart's pumping ability 2) improve functioning of the sympathetic nervous system and 3) decrease immune activation in he...
Recent evidence suggests that HMG-Coenzyme A (statin) therapy may be associated with improved survival in both ischemic and non-ischemic heart failure (HF). Large, randomized outcome studies of statins in HF are currently underway, but these trials will not address underlying mechanisms. The aim of the study is to inve...
Heart Failure, Congestive
Randomized Controlled Trial Hydroxymethylglutaryl-CoA Reductase Inhibitors Sympathetic Nervous System Ventricular Remodeling Chemokines
null
2
arm 1: atorvastatin 10mg QD x 3 months arm 2: matched placebo QD x 3 months
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: atorvastatin 10mg PO QD intervention 2: matched placebo Qd x 3 months
intervention 1: atorvastatin intervention 2: placebo
1
Los Angeles | California | United States | -118.24368 | 34.05223
0
NCT00233480
[ 3 ]
42
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of rituximab, administered at two different regimens for 2 years, in patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of methotrexate (MTX).
null
Rheumatoid Arthritis
Rituxan RA
null
2
arm 1: Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant). ...
[ 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Minimum of 1 mg/day oral (or folinic acid 5 mg/week) intervention 2: 15-25 mg/week oral or parenteral (10-14 mg/week if intolerant) intervention 3: 100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusi...
intervention 1: folate intervention 2: methotrexate intervention 3: methylprednisolone intervention 4: Placebo intervention 5: Rituximab
0
null
0
NCT00243412
[ 2, 3 ]
144
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the safety and effectiveness of the intetumumab, alone and in combination with dacarbazine, in patients with stage 4 melanoma.
This is a Phase 1/2, multi-center, randomized (the study medication is assigned by chance) study. This study will be conducted in 2 Phases (Phase 1 and Phase 2). Phase 1 of this study will be non-randomized, open-label (all people know the identity of the intervention) and dose-escalation phase. It includes screening p...
Melanoma
Melanoma Neoplasm CNTO 95 Dacarbazine Intetumumab
null
9
arm 1: Intetumumab will be administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation...
[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Intetumumab will be administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). In Phase 2, i...
intervention 1: Intetumumab intervention 2: Dacarbazine intervention 3: Placebo
32
Scottsdale | Arizona | United States | -111.89903 | 33.50921 La Jolla | California | United States | -117.2742 | 32.84727 Santa Monica | California | United States | -118.49138 | 34.01949 Walnut Creek | California | United States | -122.06496 | 37.90631 Aurora | Colorado | United States | -104.83192 | 39.72943 Washingt...
0
NCT00246012
[ 3 ]
37
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at...
null
Liver Neoplasms Unresectable Hepatocellular Carcinoma
Liver neoplasms, sunitinib, Phase 2
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
intervention 1: Sunitinib (SU011248)
8
Clichy | N/A | France | 2.30952 | 48.90018 Rennes | N/A | France | -1.67429 | 48.11198 Saint Herrblain Cedex | N/A | France | N/A | N/A Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 ...
0
NCT00247676
[ 3 ]
23
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to find out if the combination of bortezomib (Velcade), dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's macroglobulinemia.
* This is an open-label study which means both the patient and the doctor will know what drugs and doses the patient is receiving throughout the study. * Patients will receive 8 cycles of study treatment with bortezomib, dexamethasone and rituximab. Each cycle is 21 days long. Therapy is given on the first, fourth, eig...
Waldenstrom's Macroglobulinemia
bortezomib dexamethasone rituximab
null
1
arm 1: A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles intervention 2: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles intervention 3: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles
intervention 1: Bortezomib intervention 2: Dexamethasone intervention 3: Rituximab
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00250926
[ 3 ]
51
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).
null
Carcinoma, Renal Cell
Ph2, RCC, SU011248, SUNITINIB
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops
intervention 1: SU011248 capsule
11
Akita | Akita | Japan | 140.11667 | 39.71667 Sapporo | Hokkaido | Japan | 141.35 | 43.06667 Tsukuba | Ibaragi | Japan | 140.11667 | 36.08333 Osaka | Osaka | Japan | 135.50107 | 34.69379 Sayama | Osaka | Japan | 135.56298 | 34.51685 Hamamatsu | Shizuoka | Japan | 137.73333 | 34.7 Sunto-gun | Shizuoka | Japan | N/A | N/A...
0
NCT00254540
[ 3 ]
21
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Purpose of this study: There is some evidence that the best treatment for head and neck cancer involves a combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses special medications. This study use...
Patients presenting with locally advanced squamous cell carcinomas of head and neck (SCCHN) continue to represent a significant therapeutic challenge. The bulk of tumor burden often proves to be overwhelming for conventional radiotherapy. Attempts to improve upon these poor outcomes have led investigators to explore se...
Head and Neck Cancer
Head and Neck cancer
null
1
arm 1: EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.
[ 0 ]
4
[ 0, 0, 0, 1 ]
intervention 1: Amifostine will be given at dose of 500 mg IV within one hour before radiation intervention 2: Carboplatin for 100 mg/m2 and will be administered after the taxol infusion intervention 3: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose intervention 4: Radiation will be given at a dose...
intervention 1: Amifostine intervention 2: Carboplatin intervention 3: Taxol intervention 4: Radiotherapy
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
NCT00270790
[ 3 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Phase 2 study, conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation.
This Phase 2 study will be conducted in patients with Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma undergoing high-dose chemotherapy and autologous stem cell transplantation. Patients will be randomized to receive either LAD 11.25 mg 3 Month treatment or placebo and all patients ...
Hodgkin Disease Lymphoma, Non-Hodgkin Multiple Myeloma Mantle Cell Lymphoma
Bone marrow transplantation Hematopoietic stem cell transplantation Hodgkin's disease non-Hodgkin's lymphoma multiple myeloma
null
2
arm 1: Three intramuscular injections LAD 11.25 mg 3 Month treatment administered approximately 3 months apart. arm 2: Three intramuscular injections of matched placebo administered approximately 3 months apart.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: LAD intramuscular injection 11.25 mg, 3 month duration. To stimulate immune response, a subcutaneous key limpet hemocyanin (KLH) vaccination injection (1 mg) was administered at Month 6. intervention 2: Matched placebo intramuscular injection, 3 month duration. To stimulate immune response, a subcutaneo...
intervention 1: Leuprolide acetate depot (LAD) 11.25 mg 3 Month intervention 2: Matched placebo
4
St Louis | Missouri | United States | -90.19789 | 38.62727 New York | New York | United States | -74.00597 | 40.71427 Durham | North Carolina | United States | -78.89862 | 35.99403 Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00275262
[ 3 ]
10
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.
We propose to do this with a single site, ten week, pilot study of 40 school age children, ages 6-17, with Attention-Deficit/ Hyperactivity Disorder (ADHD) and moderate or greater impairment (C-GAS \< 55) who show ADHD symptoms despite a trial in the community with their primary care practitioner with either of two of ...
Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder ADHD Treatment resistant Partial responder Non-responder Atypical Antipsychotic
null
2
arm 1: This treatment arm (also called the "combination arm") consists of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus augmentation with aripiprazole. Aripiprazole pills are taken once daily over a peri...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: double blind capsules (abilify or placebo) taken once daily, up to 10mg. intervention 2: double blind capsules (abilify or placebo) taken once daily, up to 10mg.
intervention 1: aripiprazole intervention 2: Sugar pill
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00279409
[ 2 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study examined the safety and potential efficacy of the monoclonal antibody efalizumab (Raptiva) for treating sight-threatening uveitis (eye inflammation). Efalizumab controls the activity of white blood cells called lymphocytes that cause inflammation. The drug is currently approved in the United States to treat ...
Background: Uveitis refers to intraocular inflammatory diseases that are an important cause of visual loss. Standard systemic immunosuppressive medications for uveitis can cause significant adverse effects. Consequently, an effective treatment with a safer side effect profile is highly desirable. Aims: This protocol e...
Uveitis Macular Edema
OCT Retinal Disease Adhesion Molecule Ocular Inflammation Raptiva Macular Edema Uveitis Immunosuppression
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Participants who qualified for the study received weekly subcutaneous treatments of efalizumab, with the first dose being a test dose of 0.7 mg/kg and subsequent doses of 1 mg/kg (not to exceed 200 mg per dose), for a total treatment duration of 16 weeks.
intervention 1: Efalizumab
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00280826
[ 3 ]
21
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
1FEMALE
true
Decreased bone strength is a serious medical problem present in many women with Anorexia Nervosa, or disordered eating. Women with weaker bones are more likely to suffer broken bones than women with normal bone strength. We are investigating whether a hormone that is naturally produced by the human body, called growth...
