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detailedDescription
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numArms
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[ 3 ]
29
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Primary Objective: To evaluate efficacy and safety of ITF2357 in the treatment of patients with JAK2V617F positive myeloproliferative diseases \[Polycythemia Vera (PV), Essential Thrombocytosis (ET), Myelofibrosis (MF)\]. Efficacy was evaluated by ad hoc haematological and clinical criteria for PV and ET, and by inter...
This is a non-randomized, open-label, Phase IIA pilot study testing efficacy and safety of ITF2357 in a population of patients with JAK2V617F positive myeloproliferative diseases. All recruited patients received an initial dose of 50 mg b.i.d. of ITF2357 that was subsequently escalated to 50 mg t.i.d. in case of lack o...
Myeloproliferative Diseases
polycythemia vera (PV) essential thrombocythemia (ET) myelofibrosis (MF)
null
1
arm 1: Initial dose of 50 mg b.i.d. that was subsequently escalated to 50 mg t.i.d in case of lack of significant toxicity.
[ 0 ]
1
[ 0 ]
intervention 1: 50 mg b.i.d. PO every day. More precisely, ITF2357 was supplied as 50 mg hard gelatine capsules for oral administration.
intervention 1: ITF2357
2
Bergamo | N/A | Italy | 9.66721 | 45.69601 Pavia | N/A | Italy | 9.15917 | 45.19205
0
NCT00606307
[ 5 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
We are trying to learn if small changes in the amount of a valproate in the blood (given through an IV) will change the way the brain reacts to flashing lights.
Photosensitive epilepsy is a form of epilepsy that is considered to have a genetic basis in most instances. It is a reflex type of epilepsy. Patients with this condition exhibit epileptic activity patterns (called photoparoxysmal response-PPR) on their EEG during intermittent photic stimulation with certain flash frequ...
Photosensitive Epilepsy
epilepsy photosensitive valproic acid
null
1
arm 1: all patients will have placebo on day 1 and VPA infusion on day 2
[ 0 ]
2
[ 0, 0 ]
intervention 1: The investigators will utilize intravenous sodium valproate at visit 3. Dosage will be individualized to each patient's body weight, age, and hepatic-enzyme-inducing status. Intravenous VPA dose predictions will be based upon population VPA pharmacokinetic parameters (Dutta 2003). intervention 2: Each p...
intervention 1: Valproic Acid intervention 2: Placebo
2
Chesterfield | Missouri | United States | -90.57707 | 38.66311 Nashville | Tennessee | United States | -86.78444 | 36.16589
0
NCT00609245
[ 3 ]
17
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6 months. To aggressively treat this cancer this study uses effective drugs in three parts: * Induction ends on day 19 * Consolidation ends ...
null
Non-Hodgkin's Lymphoma
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: LSA4 intervention includes three phases: induction, consolidation and maintenance
intervention 1: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00610883
[ 3 ]
48
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may k...
OBJECTIVES: Primary * To determine the rate of clinical benefit (complete response \[CR\], partial response \[PR\], and stable disease \[SD\] in patients with hormone-dependent locally recurrent or metastatic breast cancer treated with letrozole in combination with erlotinib hydrochloride. Secondary * To determine ...
Breast Cancer
recurrent breast cancer stage IV breast cancer
null
2
arm 1: None arm 2: None
[ 0, 0 ]
5
[ 0, 0, 6, 10, 10 ]
intervention 1: OSI-774 150 mg/day intervention 2: Letrozole 2.5 mg/day intervention 3: To determine HER2 gene amplification or excess copies of the HER2 gene intervention 4: to measure the epidermal growth factor receptors (EGFR) intervention 5: To determine if specific biomarkers exhibit a longer time to tumor progre...
intervention 1: erlotinib hydrochloride intervention 2: letrozole intervention 3: fluorescence in situ hybridization intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis
9
Macon | Georgia | United States | -83.6324 | 32.84069 Hopkinsville | Kentucky | United States | -87.49117 | 36.86561 Paducah | Kentucky | United States | -88.60005 | 37.08339 Chattanooga | Tennessee | United States | -85.30968 | 35.04563 Germantown | Tennessee | United States | -89.81009 | 35.08676 Jackson | Tennessee ...
0
NCT00611715
[ 3 ]
257
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to ...
null
Acne Vulgaris
null
4
arm 1: Doxycycline dosed at 40 mg/day to subjects of appropriate weights arm 2: Doxycycline dosed at 80 mg/day to subjects of appropriate weights arm 3: Doxycycline dosed at 160 mg/day to subjects of appropriate weights arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: doxycycline 40 mg/day, oral, 12 weeks intervention 2: doxycycline 80 mg/day, 12 weeks intervention 3: doxycycline 160 mg/day, 12 weeks intervention 4: Placebo, 12 weeks
intervention 1: Doxycycline 0.6 mg/kg/day intervention 2: Doxycycline 1.2 mg/kg/day intervention 3: Doxycycline 2.4 mg/kg/day intervention 4: Placebo
23
Encino | California | United States | -118.50119 | 34.15917 Fremont | California | United States | -121.98857 | 37.54827 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 Denver | Colorado | United States | -104.9847 | 39.73915 Miami | Florid...
0
NCT00612573
[ 4 ]
169
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.
null
Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease, indacaterol, tiotropium, placebo controlled
null
4
arm 1: In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry...
[ 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Indacaterol 150 μg or 300 μg, delivered via SDDPI intervention 2: Tiotropium 18 μg once daily delivered via inhalation device intervention 3: Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium manufacturer's proprietary inhala...
intervention 1: Indacaterol intervention 2: Tiotropium intervention 3: Placebo
20
Camperdown | N/A | Australia | 151.17642 | -33.88965 Gauting | N/A | Germany | 11.37703 | 48.06919 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Mainz | N/A | Germany | 8.2791 | 49.98419 Marburg | N/A | Germany | 8.77069 | 50.80904 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Almelo | N/A | Netherlands | 6.6625 ...
0
NCT00615459
[ 3 ]
456
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up pe...