* Twelve week study * Eight visits, six of which can be conducted at your home physician's office * Two bone density scans * Hormonal and nutritional evaluations
Anorexia Nervosa Osteopenia Osteoporosis Eating Disorders
Anorexia Nervosa Eating disorder Bone Growth hormone Osteopenia Osteoporosis
null
2
arm 1: Treatment with rHGH arm 2: Treatment with Placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Dosage increased in steps for first four weeks. Self injection qd x 12 weeks intervention 2: Administered as Arm 1, rHGH active Injection qd x 12 weeks Dosage increase over four weeks
intervention 1: Recombinant Human Growth Hormone intervention 2: Placebo for Recombinant Human Growth Hormone
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00283595
[ 4 ]
489
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
true
Study is to compare antifungal prophylaxis of Voriconazole and Itraconazole in subjects who have had a Stem Cell Transplant. The success of the end point will be measured using evidence of Infection, drug compliance and survival.
null
Antifungal Prophylaxis of Invasive Fungal Infections
null
2
arm 1: None arm 2: None
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Prophylaxis intervention 2: Prophylaxis
intervention 1: Itraconazole intervention 2: Vfend - voriconazole
49
Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Montreal | Quebec | Canada | -73.58781 | 45.50884 Bmo | N/A | Czechia | N/A | N/A Prague | N/A | Czechia ...
0
NCT00289991
[ 2 ]
22
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.
null
Breast Neoplasms
advanced sunitinib (Sutent) docetaxel Phase 1B
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision intervention 2: Taxotere 75 mg/m2 iv, once every 3 weeks
intervention 1: Sunitinib (Sutent) intervention 2: Taxotere
3
Brussels | N/A | Belgium | 4.34878 | 50.85045 Milan | N/A | Italy | 12.59836 | 42.78235 Stockholm | N/A | Sweden | 18.06871 | 59.32938
0
NCT00291577
[ 3 ]
21
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
Study investigating the use of pimecrolimus 1% cream for oral lichen planus
Lichen planus (LP) is an idiopathic inflammatory dermatosis of the skin and mucous membranes. Cutaneous lesions present as pink polygonal papules on the flexor wrists, trunk, thighs, shin and the dorsal hands. Oral lichen planus (OLP) represents a unique subset of LP and is often the sole manifestation of this disease....
Oral Lichen Planus
oral lichen planus, pimecrolimus 1% cream
null
2
arm 1: "During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be appl...
[ 1, 2 ]
1
[ 0 ]
intervention 1: pimecrolimus cream or matching placebo BID for 6 weeks
intervention 1: Pimecrolimus 1% cream
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
0
NCT00297037
[ 4 ]
926
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.
null
Carcinoma, Non-Small Cell Lung
Non-Small Cell Lung Cancer NSCLC
null
2
arm 1: Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 ...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), \[400 mg orally, twice daily\] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml\*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Soraf...
intervention 1: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel intervention 2: Carboplatin plus Paclitaxel
202
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Springdale | Arkansas | United States | -94.12881 | 36.18674 Anaheim | California | U...
0
NCT00300885
[ 3 ]
14
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggr...
Study Design: Fifteen patients with DSM-IV diagnoses of Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS) will be enrolled in this 12-week open-label study. Parents of potential subjects will do a preliminary phone screen, followed by a clinical evaluation by a psychiatri...
Autism Asperger's Disorder Pervasive Developmental Disorder
behavioral problems aggression autism aripiprazole
null
1
arm 1: aripiprazole monotherapy, begun at 2.5 mg or 5.0 mg based on clinical impression and severity of aggression and agitation. Dose to be adjusted in not more than 5 mg increments, weekly. The lowest effective dose will be used up to a maximum daily dose of 20 mg.
[ 0 ]
1
[ 0 ]
intervention 1: open-label, flexible-dosing
intervention 1: Aripiprazole
1
Medford | Massachusetts | United States | -71.10616 | 42.41843
0
NCT00308074
[ 3 ]
75
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.
null
Breast Neoplasms Neoplasm Metastasis
Advanced Breast Cancer
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.
intervention 1: SKI-606 (Bosutinib)
15
Duarte | California | United States | -117.97729 | 34.13945 Santa Monica | California | United States | -118.49138 | 34.01949 Tampa | Florida | United States | -82.45843 | 27.94752 Cleveland | Ohio | United States | -81.69541 | 41.4995 Darlinghurst | New South Wales | Australia | 151.21925 | -33.87939 Dijon | N/A | Fra...
0
NCT00319254
[ 2 ]
42
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation C...
null
Metastatic Breast Cancer
null
3
arm 1: Participants received 25 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days. arm 2: Participants received 30 mg/m\^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m\^2 epirubicin every 21 days. arm 3: Par...
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Infusion, intravenous (IV), Cycle = 21 days. Dose escalation study. intervention 2: Infusion, intravenous (IV): 75 mg/m\^2. Cycle = 21 days, up to 10 cycles or cumulative dose of 800 mg/m².
intervention 1: Ixabepilone intervention 2: Epirubicin
2
Toulouse | N/A | France | 1.44367 | 43.60426 Milan | N/A | Italy | 12.59836 | 42.78235
0
NCT00322374
[ 4 ]
1,428
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
0ALL
false
This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for cancer.
OBJECTIVES: Primary * Compare the overall activity and effects of APF530 versus palonosetron hydrochloride in combination with dexamethasone for prophylaxis of acute- or delayed-onset, chemotherapy-induced nausea and vomiting in patients undergoing moderately or highly emetogenic chemotherapy for cancer. Secondary ...
Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific
nausea and vomiting unspecified adult solid tumor, protocol specific
null
3
arm 1: Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses. arm 2: Patients receive APF530 SC, placebo IV, and dexamethasone I...
[ 1, 0, 0 ]
4
[ 0, 0, 0, 10 ]
intervention 1: Given subcutanously intervention 2: Given IV and orally intervention 3: Given IV intervention 4: Given subcutanously or IV
intervention 1: APF530 intervention 2: dexamethasone intervention 3: Palonosetron Hydrochloride intervention 4: placebo
52
Anniston | Alabama | United States | -85.83163 | 33.65983 Glendale | Arizona | United States | -112.18599 | 33.53865 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Anaheim | California | United States | -117.9145 | 33.83529 Campbell | California | ...
0
NCT00343460
[ 4 ]
21
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
3TRIPLE
false
0ALL
true
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy a...
OBJECTIVES: Primary * Compare the efficacy of palifermin vs placebo, in terms of burden of acute mucositis (defined to be 105 days \[15 weeks\] or less from the start of treatment), in patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx undergoing concurrent radiotherapy and c...
Head and Neck Cancer Mucositis Pain Radiation Toxicity
mucositis pain radiation toxicity stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell ca...
null
2
arm 1: Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients. arm 2: Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
[ 0, 2 ]
5
[ 2, 0, 10, 3, 4 ]
intervention 1: Four doses of palifermin, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19. intervention 2: Patients will receive cisplatin (100 mg/m2) administered intravenously on day...
intervention 1: palifermin intervention 2: cisplatin intervention 3: placebo intervention 4: neck dissection intervention 5: radiation therapy
48
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Auburn | California | United States | -121.07689 | 38.89657 Burbank | California | United States | -118.30897 | 34.18084 Cameron Park | California | United States | -120.98716 | 38.66879 Carmichael | California | United States | -121.32828 | 38.61713 Chico | ...
0
NCT00360971
[ 4 ]
51
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks
This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.
Anemia Chronic Kidney Disease
Quality of Life Chronic Kidney Disease Anemia
null
2
arm 1: Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months. arm 2: Single-blind placebo administered by subcutaneous injection (SC) every other week until week...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion. intervention 2: Prefilled syringe placebo, to...
intervention 1: Darbepoetin alfa intervention 2: Placebo
0
null
0
NCT00364845
[ 4 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is an open label, randomized, comparative, multi-center study. Subjects will be screened within 2 weeks prior to study entry to establish eligibility. Subjects who meet all the selection criteria will be randomly assigned 1:1 to (1) once-a-week, subcutaneous Pegylated interferon alfa-2b (PegIntron) (1.5 mcg/kg bod...
null
Hepatitis B, Chronic (CHB)
Hepatitis B virus Pegylated interferon alfa-2b (PegIntron)
null
2
arm 1: PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase arm 2: Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
[ 0, 1 ]
2
[ 2, 0 ]
intervention 1: Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks intervention 2: 10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks
intervention 1: Pegylated interferon alfa-2b (PegIntron) intervention 2: Adefovir dipivoxil (adefovir)
0
null
0
NCT00371761
[ 3 ]
14
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well sunitinib works in treating patients with idiopathic myelofibrosis. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells.