Generalized Anxiety Disorder
Anxiety
null
3
arm 1: SEP-225441 (eszopiclone) total daily dose of 1.5 mg arm 2: SEP-225441 (eszopiclone) total daily dose of 0.9 mg arm 3: Placebo total daily dose 0.9 mg
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: SEP-225441 (eszopiclone) total daily dose of 1.5 mg intervention 2: SEP-225441 (eszopiclone) total daily dose of 0.9 mg intervention 3: Placebo total daily dose 0.9 mg
intervention 1: eszopiclone intervention 2: eszopiclone intervention 3: Placebo
57
Birmingham | Alabama | United States | -86.80249 | 33.52066 Arcadia | California | United States | -118.03534 | 34.13973 Beverly Hills | California | United States | -118.40036 | 34.07362 Burbank | California | United States | -118.30897 | 34.18084 Glendale | California | United States | -118.25508 | 34.14251 Glendale ...
0
NCT00616655
[ 3 ]
73
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).
null
Moderate or Severe Submental Fullness
null
6
arm 1: Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments. arm 2: Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment se...
[ 0, 2, 0, 2, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL. intervention 2: None
intervention 1: Deoxycholic Acid Injection intervention 2: Placebo
7
Toorak | Victoria | Australia | 145.01438 | -37.84165 Sydney | N/A | Australia | 151.20732 | -33.86785 Niagara Falls | Ontario | Canada | -79.06627 | 43.10012 Oakville | Ontario | Canada | -79.68292 | 43.45011 Toronto | Ontario | Canada | -79.39864 | 43.70643 Toronto | Ontario | Canada | -79.39864 | 43.70643 Manchester...
0
NCT00618618
[ 4 ]
343
NON_RANDOMIZED
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compar...
Issues on safety will be addressed in Adverse Events section.
Central Nervous System Diseases
Central Nervous System Imaging Diagnostic Imaging
null
1
arm 1: Participants were administered a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) bolus administration using a power injector via a peripheral vein (an antecubital vein was preferred). Gadobutrol was injected at a rate of 2 mL/second followed by a 20-mL 0.9% saline flush at the same ...
[ 0 ]
1
[ 0 ]
intervention 1: Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.
intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
37
Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | Ca...
0
NCT00623467
[ 1 ]
12
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
false
0ALL
false
Summary: A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Therefore, the proposed st...
Subjects will be put through two study periods. Each study period will consist of four visits and will be separated by 2-4 weeks. On the first visit, subjects will undergo screening procedures, including complete history and physical examination. In addition, methacholine inhalation challenge and skin-prick testing wil...
Asthma
asthma atopy allergen challenge sputum myeloid and plasmacytoid dendritic cells
null
2
arm 1: Inhalation challenge preformed with diluent. arm 2: Inhalation challenge preformed with allergen.
[ 2, 1 ]
1
[ 0 ]
intervention 1: None
intervention 1: Aeroallergen
1
Hamilton | Ontario | Canada | -79.84963 | 43.25011
0
NCT00625989
[ 4 ]
602
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles clas...
null
Reflux Esophagitis
Reflux Esophagitis
null
3
arm 1: Esomeprazole 20mg arm 2: Esomeprazole 40mg arm 3: Omeprazole 20mg
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 20mg once daily intervention 2: 40 mg once daily intervention 3: 20mg once daily
intervention 1: Esomeprazole intervention 2: Esomeprazole intervention 3: Omeprazole
41
Akita | Akita | Japan | 140.11667 | 39.71667 Kashiwa | Chiba | Japan | 139.97732 | 35.86224 Kisarazu | Chiba | Japan | 139.93254 | 35.38329 Kōriyama | Fukishima | Japan | 140.38333 | 37.4 Nihonmatsu | Fukishima | Japan | 139.26427 | 37.96201 Nishishirakawa | Fukishima | Japan | N/A | N/A Fukuoka | Fukuoka | Japan | 130...
0
NCT00633932
[ 3 ]
261
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients wil...
null
Hypertension
Hypertension High Blood Pressure
null
5
arm 1: Irbesartan 300 mg once daily arm 2: Blinded Placebo Treatment arm 3: PS433540 200mg once daily arm 4: PS433540 400mg once daily arm 5: PS433540 800mg once daily
[ 1, 2, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 300 mg (2 x 150 mg capsules) once daily for 12 weeks intervention 2: placebo capsules once daily for 12 weeks intervention 3: 200 mg (2 x 100 mg capsules) once daily for 12 weeks intervention 4: 400 mg (4 x 100 mg capsules) once daily for 12 weeks intervention 5: 800 mg (8 x 100 mg capsules) once daily ...
intervention 1: irbesartan intervention 2: placebo intervention 3: PS433540 intervention 4: PS433540 intervention 5: PS433540
40
Pell City | Alabama | United States | -86.28609 | 33.58621 Tempe | Arizona | United States | -111.90931 | 33.41477 Tucson | Arizona | United States | -110.92648 | 32.22174 Anaheim | California | United States | -117.9145 | 33.83529 Buena Park | California | United States | -117.99812 | 33.86751 Lincoln | California | U...
0
NCT00635232
[ 5 ]
1,570
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.
Pain affects more Americans than diabetes, heart disease and cancer combined and although it is one of the earliest known ailments, pain is still without a universal cure. It is estimated that only about 25% of patients with chronic pain receive adequate analgesia. Long-term treatment of chronic pain with opioids is r...
Pain
pain opioid abuse moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.
intervention 1: morphine sulfate extended release capsules
384
Adamsville | Alabama | United States | -86.95611 | 33.60094 Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Sun City | Arizona | United States | -112.27182 | 33.59754 Sun Lakes | Arizona | United States | -111.87542 | 33.21116 Tucson | Arizona | Uni...
0
NCT00640042
[ 1 ]
20
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
Pregabalin is approved for the treatment of nerve pain as well as an additional therapy in the treatment of seizures. In December 2004, Pfizer gained Food and Drug Administration (FDA) approval for use of pregabalin in nerve pain associated with diabetes and shingles; making it the first FDA-approved treatment for both...
Overview We propose a single site, double-blind, placebo-controlled, cross-over design. Drug will be administered in 75mg capsules with a target dose of 300 mg/day. Pregabalin will be titrated upward as described in the "Summary of Schedule" table with flexibility. During weeks 3-5 and 12-14, the investigator will have...
Essential Tremor
Essential tremor Activities of Daily Living (ADL's)
null
2
arm 1: Pregabalin (Lyrica) 75 mg bid to a maximum dose of 300 mg bid arm 2: Placebo to 4 capsules bid
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 75 mg bid to 300 mg bid based on per subject tolerability intervention 2: up to 4 capsules bid as tolerated
intervention 1: pregabalin (Lyrica) intervention 2: placebo
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00646451
[ 0 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this medicine has been approved by the Food and Drug Administration to treat patients with other types of lymphomas, and has be...
null
Hodgkin's Disease Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma
RITUXIMAB Lymphoma
null
1
arm 1: Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.
[ 0 ]
1
[ 0 ]
intervention 1: Rituximab 375 mg/m\^2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is \> 200 cells/ul or a maximum of 6 doses have been given.
intervention 1: Rituximab
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00648037
[ 4 ]
29
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This pilot trial in Finland is designed to evaluate in a randomized fashion change of agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first visits on days 1, 2, 4 or 5 and 7 ± 1.
null
Schizophrenic Disorders
Schizophrenia Schizoaffective psychosis Schizophreniformic psychosis Pilot study Quetiapine Prolong Risperidone
null
2
arm 1: Oral arm 2: Oral
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Oral administration intervention 2: Oral administration
intervention 1: Quetiapine intervention 2: Risperidone
4
Harjavalta | N/A | Finland | 22.13333 | 61.31667 Helsinki | N/A | Finland | 24.93545 | 60.16952 Pitkäniemi | N/A | Finland | 23.57654 | 61.48226 Turku | N/A | Finland | 22.26869 | 60.45148
0
NCT00660595
[ 3 ]
29
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).
28 eligible subjects were planned to be enrolled to determine bioequivalence and safety parameters of two 15 U TI Inhalation Powder cartridges versus one 30 U TI Inhalation Powder cartridge, according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30 U TI Inhalation Powder cartridge to a ...
Diabetes Mellitus: Type 1
Diabetic adult male, diabetic adult female
null
3
arm 1: Technosphere® Insulin Inhalation Powder, two 15 U cartridges arm 2: Technosphere® Insulin Inhalation Powder, one 30 U cartridge arm 3: Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: TI Inhalation Powder, two 15 U cartridges intervention 2: TI Inhalation Powder, one 30 U cartridge intervention 3: RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.
intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Technosphere Insulin® Inhalation Powder intervention 3: RAA Population
2
Chula Vista | California | United States | -117.0842 | 32.64005 San Antonio | Texas | United States | -98.49363 | 29.42412
0
NCT00662857
[ 2 ]
20
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.
null
Hepatitis, Chronic Hepatitis C Virus
null
2
arm 1: None arm 2: Dose study drug in subjects who have previously failed to respond to interferon based therapies
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Study drug will be administered 700mg BID in the fed state for three days. intervention 2: Study drug will be given 450mg BID for a duration of 10 days.
intervention 1: Small Molecule Agent (PF-868554) intervention 2: Small Molecule Agent (PF-868554)
1
Gainesville | Florida | United States | -82.32483 | 29.65163
0
NCT00671671
[ 3 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.
The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks. Methyl aminolevulinate 80 mg/g cream (MAL cream 8%...
Acne Vulgaris
null
2
arm 1: PDT using MAL crem arm 2: PDT using Placebo cream
[ 0, 2 ]
1
[ 0 ]
intervention 1: Cream application followed by illumination with red light
intervention 1: Methyl aminolevulinate (MAL) PDT
2
Naperville | Illinois | United States | -88.14729 | 41.78586 Albuquerque | New Mexico | United States | -106.65114 | 35.08449
0
NCT00673933
[ 5 ]
53
RANDOMIZED
PARALLEL
9OTHER
4QUADRUPLE
false
0ALL
false
The main purposes of this study are to find out if the study drug losartan (Cozaar) or placebo ("sugar pill") has an effect on insulin sensitivity (how your body responds to insulin) and to measure the effect of the study drug losartan or placebo on how the arteries in your arm dilate (enlarge to carry more blood). We...
null
Obesity Hypertension Hyperglycemia
Impaired Fasting Glucose FPG >100-<126 mg/dL
null
2
arm 1: Losartan 100 mg 1 tab po QD arm 2: Placebo 1 tab po QD
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: losartan 100 mg tablets 1 tab po QD intervention 2: Placebo 1 po QD
intervention 1: losartan intervention 2: Placebo control
9
Little Rock | Arkansas | United States | -92.28959 | 34.74648 San Diego | California | United States | -117.16472 | 32.71571 Miami | Florida | United States | -80.19366 | 25.77427 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Boston | Massachusetts | United States | -71.05977 | 42.35843 New York | New Y...
0
NCT00675987
[ 3 ]
33
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
false
2MALE
true
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer. The effect of Polyphenon E on ...
Prostate Cancer
EGCG polyphenols biomarkers prostate specific antigen
null
1
arm 1: Single arm for a phase II study
[ 0 ]
1
[ 0 ]
intervention 1: 4 capsules daily with a meal for the duration of the study
intervention 1: Polyphenon E (EGCG)
1
Shreveport | Louisiana | United States | -93.75018 | 32.52515
0
NCT00676780
[ 5 ]
45
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
1FEMALE
false
The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-lut...
null
Premenstrual Dysphoric Disorder Premenstrual Syndrome
hormones menses PMS PMDD
null
2
arm 1: PMDD group received fluoxetine 20 mg daily by mouth for 2-3 months arm 2: None
[ 0, 4 ]
1
[ 0 ]
intervention 1: Fluoxetine 20 mg daily by mouth for 2-3 months.
intervention 1: fluoxetine
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
0
NCT00678574
[ 0 ]
21
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
1FEMALE
true
Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin relea...
null
PCOS
null
2
arm 1: PCOS subjects given diazoxide arm 2: Normal subjects given diazoxide
[ 0, 1 ]
1
[ 0 ]
intervention 1: 100mg orally three times per day for 10 days
intervention 1: diazoxide
1
Richmond | Virginia | United States | -77.46026 | 37.55376
0
NCT00683774
[ 2 ]
19
RANDOMIZED
PARALLEL
9OTHER
1SINGLE
true
0ALL
false
The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. ...
During the first study visit, as a dose-optimizing study, each subject will be randomly assigned to one of two Dose-Test arms to receive either 15mg or 30mg of nitroglycerin on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. On the second...
Healthy
To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization
null
4
arm 1: Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1 arm 2: Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1 arm 3: Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the o...