PRIMARY OBJECTIVE: I. Assess the response rate and the duration of response in patients with idiopathic myelofibrosis treated with sunitinib malate. SECONDARY OBJECTIVE: I. Assess the safety of sunitinib malate in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral sunitinib ma...
Accelerated Phase Chronic Myelogenous Leukemia Acute Undifferentiated Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;1...
null
1
arm 1: Patients receive oral sunitinib malate once daily for 6 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: Given PO
intervention 1: sunitinib malate
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00387426
[ 4 ]
77
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in s...
ADHD is often treated with stimulant medications, which have demonstrated short-term efficacy in numerous trials. However, treatment is often discontinued prematurely. Although ADHD often persists through adolescence, approximately half of all children who are treated with a stimulant medication discontinue treatment w...
Attention Deficit Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder sleep side effects stimulants
null
2
arm 1: Subjects are given the Focalin XR first (dexmethylphenidate) for four weeks with a randomized placebo week followed by Adderall XR (mixed amphetamine salts) for four weeks with a randomized placebo week. arm 2: Subjects are given the Adderall XR (mixed amphetamine salts) for four weeks with a randomized placebo ...
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 10, 20, 25-30 mg. intervention 2: 10, 20, 25-30 intervention 3: randomized placebo week during each 4 week period
intervention 1: Dexmethylphenidate intervention 2: Mixed Amphetamine Salts, ER intervention 3: placebo
2
Chicago | Illinois | United States | -87.65005 | 41.85003 Northbrook | Illinois | United States | -87.82895 | 42.12753
0
NCT00393042
[ 3 ]
138
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration
null
Choroid Neovascularization Age-Related Macular Degeneration
null
4
arm 1: AGN 211745 Solution 1000 ug arm 2: AGN 211745 Solution 300 ug arm 3: AGN 211745 Solution 100 ug arm 4: Ranibizumab 500 ug
[ 0, 0, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2 intervention 2: AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2 intervention 3: AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2 intervention 4: Ranibizumab 500µg injections at Day 1, Month 1, Month 2
intervention 1: AGN 211745 intervention 2: AGN 211745 intervention 3: AGN 211745 intervention 4: Ranibizumab 500µg
3
Houston | Texas | United States | -95.36327 | 29.76328 Sydney | New South Wales | Australia | 151.20732 | -33.86785 Makati | N/A | Philippines | 121.1226 | 16.412
0
NCT00395057
[ 4 ]
159
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
null
Hepatitis B
hepatitis B hepatitis B Virus (HBV) chronic hepatitis B telbivudine peginterferon
null
3
arm 1: Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peginterferon alpha-2a (PEG-INF)180 μg subcutaneous injection once a week for 52 weeks. arm 2: Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks. arm 3: Peginterferon alpha-2a (PEG- INF) monotherapy: 180 μg subcutane...
[ 0, 0, 1 ]
2
[ 0, 0 ]
intervention 1: 600 mg orally once daily for 104 weeks. intervention 2: 180 μg subcutaneous injection once a week for 52 weeks.
intervention 1: Telbivudine (LdT) intervention 2: peginterferon alpha-2a
1
San Francisco | California | United States | -122.41942 | 37.77493
0
NCT00412750
[ 3 ]
63
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
0ALL
null
The purpose of this study is to identify an effective, well tolerated dose and schedule of romiplostim that is appropriate for the treatment of chemotherapy induced thrombocytopenia (CIT) in patients with non-small cell lung cancer receiving gemcitabine and platinum.
null
Lung Cancer Chemotherapy-Induced Thrombocytopenia Non-Small Cell Lung Cancer Cancer Lung Neoplasms Oncology Solid Tumors Thrombocytopenia
Advanced Non-Small Cell Lung Cancer Chemotherapy Induced Thrombocytopenia CIT NSCLC Stage IIIB NSCLC Stage IV NSCLC Gemcitabine Carboplatin Cisplatin
null
4
arm 1: Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and ge...
[ 2, 0, 0, 0 ]
5
[ 2, 0, 0, 0, 0 ]
intervention 1: Romiplostim is a thrombopoiesis recombinant protein that targets the thrombopoietin (TPO) receptor which results in increased platelet production. intervention 2: Placebo subcutaneous injection. intervention 3: Intravenous infusion intervention 4: Intravenous infusion intervention 5: Intravenous infusio...
intervention 1: Romiplostim intervention 2: Placebo intervention 3: Gemcitabine intervention 4: Carboplatin intervention 5: Cisplatin
113
Glendale | Arizona | United States | -112.18599 | 33.53865 Glendale | Arizona | United States | -112.18599 | 33.53865 Anaheim | California | United States | -117.9145 | 33.83529 Anaheim | California | United States | -117.9145 | 33.83529 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | Cal...
0
NCT00413283
[ 2, 3 ]
80
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The study seeks to assess the safety, pharmacodynamics, pharmacokinetics and efficacy of belinostat (PXD101) administered in combination with carboplatin or paclitaxel or both in patients with solid tumours followed by maximum tolerated dose (MTD) expansion (phase II) in ovarian and bladder cancer patients The clinica...
MTD Expansion I(Phase II): A total of 18-32 patients with epithelial ovarian, primary peritoneal, fallopian tube or mixed mullerian tumours of ovarian origin, in need of relapse treatment will be enrolled. MTD Expansion II (phase II): A total of 15 patients with urothelial (transitional cell) carcinoma of the bladder ...
Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Bladder Cancer
Ovarian cancer Ovarian Neoplasms Primary peritoneal Epithelial ovarian Fallopian tube Bladder cancer belinostat PXD101 mixed mullerian cancer of ovarian origin
null
1
arm 1: Belinostat: 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: Administered IV 2-3 hours after belinostat infusion on day 3 in a 21-day cycle Carboplatin: Administered IV infusion after paclitaxel on day 3 in a 21-day cycle
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: belinostat intervention 2: Paclitaxel intervention 3: Carboplatin
11
Newport Beach | California | United States | -117.92895 | 33.61891 Orlando | Florida | United States | -81.37924 | 28.53834 Covington | Louisiana | United States | -90.10042 | 30.47549 Metairie | Louisiana | United States | -90.15285 | 29.98409 Baltimore | Maryland | United States | -76.61219 | 39.29038 Boston | Massac...
0
NCT00421889
[ 4 ]
300
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender...
null
Hypertension
Children pediatrics High Blood Pressure Hypertension Valsartan enalapril
null
6
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
[ 0, 0, 0, 1, 1, 1 ]
2
[ 0, 0 ]
intervention 1: Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg. intervention 2: Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
intervention 1: Valsartan intervention 2: Enalapril
11
East Hanover | New Jersey | United States | -74.36487 | 40.8201 Sites in Belgium | N/A | Belgium | N/A | N/A Sites in France | N/A | France | N/A | N/A Sites in Germany | N/A | Germany | N/A | N/A Hungary | N/A | Hungary | N/A | N/A Sites in India | N/A | India | N/A | N/A Sites in Italy | N/A | Italy | N/A | N/A Polan...
0
NCT00433836
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
null
Vitreomacular Traction
Vitreomacular Traction Maculopathy VMT PVD
null
5
arm 1: Ocriplasmin 75µg single injection versus sham injection arm 2: Ocriplasmin 125µg single injection versus sham injection arm 3: Ocriplasmin 175µg single injection versus sham injection arm 4: Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-respon...
[ 0, 0, 0, 0, 3 ]
3
[ 0, 0, 0 ]
intervention 1: Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin. intervention 2: Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval. intervention 3: Intravitreal sham injection
intervention 1: ocriplasmin intervention 2: ocriplasmin intervention 3: Sham Comparator
4
Antwerp | N/A | Belgium | 4.40026 | 51.22047 Ghent | N/A | Belgium | 3.71667 | 51.05 Leuven | N/A | Belgium | 4.70093 | 50.87959 München | N/A | Germany | 13.31243 | 51.60698
0
NCT00435539
[ 4 ]
412
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
null
The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip
null
Osteoporosis
Bone Mineral Density (BMD) C-Telopeptides (CTx) dual x-ray absorptiometry (DXA) pro-collagen type 1 N-propeptide (P1NP) teriparatide zoledronic acid Osteoporosis postmenopausal women
null
3
arm 1: Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injec...