[ 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 15mg Nitroglycerin applied topically to one wrist intervention 2: 30mg Nitroglycerin applied topically to one wrist intervention 3: 20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo intervention 4: 40mg Lidocaine applied topically to one wrist in combination with...
intervention 1: Nitroglycerin 15mg intervention 2: Nitroglycerin 30mg intervention 3: Lidocaine 20mg intervention 4: Lidocaine 40mg intervention 5: Placebo
1
San Francisco | California | United States | -122.41942 | 37.77493
0
NCT00686231
[ 4 ]
336
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
null
Psoriasis
Plaque-type Psoriasis Psoriasis
null
2
arm 1: U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. arm 2: Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). intervention 2: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding...
intervention 1: U0267 intervention 2: Vehicle
13
San Diego | California | United States | -117.16472 | 32.71571 Denver | Colorado | United States | -104.9847 | 39.73915 Miami | Florida | United States | -80.19366 | 25.77427 Miami | Florida | United States | -80.19366 | 25.77427 Louisville | Kentucky | United States | -85.75941 | 38.25424 Boston | Massachusetts | Unit...
0
NCT00688519
[ 3 ]
118
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
null
Moderate to Severe COPD
COPD
null
2
arm 1: AZD1981 Oral tablet, twice daily arm 2: Placebo Oral tablet, twice daily
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Oral tablet, twice daily intervention 2: Placebo Oral tablet, twice daily
intervention 1: AZD1981 intervention 2: Placebo
21
Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Arhus C | N/A | Denmark | N/A | N/A Hellerup | N/A | Denmark | 12.57093 | 55.73204 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Værløse |...
0
NCT00690482
[ 4 ]
17
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
true
This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.
null
Cystic Fibrosis Pancreatic Exocrine Insufficiency
Cystic Fibrosis Pancreatic Exocrine Insufficiency
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 12,000 unit Capsules, dosed individually based on fat intake. intervention 2: Placebo
intervention 1: Pancrelipase Delayed Release intervention 2: Placebo Comparator
10
Iowa City | Iowa | United States | -91.53017 | 41.66113 Louisville | Kentucky | United States | -85.75941 | 38.25424 Boston | Massachusetts | United States | -71.05977 | 42.35843 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Albuquerque | New ...
0
NCT00690820
[ 3 ]
184
NON_RANDOMIZED
SINGLE_GROUP
2DIAGNOSTIC
1SINGLE
true
0ALL
false
Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).
null
Alzheimer's Disease Mild Cognitive Impairment
null
3
arm 1: None arm 2: MCI (mild cognitive impairment) arm 3: None
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: IV injection, 370MBq (10mCi), single dose
intervention 1: florbetapir F 18
15
Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Sun City | Arizona | United States | -112.27182 | 33.59754 Tucson | Arizona | United States | -110.92648 | 32.22174 Costa Mesa | California | United States | -117.91867 | 33.64113 New Haven | Connectic...
0
NCT00702143
[ 3 ]
142
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing symptoms of depression in patients with Major Depressive Disorder. The safety and tolerability of the combination product will also be ev...
Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.
Major Depressive Disorder
depression
null
3
arm 1: BCI-024: over-encapsulated Buspirone tablet 15 mg at bedtime(QD) and BCI-049: over-encapsulated Melatonin tablet 3 mg QD arm 2: BCI-024: over-encapsulated Buspirone 15 mg QD arm 3: Placebo: 1 capsule QD
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and Drug BCI-049: over-encapsulated Melatonin tablet 3 mg QD taken in combination for 6 weeks intervention 2: Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks. intervention 3: Placebo comparator once a day at bedtime for 6 weeks.
intervention 1: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD intervention 2: BCI-024 (Buspirone) intervention 3: Matching placebo
9
Garden Grove | California | United States | -117.94145 | 33.77391 San Diego | California | United States | -117.16472 | 32.71571 Altanta | Georgia | United States | N/A | N/A Rockville | Maryland | United States | -77.15276 | 39.084 Beachwood | Ohio | United States | -81.50873 | 41.4645 Philadelphia | Pennsylvania | Un...
0
NCT00705003
[ 3 ]
87
null
PARALLEL
0TREATMENT
null
false
2MALE
null
The primary objective of this trial is to estimate and compare the 12-week progression-free rate of BIBF 1120, BIBW 2992 or sequential administration of BIBF 1120 and BIBW 2992 in patients with HRPC as determined by radiographic, bone and PSA criteria.
null
Prostatic Neoplasms
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: BIBF 1120 intervention 2: BIBW 2992 intervention 3: Sequential BIBF 1120 + BIBW 2992
9
Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Bournemouth | N/A | United Kingdom | -1.8795 | 50.72048 Brighton | N/A | United Kingdom | -0.13947 | 50.82838 Cheltenham | N/A | United Kingdom | -2.07972 | 51.90006 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Newcastle upon Tyne | N/A | United Kingdom | -1....
0
NCT00706628
[ 5 ]
16
RANDOMIZED
CROSSOVER
2DIAGNOSTIC
1SINGLE
true
0ALL
false
The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function. In this case, the medication pregabalin will be used. The investigators hypothesize that pregabalin (at doses of 50 mg and 200 mg, versus...
Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a differ...
Anxiety Disorders
anxiety functional magnetic resonance imaging fMRI pregabalin Lyrica
null
3
arm 1: Pregabalin oral tablets (50 mg) arm 2: Pregabalin oral tablets (200 mg) arm 3: Placebo
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan intervention 2: One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan intervention 3: One dose of matched oral placebo to be administered one hour prior to fMRI scan
intervention 1: Pregabalin 50mg intervention 2: Pregabalin 200 MG intervention 3: placebo
1
La Jolla | California | United States | -117.2742 | 32.84727
0
NCT00706836
[ 0 ]
40
NON_RANDOMIZED
PARALLEL
null
0NONE
true
1FEMALE
false
There are over 60 million women of reproductive age in the U.S. and a majority of these women qualify as overweight or obese. Evidence suggests that there is an association between increased body weight and decreased contraceptive efficacy. Studies with the combined hormonal contraceptive patch (Evra®) and the subderma...
null
Pharmacokinetics
contraceptive ring obesity pharmacokinetics pharmacodynamics Pharmacokinetics of the contraceptive ring in obese women.
null
2
arm 1: Obese subjects (BMI 30-39.9)received two contraceptive hormonal rings. During the second cycle of ring use, subjects returned to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use. arm 2: Normal weight subjects (BMI 19-24.9) received ...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Obese subjects (BMI 30-39.9) will receive two contraceptive hormonal rings. During the second cycle of ring use, subjects will return to the study site for serial serum hormone measurements and transvaginal ultrasound twice weekly during four weeks of continuous use. intervention 2: Normal weight subjec...
intervention 1: NuvaRing intervention 2: NuvaRing
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00710606
[ 5 ]
7
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded, randomized, crossover study in which single doses of placebo, will be compared to Fluticasone propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen challenge, at cessation of the early allergic re...
The aim of this pilot study is to evaluate whether fluticasone propionate affects the late allergic reaction after a single dose post-allergen challenge administered following cessation of the early allergic reaction. Six subjects with mild asthma will be asked to volunteer for the study.The diagnosis of asthma will b...
Mild Intermittent Asthma
late allergic response fluticasone propionate
null
3
arm 1: Fluticasone propionate (Flovent Diskus) 250 mcg arm 2: budesonide 400mcg arm 3: placebo
[ 1, 1, 2 ]
3
[ 0, 0, 10 ]
intervention 1: Flovent Diskus 250 mcg intervention 2: budesonide 400 mcg intervention 3: Placebo
intervention 1: Fluticasone propionate (Flovent Diskus) 250 mcg intervention 2: budesonide 400 mcg intervention 3: Placebo
1
Hamilton | Ontario | Canada | -79.84963 | 43.25011
0
NCT00716963
[ 4 ]
259
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or i...
null
Controlled Ovarian Stimulation
Reproductive techniques assisted
null
2
arm 1: ganirelix arm 2: triptorelin
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: On day 6 of recFSH treatment, Org 37462 treatment will start by daily SC administration (0.25 mg) up to and including the day of hCG administration. intervention 2: a daily dose of 0.05 mg SC is to be injected. Triptorelin treatment will start in the luteal phase at day 21-24 of the menstrual cycle. Tre...
intervention 1: ganirelix intervention 2: triptorelin
0
null
0
NCT00725491
[ 5 ]
261
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine.
null
Perennial Allergic Rhinitis
null
3
arm 1: Pediatrics 3 to 6 years arm 2: Pediatrics 7 to 15 years arm 3: Adults 16 to 64 years
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks intervention 2: loratadine 10 mg tablet once daily for 4 weeks intervention 3: loratadine 10 mg tablet once daily for 4 weeks
intervention 1: loratadine intervention 2: loratadine intervention 3: loratadine
0
null
0
NCT00730912
[ 3 ]
37
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.
null
Asthma Airway Obstruction
Asthma airway obstruction beta2-agonist efficacy inhalation
null
6
arm 1: AZD3199 120 microgram arm 2: AZD3199 480 microgram arm 3: AZD3199 1920 microgram arm 4: Placebo arm 5: Formoterol 9 microgram arm 6: Formoterol 36 microgram
[ 0, 0, 0, 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Dry powder for inhalation, single dose intervention 2: Dry powder for inhalation, single dose intervention 3: Dry powder for inhalation, single dose
intervention 1: AZD3199 intervention 2: Formoterol intervention 3: Placebo
4
Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Luleå | N/A | Sweden | 22.15465 | 65.58415 Lund | N/A | Sweden | 13.19321 | 55.70584
0
NCT00736489
[ 2 ]
68
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.
null
Chronic Asthma
Chronic asthma
null
4
arm 1: montelukast Placebo arm 2: montelukast arm 3: montelukast arm 4: montelukast
[ 2, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelu...
intervention 1: Comparator: montelukast intervention 2: Comparator: placebo
0
null
0
NCT00739297
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.
null
Sarcoidosis
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
intervention 1: Abatacept
1
Chicago | Illinois | United States | -87.65005 | 41.85003
0
NCT00739960
[ 4 ]
9
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.
This is a multinational study with sites in the US, India, Singapore, South Korea, Mexico and Chile. There will be 210 subjects (male or female) enrolled that are residing in community or facilities with a reliable caregiver that have been clinically diagnosed with Down syndrome. The assessments performed during this s...
Down Syndrome Cognitive Dysfunction
pediatric Down syndrome cognitive dysfunction Downs Aricept children with Down syndrome
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: All subjects will start with a dose of 1.25 mg/day (1.25 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil. All doses will be administered orally. intervention 2: All subjects will start with a dose of 1.25 mg/day (1.25 ml) placebo; dose escalations wil...
intervention 1: Aricept (Donepezil hydrochloride) intervention 2: Placebo
2
San Antonio | Texas | United States | -98.49363 | 29.42412 Herndon | Virginia | United States | -77.3861 | 38.96955
0
NCT00754013
[ 4 ]
8
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, aged 11 to 17.
The study will be conducted in approximately 75 sites in the US, India, Singapore, South Korea, Mexico and Chile and will include 210 participants to be enrolled.
Down Syndrome Cognitive Dysfunction
Pediatric Down syndrome Downs Cognitive Dysfunction of Down syndrome
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalation will occur every 2 weeks to a maximum of 5 mg/day (5 ml) donepezil. All doses will be administered orally. intervention 2: All participants will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalation...
intervention 1: Aricept (donepezil hydrochloride) intervention 2: Aricept (donepezil hydrochloride) intervention 3: Placebo
2
San Antonio | Texas | United States | -98.49363 | 29.42412 Herndon | Virginia | United States | -77.3861 | 38.96955
0
NCT00754052
[ 3 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle, applied twice daily for 12 weeks, in the treatment of plaque type psoriasis
This is a single center, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily for 12 weeks. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test...
Psoriasis
Plaque Type Psoriasis Topical
null
2
arm 1: AN2728 Ointment, 5% arm 2: AN2728 Ointment vehicle
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: AN2728 Ointment, 5%, twice daily for 12 weeks intervention 2: Ointment vehicle, twice daily for 12 weeks
intervention 1: AN2728 intervention 2: Ointment vehicle
1
Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
0
NCT00755196
[ 2 ]
25
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006
null
Type 2 Diabetes Mellitus
null
12
arm 1: Participants received 15 mg MK1006 in Period 1, followed by placebo to MK1006 in Period 2, followed by 45 mg MK1006 in Period 3, followed by 60 mg MK1006 in Period 4, followed by placebo to MK1006 taken with food (Fed state) in Period 5. arm 2: Participants received placebo to MK1006 in Period 1, followed by 30 ...