[ 1, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Zoledronic acid 5.0 mg in a ready-to-infuse plastic bottle with a total fill volume of 103 mL to allow an infusion of 100 mL total volume corresponding to 5 mg of zoledronic acid. intervention 2: Zoledronic acid matched placebo as a 103 mL solution of sterile water (physiologic 0.9% normal saline) to al...
intervention 1: Zoledronic acid intervention 2: Placebo intervention 3: Teriparatide
33
Birmingham | Alabama | United States | -86.80249 | 33.52066 Beverly Hills | California | United States | -118.40036 | 34.07362 La Mesa | California | United States | -117.02308 | 32.76783 Oakland | California | United States | -122.2708 | 37.80437 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Lake...
0
NCT00439244
[ 4 ]
180
RANDOMIZED
FACTORIAL
0TREATMENT
2DOUBLE
false
0ALL
null
General Note: throughout this record, "Rebif® New Formulation" is used for historical and consistency purposes. Objectives: Primary: To evaluate the efficacy of Rebif® New Formulation (Interferon-beta-1a \[IFN-beta-1a\], RNF), compared to placebo, in subjects with Relapsing Remitting Multiple Sclerosis and active dis...
null
Multiple Sclerosis, Relapsing-Remitting
Subjects with relapsing remitting multiple sclerosis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: RNF will be administered at a dose of 44 mcg subcutaneously three times a week for 40 weeks. intervention 2: Matching placebo will be administered subcutaneously three times a week for 16 weeks. intervention 3: RNF will be administered at a dose of 44 mcg subcutaneously three times a week from Week 17 t...
intervention 1: Rebif® New Formulation (IFN-beta-1a, RNF) intervention 2: Placebo intervention 3: Rebif® New Formulation (IFN-beta-1a, RNF)
0
null
0
NCT00441103
[ 5 ]
8
NON_RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
true
The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions. The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diab...
Following approval by the Institutional Review Board at Baylor College of Medicine 8 adolescents (6 males, 2 females) with type 1 diabetes were recruited to the open-labeled, non-randomized, crossover study. Two male subjects were African American; the remaining subjects were all Caucasian. Six subjects were on insulin...
Type 1 Diabetes Mellitus
pediatric juvenile diabetes mellitus Pediatric type 1 diabetes mellitus
null
2
arm 1: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal arm 2: 30mcg of pramlintide was administered subcutaneously immediately prior to t...
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal. intervention 2: 30mcg of pramlintide was administered subcutaneously imm...
intervention 1: Insulin intervention 2: Pramlintide + Insulin
1
The Bronx | New York | United States | -73.86641 | 40.84985
0
NCT00442767
[ 3 ]
14
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in 2000 new standards for islet transplantation i...
The short term effectiveness of islet transplantation for alleviating hypoglycemia and controlling glucose homeostasis while limiting or even avoiding the nedd for exogenous insulin has been established despite protocol modifications in donor selection, islet preparation or recipient treatment, insulin independence wit...
Type 1 Diabetes Hypoglycemia Metabolic Diseases
diabetes hypoglycemia
null
1
arm 1: Each participant received up to three sequential fresh islet infusions within three months.
[ 0 ]
2
[ 3, 0 ]
intervention 1: Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric ...
intervention 1: islet transplantation intervention 2: daclizumab - sirolimus - tacrolimus
1
Lille | N/A | France | 3.05858 | 50.63297
0
NCT00446264
[ 4 ]
44
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)
null
Pulmonary Hypertension
Pulmonary Arterial Hypertension, PAH
null
1
arm 1: sildenafil citrate 20 mg TID
[ 0 ]
1
[ 0 ]
intervention 1: sildenafil citrate (UK-92,480)
intervention 1: sildenafil citrate (UK-92,480)
8
Chiba | Chiba | Japan | 140.11667 | 35.6 Kanazawa | Ishikawa-ken | Japan | 136.61667 | 36.6 Tsu | Mie-ken | Japan | 136.51667 | 34.73333 Okayama | Okayama-ken | Japan | 133.93333 | 34.65 Hamamatsu | Shizuoka | Japan | 137.73333 | 34.7 Bunkyo-ku | Tokyo | Japan | N/A | N/A Shinjuku-ku | Tokyo | Japan | N/A | N/A Tokyo |...
0
NCT00454207
[ 5 ]
15
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension
null
Open-angle Glaucoma Ocular Hypertension
null
1
arm 1: brimonidine 0.1%
[ 0 ]
1
[ 0 ]
intervention 1: Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
intervention 1: brimonidine 0.1% (Alphagan® P)
1
San Diego | California | United States | -117.16472 | 32.71571
0
NCT00457795
[ 4 ]
323
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.
null
Chronic Pain
Breakthrough pain Opioid-tolerant Chronic pain
null
2
arm 1: This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order). arm 2: This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomi...
[ 0, 1 ]
1
[ 0 ]
intervention 1: Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment pe...
intervention 1: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
45
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Beverly Hills | California...
0
NCT00463047
[ 3 ]
7
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to determine whether the combination of bevacizumab and bortezomib have increased efficacy in the treatment of relapsed/ refractory multiple myeloma.
Rationale: With the identification of thalidomide as an active agent in Multiple Myeloma, the role of angiogenesis in its pathogenesis has become a subject of much investigation. Micro vessel density (neovascularization) is inversely related to prognosis in Multiple Myeloma. Response to thalidomide was felt to correlat...
Multiple Myeloma
multiple myeloma myeloma relapsed myeloma refractory myeloma relapsed, refractory myeloma relapsed, refractory multiple myeloma refractory multiple myeloma relapsed multiple myeloma B lymphoid malignancies Myeloma, Plasma-Cell Myeloma Proteins hnRNP A1 myeloma helix-destabilizing protein, mouse IgC3kappa Jir protein, h...
null
1
arm 1: Bortezomib will be administered at 1.3 mglm2 IVP on Days 1. 4, 8, and 11. Response will be assessed subsequent to each cycle. A total of 8 cycles would beplanned. Patients would be removed subsequent to Cycle 2. if progression of disease is documented.
[ 0 ]
1
[ 0 ]
intervention 1: Bortezomib will be administered at 1.3 mglm2 IVP on Days 1. 4, 8, and 11. Response will be assessed subsequent to each cycle. A total of 8 cycles would beplanned. Patients would be removed subsequent to Cycle 2. if progression of disease is documented.
intervention 1: Bortezomib
1
Hackensack | New Jersey | United States | -74.04347 | 40.88593
0
NCT00464178
[ 5 ]
334
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The primary purpose of this trial is to determine if the treatment with rosuvastatin 10 and 20mg/day during 8 weeks in hypertriglyceridemic patients will reduce their triglyceride levels.
null
Hypertriglyceridemia Hyperlipoproteinemia Type IV Hyperlipoproteinemia Type V Hyperlipoproteinemia Type IIb Hyperlipidemia
Triglycerides hypertriglyceridemia statins rosuvastatin hyperlipoproteinemia Fredrickson Type IIb or IV
null
0
null
null
1
[ 0 ]
intervention 1: 10mg or 20mg
intervention 1: rosuvastatin
3
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738 Mexico City | Mexico City | Mexico | -99.12766 | 19.42847 Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
0
NCT00473655
[ 4 ]
1,700
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
true
1FEMALE
false
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
null
Contraception
Contraception
null
1
arm 1: 1 tablet per day
[ 0 ]
1
[ 0 ]
intervention 1: 1 tablet per day
intervention 1: Norethindrone/ethinyl estradiol
63
Chandler | Arizona | United States | -111.84125 | 33.30616 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tempe | Arizona | United States | -111.90931 | 33.41477 Tucson | Arizona | United State...
0
NCT00477633
[ 4 ]
399
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.
null
Epilepsy
Epilepsy Brivaracetam Partial Onset Seizures
null
4
arm 1: Matching Placebo tablets administered twice a day arm 2: Brivaracetam 20 mg/day, 10 mg administered twice a day arm 3: Brivaracetam 50 mg/day, 25 mg administered twice a day arm 4: Brivaracetam 100 mg/day, 50 mg administered twice a day
[ 2, 0, 0, 0 ]
4
[ 10, 0, 0, 0 ]
intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period intervention 3: Da...
intervention 1: Placebo intervention 2: Brivaracetam intervention 3: Brivaracetam intervention 4: Brivaracetam
76
Ghent | N/A | Belgium | 3.71667 | 51.05 La Louvière | N/A | Belgium | 4.18785 | 50.48657 Liège | N/A | Belgium | 5.56749 | 50.63373 Sankt Vith | N/A | Belgium | 6.12724 | 50.28146 Kuopio | N/A | Finland | 27.67703 | 62.89238 Oulu | N/A | Finland | 25.46816 | 65.01236 Seinäjoki | N/A | Finland | 22.82822 | 62.79446 Tamp...