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: MK1006 capsules: 1 mg, 10 mg, and 20 mg. Panel A: MK1006 capsules in five doses beginning at 15 mg and rising to 60 mg Panel B: MK1006 capsules in five doses beginning at 60 mg and rising to 140 mg. Panel C: MK1006 capsules in five doses beginning at 140 mg and rising to 260 mg. There will a 7-day i...
intervention 1: MK1006 intervention 2: Placebo
0
null
0
NCT00757601
[ 5 ]
500
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.
null
Pain
null
1
arm 1: Etoricoxib
[ 0 ]
1
[ 0 ]
intervention 1: etoricoxib 60 mg QD for 4 weeks.
intervention 1: etoricoxib
0
null
0
NCT00757627
[ 4 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
true
0ALL
true
Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.
null
Periodontitis
null
2
arm 1: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. arm 2: Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses. intervention 2: Swished around whole mouth twice daily for 12 month...
intervention 1: Triclosan/copolymer/fluoride intervention 2: Fluoride
0
null
0
NCT00762762
[ 4 ]
626
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
Hypersensitivity
null
Dentin Hypersensitivity
null
2
arm 1: sensitive toothpaste arm 2: Triclosan control toothpaste
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Brush twice daily intervention 2: Brush twice daily
intervention 1: Triclosan, Silicon dioxide, fluoride intervention 2: Triclosan, fluoride
1
Cedar Knolls | New Jersey | United States | -74.44876 | 40.82204
0
NCT00763269
[ 3 ]
45
RANDOMIZED
FACTORIAL
null
0NONE
true
0ALL
false
To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the entry inhibitor maraviroc. COL112237 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and maraviroc (MVC) pharmacokinetics in 48 ...
This randomized, open-label, six-arm, three-period drug interaction study will recruit 48 healthy volunteers so as to obtain a minimum of 36 evaluable subjects at a single study center in the U.S. The study will have a screening visit, 3 treatment visits for PK sampling and a follow-up visit. The screening visit will b...
Healthy
Healthy Subjects Pharmacokinetics study Pharmacokinetics of medications
null
6
arm 1: Period 1-Maraviroc 300mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Maraviroc 300mg BID arm 2: Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 1400mg BID + Maraviroc 300mg BID Period 3-Fosamprenavir 1400mg BID arm 3: Period 1-Maraviroc 300mg BID Period 2-Fosamprenavir 700mg B...
[ 1, 1, 1, 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 300 mg BID intervention 2: 1400 mg BID, 700 mg BID or 1400 mg QD intervention 3: 100 mg BID, 100 mg QD
intervention 1: Maraviroc intervention 2: Fosamprenavir intervention 3: Ritonavir
1
Voorhees Township | New Jersey | United States | -74.49062 | 40.4795
0
NCT00764465
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
2DOUBLE
false
0ALL
true
• To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)
• 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Patient will complete a subject evaluation at each visit. Follow-up visits occur at Day 3, 7, 14, 30 and 90.
Acne Vulgaris
acne Botox cosmetic treatments
null
1
arm 1: Botulinum Neurotoxin Type A (Botox, 1.5-3 units/lesion); Bacteriostatic saline solution (0.11 cc/lesion)
[ 0 ]
2
[ 0, 0 ]
intervention 1: 1.5-3 units of Botox/lesion intervention 2: .1 cc bacteriostatic saline/lesion
intervention 1: Botulinum Neurotoxin Type A intervention 2: Bacteriostatic saline
1
Chicago | Illinois | United States | -87.65005 | 41.85003
0
NCT00765375
[ 2 ]
34
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a...
null
Familial Adenomatous Polyposis
Polyp, Familial Adenomatous Polyposis, Prevention
null
2
arm 1: 20 grams BRB Slurry BID plus two, 730 mg BRB suppositories HS arm 2: 20 grams BRB Placebo Slurry BID plus two, 730 mg BRB suppositories HS
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 20 grams BRB Slurry intervention 2: Two, 730 mg BRB suppositories QHS intervention 3: 20 grams BRB placebo slurry
intervention 1: Black raspberry (BRB) Slurry intervention 2: Black Raspberry (BRB) Suppositories intervention 3: Black Raspberry (BRB) Placebo Slurry
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00770991
[ 5 ]
165
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.
null
Attention-Deficit/Hyperactivity Disorder (ADHD)
ADHD, children, subjects, laboratory classroom
null
3
arm 1: Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days. arm 2: Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days. arm 3: Two Capsules taken orally once a day for 7 days
[ 0, 1, 2 ]
2
[ 0, 0 ]
intervention 1: 10 mg and/or 20 mg capsules intervention 2: Placebo Comparator
intervention 1: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR) intervention 2: Placebo
8
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Bradenton | Florida | United States | -82.57482 | 27.49893 South Miami | Florida | United States | -80.29338 | 25.7076 Overland Park | Kansas | United States | -94.67079 | 38.98223 Las Vegas | Nevada | United States | -115.13722 | 36.17497 Houston | Texas | ...
0
NCT00776009
[ 0 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the response rate of the combination of bortezomib and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS).
In patients who develop acute myelogenous leukemia (AML) or a high-risk myelodysplastic syndrome (MDS), the current standard treatment involves multidrug induction chemotherapy utilizing an anthracycline or anthraquinone with cytarabine. While chemotherapy has proven effective at inducing remission in up to 90% of pati...
Acute Myelogenous Leukemia Myelodysplastic Syndromes
Acute Myelogenous Leukemia AML Myelodysplastic Syndromes MDS Melphalan Bortezomib Velcade
null
1
arm 1: All patients will receive the following regimen: 1) Melphalan 2 mg orally, once daily. 2) Bortezomib 1.0 mg/M2 IV on days 1, 4, 8, 11.
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Melphalan: 2mg orally, once daily intervention 2: Bortezomib: 1.0mg/M2 IV on days 1, 4, 8, 11 intervention 3: None
intervention 1: Melphalan intervention 2: Bortezomib intervention 3: Melphalan and bortezomib
2
Jacksonville | Florida | United States | -81.65565 | 30.33218 Lebanon | New Hampshire | United States | -72.25176 | 43.64229
0
NCT00789256
[ 3 ]
132
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in the...
null
Allergic Rhinitis
Allergic Rhinitis Pediatric PATANASE
null
2
arm 1: Olopatadine Hydrochloride Nasal Spray 0.6% arm 2: Olopatadine Hydrochloride Nasal Spray Vehicle
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: one spray in each nostril twice daily for 2 weeks intervention 2: one spray in each nostril twice daily for 2 weeks
intervention 1: Olopatadine Hydrochloride Nasal Spray 0.6% intervention 2: Olopatadine Hydrochloride Nasal Spray Vehicle
1
Waco | Texas | United States | -97.14667 | 31.54933
0
NCT00794144
[ 4 ]
2
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participants with chronic (lasting a long time) malignant (cancerous) cancer pain.