0
NCT00490035
[ 4 ]
804
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A study to compare the safety and efficacy of moxifloxacin to ertapenem in patients with intra-abdominal infections.
null
Infection
Complicated Intra-Abdominal Infections
null
2
arm 1: Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours. arm 2: Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Moxifloxacin, 400mg, administered intravenously once daily intervention 2: Active treatment: Ertapenem 1.0g, administered intravenously once daily
intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Ertapenem intravenous
52
Ciudadela | Buenos Aires | Argentina | -58.53941 | -34.63787 De Febrero 3 | Buenos Aires | Argentina | N/A | N/A Merlo | Buenos Aires | Argentina | -58.72744 | -34.66536 San Juan Bautista | Buenos Aires | Argentina | -58.27623 | -34.80896 Buenos Aires | Ciudad Auton. de Buenos Aires | Argentina | -58.37723 | -34.61315 ...
0
NCT00492726
[ 4 ]
163
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in the symptomatic treatment of adolescents aged 13-17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The eval...
ADHD
null
1
arm 1: Methylphenidate Transdermal System
[ 0 ]
1
[ 0 ]
intervention 1: One of 4 doses of the MTS transdermal patch over the same duration of wear for approximately 6 months
intervention 1: Methylphenidate Transdermal System
32
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Lafayette | California | United States | -122.11802 | 37.88576 Wildomar | California | United States | -117.28004 | 33.59891 Gainsville | Florida | United States | N/A | N/A South Miami | Florida | United States | -80.29338 | 25.7076 Roswell | Georgia | Unite...
0
NCT00501293
[ 5 ]
445
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults. A gatekeeper strategy will be employed for sequentially testing the secondary objectives. This study also has an observational community...
null
Attention Deficit Hyperactivity Disorder
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks intervention 2: twice a day, by mouth for 12 weeks
intervention 1: Atomoxetine hydrochloride intervention 2: Placebo
29
Los Angeles | California | United States | -118.24368 | 34.05223 Rolling Hills Est. | California | United States | N/A | N/A Spring Valley | California | United States | -116.99892 | 32.74477 Wildomar | California | United States | -117.28004 | 33.59891 Gainesville | Florida | United States | -82.32483 | 29.65163 Jacks...
0
NCT00510276
[ 3 ]
17
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 ...
null
Non-Squamous Non-Small Cell Lung Cancer
null
2
arm 1: Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles. arm 2: Participants received Gemcitabine 1000 (mg/m\^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 150 mg po daily intervention 2: As prescribed
intervention 1: Erlotinib intervention 2: Gemcitabine
14
Auchenflower | N/A | Australia | 152.99213 | -27.47443 Chermside | N/A | Australia | 153.03062 | -27.38472 Footscray | N/A | Australia | 144.9 | -37.8 Greenslopes | N/A | Australia | 153.04951 | -27.50815 Lismore | N/A | Australia | 153.2773 | -28.81354 Melbourne | N/A | Australia | 144.96332 | -37.814 Melbourne | N/A ...
0
NCT00518011
[ 3 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
A phase 2 randomized, placebo-controlled, double-blind trial of a two week course of curcuminoids in oral lichen planus will be conducted. 26 consecutive, eligible patients with OLP presenting to the oral medicine clinic at the University of California, San Francisco, will be enrolled. Study subjects will be randomized...
null
Oral Lichen Planus
curcuminoids oral lichen planus c reactive protein interleukin 6
null
2
arm 1: Curcumin C3 Complex arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Curcuminoids tablets 2000mg three times per day for 12 days intervention 2: None
intervention 1: Curcuminoids intervention 2: Placebo
1
San Francisco | California | United States | -122.41942 | 37.77493
0
NCT00525421
[ 0 ]
25
RANDOMIZED
PARALLEL
9OTHER
0NONE
true
0ALL
false
Inflammation clearly contributes to the progression of the cystic fibrosis (CF) lung disease, and administration of the anti-inflammatory agent high-dose ibuprofen retards the rate of decline of pulmonary function. However, utilization of this valuable drug has been suboptimal because of its rare, but dramatic, adverse...
The entire study period for each subject will be 15 days, and consist of 3 periods defined as: Baseline (Day 1,2,3), Treatment (Day 3-10), and Recovery (Day 13-15). Healthy volunteers will be screened on Day 1 (and assessed for eligibility); Eligible subjects will be divided into 3 drug treatment groups pioglitazone, s...
Cystic Fibrosis
healthy volunteers neutrophil migration anti inflammatory non-steroidal agent simvastatin pioglitazone
null
3
arm 1: Pioglitazone arm 2: Simvastatin arm 3: Ibuprofen 1000-16-- mg/day, maximum 3200 mg/day
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 30 mg once a day intervention 2: 40 mg once a day intervention 3: Ibuprofen 15-23 mg/kg twice daily, maximum 3200 mg/day
intervention 1: Pioglitazone intervention 2: Simvastatin intervention 3: Ibuprofen
2
Cleveland | Ohio | United States | -81.69541 | 41.4995 Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00531882
[ 5 ]
121
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.
Patients with schizophrenia or schizoaffective disorder commonly have other conditions that may affect the liver, such as alcohol abuse and/or chronic liver infections (hepatitis). Although single-dose studies in patients with liver disease are conducted to test the safety of medications, there is less information abou...
Schizophrenia Schizoaffective Disorder Psychotic Disorders
antipsychotic paliperidone ER liver disease Schizophrenia Schizoaffective Disorder Invega
null
1
arm 1: Treatment as usual (TAU), Paliperidone ERTreatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
[ 0 ]
1
[ 0 ]
intervention 1: Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
intervention 1: Treatment as usual (TAU), Paliperidone ER
21
Cerritos | California | United States | -118.06479 | 33.85835 Chino | California | United States | -117.68894 | 34.01223 Garden Grove | California | United States | -117.94145 | 33.77391 Huntington Beach | California | United States | -117.99923 | 33.6603 Santa Ana | California | United States | -117.86783 | 33.74557 T...
0
NCT00535145
[ 3 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
RATIONALE: Monoclonal antibodies such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to ...
OBJECTIVES: Primary * Determine the response rate in patients with metastatic colorectal cancer treated with cetuximab and capecitabine that progressed on prior fluoropyrimidine-containing therapy comprising irinotecan with or without oxaliplatin. Secondary * To determine the progression-free survival and overall s...
Colorectal Cancer
recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer
null
1
arm 1: Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
[ 0 ]
7
[ 2, 0, 6, 6, 6, 6, 10 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None
intervention 1: cetuximab intervention 2: capecitabine intervention 3: gene expression analysis intervention 4: microarray analysis intervention 5: polymorphism analysis intervention 6: reverse transcriptase-polymerase chain reaction intervention 7: immunohistochemistry staining method
2
Duarte | California | United States | -117.97729 | 34.13945 Pasadena | California | United States | -118.14452 | 34.14778
0
NCT00538291
[ 0 ]
25
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the cha...
The functional changes of the retina can be recorded by an electroretinography (ERG).
Age-related Macular Degeneration
age-related macular degeneration (AMD) choroidal neovascularization membrane(CNVM) ranibizumab anti-vascular endothelial growth factor electrophysiology electroretinography
null
0
null
null
1
[ 0 ]
intervention 1: A single dose of 0.5 mg ranibizumab injected intravitreally.
intervention 1: ranibizumab
1
Hat Yai | Changwat Songkhla | Thailand | 100.47668 | 7.00836
0
NCT00539734
[ 4 ]
343
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric...
null
Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago
gastrointestinal GI NSAID Japan Japanese Gastric ulcer duodenal ulcer
null
2
arm 1: Placebo arm 2: Esomeprazole 20 mg
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 20mg once daily oral intervention 2: once daily oral
intervention 1: Esomeprazole intervention 2: Placebo
39
Chiryū | Aichi-ken | Japan | 137.03333 | 35.0 Seto | Aichi-ken | Japan | 137.1 | 35.23333 Yotukaido | Chiba | Japan | N/A | N/A Miyaodai | Fukuoka | Japan | 130.71276 | 33.84661 Sapporo | Hokkaido | Japan | 141.35 | 43.06667 Akashi | HYOGOi | Japan | 135.00687 | 34.65524 Itami | Hyōgo | Japan | 135.40126 | 34.78427 Kot...
0
NCT00542789
[ 4 ]
52
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day if diuretic effect is insufficient (treatment period 2) in congestive heart failure (CHF) pa...
null
Cardiac Edema
Vasopressin antagonist , Cardiac Edema ,Diuretics
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 15-30mg/day,daily for 14days
intervention 1: OPC-41061 (Tolvaptan)
6
Chubu Region | N/A | Japan | N/A | N/A Hokkaido Region | N/A | Japan | N/A | N/A Kanto Region | N/A | Japan | N/A | N/A Kinki Region | N/A | Japan | N/A | N/A Kyuush | N/A | Japan | N/A | N/A Shikoku Region | N/A | Japan | N/A | N/A
0
NCT00544869
[ 4 ]
947
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
null
To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.
null
Overactive Bladder Syndrome
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Fesoterodine 4mg or 8mg intervention 2: Placebo
intervention 1: Fesoterodine intervention 2: Placebo
137
Birmingham | Alabama | United States | -86.80249 | 33.52066 Gilbert | Arizona | United States | -111.78903 | 33.35283 Gilbert | Arizona | United States | -111.78903 | 33.35283 Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Mesa | Arizona | United States | -111.82264 | 33.42227 Phoenix | Arizona | Uni...
0
NCT00546637
[ 5 ]
551
null
PARALLEL
0TREATMENT
null
false
0ALL
null
German stroke units are hesitating to use Aggrenox for secondary ischaemic stroke / transient ischaemic attack (TIA) prevention in a sub-acute treatment setting. They argue that clinical experience with sub-acute Aggrenox treatment is limited and poorly documented when compared with sub-acute acetylsalicylic acid (ASA)...
null
Cerebrovascular Accident
null
0
null
null
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) intervention 2: ASA 100 mg qd
1
Bad Homburg | N/A | Germany | 8.61816 | 50.22683
0
NCT00562588
[ 0 ]
71
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
1FEMALE
false
Many women choose Depo-Provera for birth control because it is easy to use and very effective. However, a significant number of Depo-Provera users experience irregular bleeding during the first 90 days. Many users discontinue after their first injection due to irregular bleeding. This study will evaluate the effect of ...
Many women choose depot medroxyprogesterone acetate (DMPA) for contraception because it is long-acting, highly effective, and requires minimal user involvement. One of the most common side effects of DMPA use during the first 90 day cycle is irregular bleeding. There are few studies that report mean number of bleeding ...
Metrorrhagia
Depo-Provera Medroxyprogesterone Acetate Metrorrhagia Irregular Bleeding
null
2
arm 1: Subjects will receive an estrogen vaginal ring (100 mcg) during the first 90 days of Depo-Provera use. arm 2: Subjects will receive Depo-Provera intramuscular injection.
[ 0, 5 ]
2
[ 0, 0 ]
intervention 1: Estrogen vaginal ring (100 mcg) placed for the first 90 days of Depo-Provera use. Femring® (estradiol acetate vaginal ring) is a flexible off-white ring designed for vaginal insertion with measurements that include an outer diameter of 56 mm, cross-sectional diameter of 7.6 mm, and core diameter of 2 m...
intervention 1: Femring® intervention 2: DepoProvera ®
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00563576
[ 3 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substa...
OBJECTIVES: Primary * To determine the safety and efficacy, as determined by response rate (complete response \[CR\] + near CR + partial response), of lenalidomide administered with rituximab in patients with relapsed and/or refractory CD20+ multiple myeloma. Secondary * To assess the effects of this regimen on pat...
Multiple Myeloma and Plasma Cell Neoplasm
refractory multiple myeloma
null
1
arm 1: This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients wi...
[ 0 ]
5
[ 2, 0, 6, 10, 10 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None
intervention 1: rituximab intervention 2: lenalidomide intervention 3: microarray analysis intervention 4: flow cytometry intervention 5: laboratory biomarker analysis
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00567229
[ 5 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
This study will evaluate the relative effectiveness of risperidone Consta injections occurring every 2 weeks in contrast to treatment as usual in preventing symptomatic relapse and rates of rehospitalization or admission into respite care for bipolar patients. Hypothesis: Risperdal Consta injections every 2 weeks will...
Bipolar disorder arguably represents the most difficult to treat of all psychiatric disorders. In fact, long-term stabilization is more the exception than the rule, and the majority of patients experience frequent relapses of illness. Studies have shown that both bipolar I and II patients spend about half of their week...
Bipolar Disorder
Bipolar Disorder Depression, Bipolar Mania
null
2
arm 1: Risperdal Consta injection in conjunction with existing treatment arm 2: Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular (IM) gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At...
intervention 1: Risperdal (risperidone) Consta intervention 2: Treatment as usual
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
0
NCT00571688
[ 5 ]
13
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.
null
Osteoporosis
null
2
arm 1: one 150 mg risedronate once a month, orally arm 2: Placebo tablet once a month, orally
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: oral tablet once a month for 12 months intervention 2: tablet, 150 mg once a month for 12 months
intervention 1: placebo intervention 2: risedronate
4
Tuscon | Arizona | United States | N/A | N/A Omaha | Nebraska | United States | -95.94043 | 41.25626 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
0
NCT00577395
[ 0 ]
44
RANDOMIZED
PARALLEL
null
3TRIPLE
false
0ALL
true
Subjects participating in this protocol will participate in three phases: 1) pre-admission, 2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in inclusion/exclusion criteria section) and one week of outpatient sleep and activity monitoring. Inpatient admission is 16 consecutive nights...
A relatively new treatment for the excessive daytime sleepiness (EDS) associated with inadequate sleep is the drug modafinil. Modafinil decreases subjective reports and objective measures of daytime sleepiness under conditions of sleep restriction, while enhancing cognitive performance. At the same time, sleep quality ...
Cocaine Dependence Substance-induced Sleep Disorder Substance-induced Cognitive Disorder
Modafinil Sleep Cognition Cocaine Dependence
null
2
arm 1: Modafinil 400mg orally everyday for 16 days arm 2: Placebo orally everyday for 16 days
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Modafinil 400mg orally every day for 16 days intervention 2: Placebo orally everyday for 16 days
intervention 1: Modafinil intervention 2: Placebo
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
0
NCT00582491
[ 3 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.
null
Osteosarcoma
Cisplatin Doxorubicin Methotrexate Osteosarcoma 03-074
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Cisplatin 120 mg/m\^2 intervention 2: 75mg/m\^2 intervention 3: Methotrexate 12g/m\^2
intervention 1: Cisplatin intervention 2: Doxorubicin intervention 3: Methotrexate
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00586846
[ 0 ]
26
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
This was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was that clonidine will be as effective as steroid for this condition.
Patients with approximately 3 months of low back pain and leg pain due to intervertebral disc herniation were randomized to transforaminal epidural injections of 2% lidocaine and either clonidine (200 or 400 micrograms) or triamcinolone (40 mg) (corticosteroid). Patients received one to three injections administered at...
Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
herniated disk radiculopathy clonidine epidural steroid corticosteroid nucleus pulposus transforaminal
null
2
arm 1: Transforaminal epidural clonidine injection arm 2: Transforaminal epidural steroid injection
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 200 or 400 micrograms clonidine intervention 2: 40 or 80 milligrams triamcinolone intervention 3: 1 ml 2% lidocaine (20 mg/mL)
intervention 1: Clonidine intervention 2: Triamcinolone hexacetonide intervention 3: Lidocaine HCl
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
0
NCT00588354
[ 5 ]
157
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
1FEMALE
false
This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or plac...
null
Nocturnal Vasomotor Symptoms
Nocturnal vasomotor symptoms in postmenopausal women
null
3
arm 1: 0.3 mg SCE-B Daily arm 2: 0.625 mg SCE-B Daily arm 3: Placebo
[ 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: 0.3 mg or 0.625 mg SCE-B tablets daily plus matching placebo intervention 2: Matching placebo for 0.3 mg and 0.625 mg tablets
intervention 1: SCE-B intervention 2: Placebo
17
Anaheim | California | United States | -117.9145 | 33.83529 Sacramento | California | United States | -121.4944 | 38.58157 San Diego | California | United States | -117.16472 | 32.71571 Clearwater | Florida | United States | -82.8001 | 27.96585 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Lexington ...
0
NCT00592839
[ 3 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
As a consequence of damage to multiple organ systems throughout the course of their disease, diabetic patients suffer a number of chronic complications giving rise to increased morbidity, mortality, and health care costs specific to this population. Within the ophthalmic domain, diabetic retinopathy (DR) frequently ind...
In individuals with certain clinical conditions, such as diabetes, corneal epithelial defects persist and do not necessarily respond to conventional treatment regimens because of delayed epithelial wound healing. While wound closure should occur following an injury to the corneal epithelium, a timely re-establishment o...
Diabetes
Thymosin beta 4 Corneal wound healing Vitrectomy Diabetes
null
2
arm 1: There are 2 groups: active drug and placebo. The patients in the placebo arm receive an administration of eyedrops to the affected eye, identical to the active drug but with no thymosin beta 4 (0.00% thymosin beta 4, w/w), 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 ...
[ 2, 1 ]
2
[ 0, 10 ]
intervention 1: There are 2 groups: active drug and placebo. The patients in the active arm receive an administration of 0.01% Tβ4 (w/w) eyedrops to the affected eye, 2 drops 4 times daily (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy)...
intervention 1: Thymosin Beta 4 (Tβ4) intervention 2: Placebo
5
Inglewood | California | United States | -118.35313 | 33.96168 Los Angeles | California | United States | -118.24368 | 34.05223 Orlando | Florida | United States | -81.37924 | 28.53834 Augusta | Georgia | United States | -81.97484 | 33.47097 Asheville | North Carolina | United States | -82.55402 | 35.60095
0
NCT00598871
[ 3 ]
166
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a plac...
The rationale of this study is to combine two distinct kinase inhibitors to evaluate synergistic inhibition of angiogenesis and epidermal growth factor receptor (EGFR) signaling. Erlotinib is a oral tyrosine kinase inhibitor that targets EGFR. Sorafenib is a oral tyrosine kinase inhibitor targeting vascular endothelial...
Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer Advanced Sorafenib Erlotinib Double-blind Placebo-controlled
null
2
arm 1: Erlotinib + Sorafenib arm 2: Erlotinib + Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day. intervention 2: Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.
intervention 1: Erlotinib + Sorafenib intervention 2: Erlotinib + Placebo
16
Fort Myers | Florida | United States | -81.84059 | 26.62168 Gainesville | Georgia | United States | -83.82407 | 34.29788 Marietta | Georgia | United States | -84.54993 | 33.9526 Overland Park | Kansas | United States | -94.67079 | 38.98223 Bethesda | Maryland | United States | -77.10026 | 38.98067 Grand Rapids | Michig...
0
NCT00600015
[ 3 ]
40
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
true
1FEMALE
false
The ultimate aim of this study is to test the hypothesis that the oral cholecystokinin (CCK) agonist GSKI181771X will reduce the size of a binge meal among individuals with Bulimia Nervosa. The study will be conducted in phases. First, an effective dose for reducing food intake, when normal subjects eat normally will b...
This study tests the hypothesis that an oral CCK antagonist GSKI181771X will reduce the size of a binge meal. It was intended to study the effects of increasing doses on antagonist on normal individuals to find an effective dose in a non-binge meal before moving to a binge meal. Once the effects of the antagonist on a ...
Bulimia
Eating Food Intake Appetite
null
8
arm 1: 'Instructions to eat normally' Placebo 1 mg dose arm 2: 'Instructions to eat normally' drug 1 mg dose 'GSKI181771X (CCK-1R agonist)' arm 3: 'Instructions to eat normally' 2 mg placebo arm 4: 'Instructions to eat normally' 2 mg drug 'GSKI181771X (CCK-1R agonist)' arm 5: 'Instructions to eat normally' 4 mg placebo...
[ 2, 1, 2, 1, 2, 1, 2, 1 ]
4
[ 0, 5, 5, 0 ]
intervention 1: Drug one trial vs placebo intervention 2: Subjects will be instructed to binge eat and will also be given either drug or placebo intervention 3: Subjects will be instructed to eat normally and will also be given either drug or placebo intervention 4: Drug one trial vs placebo
intervention 1: GSKI181771X (CCK-1R agonist) intervention 2: Instructions to binge eat intervention 3: Instructions to eat normally intervention 4: Placebo
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00600743
[ 4 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this t...
null
Chronic Hepatitis B
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks intervention 2: Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
intervention 1: Entecavir + Tenofovir intervention 2: Adefovir + continuing Lamivudine
29
Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 Chicago | Illinois | United States | -87.65005 | 41.85003 New York | New York | United States | -74.00597 | 40.71427 Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | ...
0
NCT00605384
[ 0 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
To evaluate galantamine's effects on cognitive performance in abstinent cocaine users. Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these effects may result in improved cognitive perform...
Galantamine, compared to placebo, will improve cognitive performance in abstinent cocaine users. The cognitive performance will be measured with the Stroop test and 3 Cambridge Neuropsychological Test Automated Battery (CANTAB) tests: Paired Associate Learning (PAL), Delayed Pattern Recognition Memory (PRM),and Rapid V...
Cocaine Abuse
cognitive enhancers Nootropic Agents
null
2
arm 1: Galantamine 8 mg/day arm 2: placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Galantamine 8 mg/day intervention 2: sugar pill
intervention 1: Galantamine intervention 2: placebo
1
West Haven | Connecticut | United States | -72.94705 | 41.27065
0
NCT00606801
[ 5 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis. It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used...
LMB (localized mild breakthrough)is one of two psoriasis adverse events commonly seen in efalizumab treated patients. It is generally papular in nature and does not involve existing lesions. Clinical experience suggests that LMB may not have a clinical impact in patients responding to efalizumab and therefore may be tr...
Plaque Psoriasis
Localized mild breakthrough
null
0
null
null
1
[ 0 ]
intervention 1: One application to affected areas, once a day for two weeks. The PI may choose to extend treatment until Week 4 if necessary.
intervention 1: Calcipotriene/betamethasone
1
Louisville | Kentucky | United States | -85.75941 | 38.25424
0
NCT00608777
[ 4 ]
929
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes
null
Diabetes Diabetes Mellitus, Type 2
null
4
arm 1: Liraglutide 0.6 mg + metformin + glimepiride placebo arm 2: Liraglutide 1.2 mg + metformin + glimepiride placebo arm 3: Liraglutide + metformin + glimepiride placebo arm 4: Glimepiride 4.0 mg + metformin + liraglutide placebo
[ 0, 0, 0, 0 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: 0.6 mg/day, s.c. (under the skin) injection intervention 2: Glimepiride placebo, capsules intervention 3: 1.2 mg/day, s.c. (under the skin) injection intervention 4: 1.8 mg/day, s.c. (under the skin) injection intervention 5: Capsules, 4.0 mg/day intervention 6: Tablets, 1.5-2.0 g/day intervention 7: Li...
intervention 1: liraglutide intervention 2: placebo intervention 3: liraglutide intervention 4: liraglutide intervention 5: glimepiride intervention 6: metformin intervention 7: placebo
50
Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Chongqing | Chongqing Municipality | China | 106.55771 | 29.56026 Fuzhou | Fujian | China | 119.30611 | 26.06139 Harbin | Heilongjiang | China | 126.65 | 45.75 Harbin | Heilongjiang | China | 126.65...
0
NCT00614120
[ 5 ]
6
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.
The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The decision to terminate the trial was not based on any safety concerns. Patients who were enrolled in the study prior to January 12, 2009 were allowed to remain in the study until completing their participation as specified in the...
Aspergillosis
invasive aspergillosis, opportunistic mold infection
null
2
arm 1: anidulafungin plus voriconazole arm 2: anidulafungin plus voriconazole
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance \<50 ml/min will ...
intervention 1: voriconazole intervention 2: anidulafungin
4
Atlanta | Georgia | United States | -84.38798 | 33.749 Detroit | Michigan | United States | -83.04575 | 42.33143 Fort Worth | Texas | United States | -97.32085 | 32.72541 Fort Worth | Texas | United States | -97.32085 | 32.72541
0
NCT00620074
[ 4 ]
108
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
true
1FEMALE
false
The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.
null
Contraception
null
2
arm 1: The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. arm 2: Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispe...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Radiopaque rod for 3 years intervention 2: Implanon (etonogestrel implant) for 3 years
intervention 1: Radiopaque Implanon intervention 2: Implanon (etonogestrel implant)
0
null
0
NCT00620464
[ 0 ]
87
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Cardiopulmonary bypass \[CPB\] in small size bodies can result in decreased peripheral perfusion. This results in anaerobic metabolism as evidenced by lactic acidosis. High flow perfusion results in systemic hypertension which is accentuated by moderate hypothermia commonly used during cardiopulmonary bypass. Phenoxybe...
Background Cardiopulmonary bypass \[CPB\] in small size bodies can result in decreased peripheral perfusion. This results in anaerobic metabolism as evidenced by lactic acidosis. High flow results in systemic hypertension which is accentuated by moderate hypothermia commonly used during cardiopulmonary bypass. Phenoxyb...
Congenital Heart Surgery Cardiopulmonary Bypass
Congenital heart surgery Cardiopulmonary bypass Phenoxybenzamine
null
1
arm 1: Treatment Group
[ 0 ]
1
[ 0 ]
intervention 1: Use of Phenoxybenzamine: Loading dose given at the time of going on CPB: * For patients with obstructing lesions on systemic side: * 0.25 mg/kg dose in the bypass circuit * None intravenous * For patients without obstructing left sided lesions: * 0.5 mg/kg in the bypass circuit * 0.5 mg/kg I...
intervention 1: Phenoxybenzamine
0
null
0
NCT00620945
[ 3 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.
null
Hepatitis C
Chronic Hepatitis C Protease Inhibitor
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)
intervention 1: MP-424 (Telaprevir)
1
Kawasaki | Takatsu-ku | Japan | 139.71722 | 35.52056
0
NCT00621296
[ 3 ]
45
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
null
This study will assess the safety, tolerability, and pharmacodynamics of CK-1827452 infusion in patients with stable heart failure.
null
Heart Failure
null
5
arm 1: 4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. arm 2: 4 treatment periods with a 2 hour infusion. The 4 treatment periods con...
[ 0, 0, 0, 0, 0 ]
16
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: IV infusion for 1 hour at 0.125 mg/kg/h followed by 1 hour at 0.0625 mg/kg/h intervention 2: IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h intervention 3: IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h intervention 4: IV infusion for 1 hour at 0.75 ...
intervention 1: CK-1827452 intervention 2: CK-1827452 intervention 3: CK-1827452 intervention 4: CK-1827452 intervention 5: CK-1827452 intervention 6: CK-1827452 intervention 7: CK-1827452 intervention 8: CK-1827452 intervention 9: Placebo intervention 10: Placebo intervention 11: CK-1827452 intervention 12: Placebo in...
17
San Diego | California | United States | -117.16472 | 32.71571 Newark | Delaware | United States | -75.74966 | 39.68372 Tbilisi | N/A | Georgia | 44.83412 | 41.69143 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 Sa...
0
NCT00624442
[ 5 ]
3
RANDOMIZED
SINGLE_GROUP
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a prospective, randomized, double-blinded, placebo controlled pilot safety study that will enroll a total of twenty subjects. Subjects will be adults (30-75) who have sustained a SAH secondary to cerebral aneurysm rupture and who present with minimal neurological symptoms. All subjects will have a Hemoglobin le...
null
Subarachnoid Hemorrhage
Epoetin alfa aneurysm subarachnoid hemorrhage
null
2
arm 1: Group A will receive Procrit® intravenous injections (40,000U) once daily for 3 days (Study Days 1, 2, and 3). The first dose of Procrit® will be given within 36 hours of the initial SAH event / symptoms and immediately before the vascular clipping procedure. arm 2: Group B will receive Saline intravenous inject...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Intravenous administration of epoetin alfa (40,000 IU) immediately before clipping surgery. Successive doses will be given 24 and 48 hours after the first dose. intervention 2: 3ml of saline will be administered via an IV push immediately before clipping surgery. Successive doses will be given 24 and 48...
intervention 1: Epoetin alfa intervention 2: Saline
1
Tampa | Florida | United States | -82.45843 | 27.94752
0
NCT00626574
[ 5 ]
97
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.
null
Sjogren's Syndrome
Ocular inflammation
null
2
arm 1: Maxidex arm 2: Healthy normal control group receiving no treatment
[ 0, 3 ]
2
[ 0, 10 ]
intervention 1: Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily intervention 2: Healthy normal control group receiving no treatment
intervention 1: Maxidex intervention 2: No treatment
2
Toronto | N/A | Canada | -79.39864 | 43.70643 Waterloo | N/A | Canada | -80.51639 | 43.4668
0
NCT00631358
[ 3 ]
37
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
4-Week Safety Study in Subjects with Neutrophilic Asthma
Effect of treatment with navarixin (MK-7123, SCH 527123) on sputum neutrophils and asthma symptoms
Neutrophilic Asthma
null
2
arm 1: Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks arm 2: Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks. intervention 2: Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks. intervention 3: Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or...
intervention 1: Navarixin intervention 2: Placebo intervention 3: Rescue medication
0
null
0
NCT00632502
[ 2 ]
9
NA
SINGLE_GROUP
9OTHER
0NONE
false
0ALL
false
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects
Infection
PK Pharmacokinetics
null
1
arm 1: ceftaroline
[ 0 ]
1
[ 0 ]
intervention 1: Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.
intervention 1: ceftaroline
4
Louisville | Kentucky | United States | -85.75941 | 38.25424 Durham | North Carolina | United States | -78.89862 | 35.99403 Akron | Ohio | United States | -81.51901 | 41.08144 Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00633126
[ 5 ]
247
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. This study will last ...
null
Pulmonary Disease, Chronic Obstructive
DISKUS Salmeterol Fluticasone Propionate Chronic Obstructive Pulmonary Disease (COPD) Hydroflouroalkane COPD HFA MDI
null
2
arm 1: None arm 2: None
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: treatment drug intervention 2: treatment drug
intervention 1: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg intervention 2: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg
16
Jasper | Alabama | United States | -87.27751 | 33.83122 Mobile | Alabama | United States | -88.04305 | 30.69436 Lafayette | Louisiana | United States | -92.01984 | 30.22409 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Sunset | Louisiana | United States | -92.06845 | 30.41131 Saint Charles | Missouri |...
0
NCT00633217
[ 3, 4 ]
124
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma, based on asthma medication use during a period of 2 months with a high environmental exposure to mites (autumn 2008).
This trial was conducted as a multi-centre, randomised, double-blind, parallel-group, placebo-controlled phase III trial, assessing the efficacy of SLITone Dermatophagoides mix in adults (18-65 years). 5 centres in Spain participated. Subjects with house dust mite allergic asthma were randomised to receive either SLIT...
Allergy
House dust mites Sublingual immunotherapy Allergy Allergic asthma
null
2
arm 1: SLITone Dermatophagoides Mix arm 2: SLITone Placebo
[ 1, 2 ]
7
[ 2, 2, 0, 0, 0, 0, 0 ]
intervention 1: Sublingual immunotherapy with SLITone Dermatophagoides mix (200 STU) once daily for 2 years intervention 2: Sublingual immunotherapy once daily for 2 years intervention 3: 200 µg per puff; a short acting beta2-agonist (please refer to the 'detailed description' for details on the use) intervention 4: 80...
intervention 1: SLITone(TM) Dermatophagoides mix intervention 2: Placebo intervention 3: Salbutamol inhaler intervention 4: Budesonide/formoterol inhaler intervention 5: Prednisone tablet intervention 6: Desloratadine tablet intervention 7: Budesonide nasal spray
1
Santander | Cantabria | Spain | -3.80444 | 43.46472
0
NCT00633919
[ 5 ]
6
RANDOMIZED
PARALLEL
9OTHER
3TRIPLE
true
0ALL
false
This study examines the effects of an antidepressant medication and placebo on the brain functioning of normal subjects. In this study, recordings of brain electrical activity are being used to detect and monitor the response to treatment with venlafaxine IR (Effexor), a drug used for the treatment of depression. The i...
Major Depressive Disorder (MDD) is a lifelong and recurrent illness, such that many individuals require multiple courses of antidepressant medication treatment. While some patients respond completely to each course of treatment, many do not, and with each unsuccessful antidepressant trial the likelihood that a patient ...
Depression
null
2
arm 1: Subjects who had previously been exposed to active antidepressant medication (venlafaxine) arm 2: Subjects who had previously been exposed to placebo only (and never to active antidepressant medication)
[ 0, 2 ]
1
[ 0 ]
intervention 1: venlafaxine IR 150mg
intervention 1: venlafaxine
1
Los Angeles | California | United States | -118.24368 | 34.05223
0
NCT00634283