This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomized (the study drug is assigned by chance) study to evaluate safety and efficacy of OROS extended-release (ER) hydromorhon...
Cancer Pain
Pain Hydromorphone hydrochloride OROS Morphine
null
2
arm 1: Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase. arm 2: Participants will receive morphine SR 8 mg every 24 hours, for 3 to14 days...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Participants will receive hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS will be continued as per Investigator's discretion for next 14 days of maintenance phase. intervention 2: Participants will receive morphine SR 8 mg every24 hours...
intervention 1: Hydromprphone Hydrochloride (HCl) OROS intervention 2: Morphine Sustain Release (SR)
0
null
0
NCT00803283
[ 5 ]
30
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
null
Glaucoma, Open Angle Ocular Hypertension
null
6
arm 1: Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5% arm 2: Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5% arm 3: Period one - Timolol maleate gel forming ...
[ 1, 1, 1, 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 0.5% intervention 2: 0.5% intervention 3: 0.5%
intervention 1: Timolol Maleate in Sorbate intervention 2: Timolol hemihydrate intervention 3: Timolol maleate gel forming solution
2
Bourbonnais | Illinois | United States | -87.88754 | 41.15376 Charlotte | North Carolina | United States | -80.84313 | 35.22709
0
NCT00804648
[ 5 ]
30
RANDOMIZED
CROSSOVER
null
1SINGLE
true
0ALL
false
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.
null
Normal Healthy Subject Population
null
2
arm 1: Zegerid® arm 2: Prilosec OTC®
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: capsule(20 mg omeprazole/sodium bicarbonate), single dose intervention 2: Omeprazole-magnesium 20.6 mg, tablet, single dose
intervention 1: Zegerid® intervention 2: Prilosec OTC®
1
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
0
NCT00808769
[ 5 ]
226
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
true
1FEMALE
false
This study proposes a double blind randomized clinical trial to include normal weight and obese women who have normal ovulatory function at baseline; the investigators will randomize women to 2 widely used OCs and evaluate ovarian follicle development and circulating progesterone to assess ovarian suppression during OC...
There is a large gap between lowest expected failure rates of about 1.5% and typical use failure rates of about 7% per year. This gap may be due to incorrect use or to decreased oral contraceptive (OC) effectiveness in population subgroups. Recent reports suggest greater OC failure among heavier women, particularly tho...
Ovarian Suppression
Ovarian Suppression Oral Contraceptives Obese and Normal BMI
null
2
arm 1: Participants with a BMI of 19-24.9 kg/m\^2 arm 2: Participants with a BMI of 30-39.9 kg/m\^2
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Participants are randomized to either Portia (levonorgestrel/ethinyl estradiol tablets, United States Pharmacopeia (USP)0.15 mg/0.03 mg or Lessina (levonorgestrel/ethinyl estradiol tablets, USP 0.1 mg/0.02 mg) for 3 months use. Dose formula contains 20 ug of ethinyl estradiol (EE) and 100 ug of levonor...
intervention 1: Low dose formulation intervention 2: High dose formulation
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00827632
[ 2 ]
52
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
2MALE
false
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.
null
Healthy
Rotigotine Neupro® Transdermal Patch
null
2
arm 1: Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days arm 2: Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 day...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Rotigotine 4.5mg/10cm\^2 patch applied for 24 hours
intervention 1: Rotigotine transdermal patch
1
Neuss | North Rhine-Westphalia | Germany | 6.68504 | 51.19807
0
NCT00881894
[ 3 ]
5
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Evaluation of CD4 in combination with CHO chemotherapy in subjects with nodal involvement of non cutaneous Tcell lymphoma.
null
T-cell Lymphoma
non cutaneous peripheral t-cell lymphoma with nodal involvement
null
2
arm 1: CHOP chemo therapy + CD4 therapy arm 2: CHOP chemotherapy
[ 0, 1 ]
2
[ 2, 0 ]
intervention 1: None intervention 2: None
intervention 1: CHOP + CD4 intervention 2: CHOP
0
null
0
NCT00893516
[ 4 ]
85
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will provide data on additional therapeutic benefits in administering Adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of treatment with etanercept.
A total of 50 patients with psoriasis vulgaris who showed an unsatisfactory response to etanercept 50 mg twice a week followed by 50 mg once a week and a total of 50 patients who showed an unsatisfactory response to etanercept 50 mg twice a week without dose reduction will be recruited. All patients will receive adalim...
Plaque Psoriasis
Adalimumab
null
4
arm 1: Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening. arm 2: Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercep...
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Adalimumab 40mg injection every other week for 24 weeks intervention 2: Adalimumab 40mg injection every week for the last 12 weeks of study.
intervention 1: Adalimumab every other week intervention 2: Adalimumab Every Week
12
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 London | Ontario | Canada | -81.23304 | 42.98339 London | Ontario | Canada | -81.23304 | 42.98339 Markham | Ontario | Canada | -79.2663 | 43.86682 Oakville | Ontario | Canada | -79.68292 | 43.45011 ...
0
NCT00927069
[ 5 ]
24
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
2MALE
false
The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.
null
Bacterial Infection
Bioequivalence
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Tablet, 100 mg, Single dose intervention 2: Tablet, 100 mg, Single dose
intervention 1: doxycycline monohydrate tablet intervention 2: doxycycline carragenate tablet
1
Ahmedabad | Gujarat | India | 72.58727 | 23.02579
0
NCT00939562
[ 5 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Study Status: Duke University Health System Institutional Review Board has received notification of study termination; final IRB closure date is 12/12/2008. Study enrollment is now closed. Enrollment Update: Only one subject was entered into this study out of an expected enrollment of 15 patients in this single site...
This is an open-label study using alefacept in the treatment of patients with chronic plaque psoriasis who have not responded to treatment with an anti-TNF agent. Patients not responding to Enbrel® 50 mg weekly with a 75% reduction of Psoriasis Area and Severity Index (PASI) Score or a Physician Global Assessment (PGA)...
Chronic Plaque Psoriasis
null
1
arm 1: Alefacept will be given to subjects with plaque psoriasis who have failed treatment with Fnbrel.
[ 0 ]
1
[ 0 ]
intervention 1: Alefacept 15 mg IM once a week were to be administered for 12 weeks, which is the FDA approved dosage, duration, and frequency. This study allowed an additional 8 doses if subject did not achieve a 'clear' response with the original 12 weeks of treatment. Each enrolled subject must have failed a respons...
intervention 1: alefacept
0
null
0
NCT00953329
[ 2 ]
26
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
true
2MALE
false
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strengt...
Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing age regardless of their level of physical activity. A 12-yr longitudinal study in healthy sedentary older men showed a correlation between loss of muscle cross-sectional area and muscle strength of the thigh, quadriceps, and f...
Hypogonadism
Low Normal Testosterone Male Aging
null
3
arm 1: Weekly placebo treatment for a duration of 5 months. arm 2: A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months. arm 3: Weekly testosterone treatment for a duration of 5 months
[ 2, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Weekly im injections of 100 mg testosterone enanthate. intervention 2: Weekly IM injections of sesame oil.
intervention 1: Testosterone intervention 2: Placebo
1
Galveston | Texas | United States | -94.7977 | 29.30135
0
NCT00957528
[ 0 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
false
The investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session. This is a randomized three period cross-over study including treatment with Terbutaline, a 20% basal reduction for six hours, or no treat...
In this study, a minimum of 16 youth with type 1 diabetes will be recruited. All subjects must have been diagnosed with type 1 diabetes for at least one year and on an insulin pump for at least one month. Subjects are between the ages of 10 and 17 years, inclusive, have an HbA1c less than 10.0% and normal thyroid funct...
Type 1 Diabetes
Children Exercise Hypoglycemia
null
3
arm 1: Subjects complete the same exercise routine, however no treatment is given at 9:00pm. arm 2: Subjects complete same exercise routine. At 9:00pm, an oral dose of 2.5 mg of Terbutaline is administered. arm 3: All subjects complete the same exercise session. At 9:00pm, subject's basal rate is decreased by 20% for s...
[ 1, 0, 0 ]
3
[ 0, 10, 10 ]
intervention 1: Oral (2.5mg) one time administration at 9:00pm intervention 2: Basal insulin rate is reduced by 20% the normal (home dose) for six hours. intervention 3: No treatment is given for the study. This arm is for comparison with the two intervention arms.
intervention 1: Terbutaline intervention 2: 20% basal insulin reduction intervention 3: Control
1
Aurora | Colorado | United States | -104.83192 | 39.72943
0
NCT00974051
[ 4 ]
41
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism \[VTE\] (i.e., Pulmonary thromboembolism \[PE\] and Deep Vein Thrombosis \[DVT\])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.
null
Embolism, Pulmonary
Fondaparinux sodium contrast-enhanced MDCT Deep Vein Thrombosis Pulmonary thromboembolism
null
2
arm 1: None arm 2: None
[ 0, 5 ]
2
[ 0, 0 ]
intervention 1: The dose of Fondaparinux will be determined based on a subject's body weight (\<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; \>100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection. intervention 2: UFH therapy will be started on Day 1 while adjusting activated partial thromboplastin time (aPTT...
intervention 1: Fondaparinux sodium intervention 2: unfractionated heparin (UFH)
27
Aichi | N/A | Japan | 130.62158 | 32.51879 Chiba | N/A | Japan | 140.11667 | 35.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Gunma | N/A | Japan | N/A | N/A Gunma | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Ibaraki | N/A | Japa...
0
NCT00981409
[ 4 ]
54
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.
The accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. Treatment with st...
Abdominal Obesity
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 10 mg once daily intervention 2: once daily
intervention 1: Rosuvastatin intervention 2: Placebo for rosuvastatin
1
Gothenburg | N/A | Sweden | 11.96679 | 57.70716
0
NCT01068626
[ 3 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug.
This was a Phase 2, parallel-group, active-control, randomized, double-blind study conducted to evaluate a single local administration of low dose or high dose of SKY0402 compared with 75 mg of bupivacaine HCl (i.e., Marcaine® 0.5%) in women undergoing bilateral, cosmetic, sub-muscular, augmentation mammoplasty under g...
Postoperative Pain
Breast augmentation Pain Analgesia
null
2
arm 1: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 arm 2: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket intervention 2: Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket
intervention 1: SKY0402 + bupivacaine HCl intervention 2: Mid-dose SKY0402 + bupivacaine HCl
1
La Jolla | California | United States | -117.2742 | 32.84727
0
NCT01206608
[ 3 ]
30
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
null
The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.
null
Primary Open Angle Glaucoma
null
2
arm 1: One drop. arm 2: One drop
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: One drop at 8.00pm. intervention 2: One drop at 8.00pm.
intervention 1: T2345 intervention 2: Prostaglandin
0
null
0
NCT01494753
[ 4 ]
188
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnose...
Schizophrenia
Schizophrenia Paliperidone ER Treatment naive patients Newly diagnosed patients
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
intervention 1: Paliperidone ER
0
null
0
NCT01606228
[ 0 ]
140
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.
null
Kidney Stone
null
2
arm 1: ESWL with hydration and inversion arm 2: ESWL with hydration
[ 0, 1 ]
3
[ 3, 3, 0 ]
intervention 1: Patients inverted 30 degree head down in Trendelenburg position intervention 2: Shock wave lithotripsy intervention 3: Hydration of patient with 0.5L NaCl and 20mg frusemide IV
intervention 1: Inversion intervention 2: Shock Wave Lithotripsy intervention 3: Hydration
0
null
0
NCT01852669
[ 4 ]
160
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and fluocinolone) in the treatment of symptoms caused by the presence of vaginitis (inflammation of ...
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), comparative, parallel (a clinical trial comparing the response in 2 or more groups of participants receiving different treatments) doubl...
Vaginitis Infectious Vaginosis
Vaginitis Infectious vaginosis Terconazole Clindamycin Fluocinolone Metronidazole Nystatin
null
2
arm 1: One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days. arm 2: One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be admini...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days. intervention 2: One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nysta...
intervention 1: Gynoclin V intervention 2: Vagitrol V
2
DF | Mexico City | Mexico | N/A | N/A Mexico City | N/A | Mexico | -99.12766 | 19.42847
0
NCT01867164
[ 3 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.
The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study. This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis...
Hyperkalemia
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 15 grams/day (5 grams 3 times daily) administered orally
intervention 1: patiromer
2
Orlando | Florida | United States | -81.37924 | 28.53834 Minneapolis | Minnesota | United States | -93.26384 | 44.97997
0
NCT02033317
[ 4 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will compare the efficacy of CellCept \[0.5-2 grams per day (g/day) orally (p.o.)\] and cyclophosphamide \[0.5-1 grams per square meter (g/m2) quarterly\] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 ...
null
Lupus Nephritis
null
2
arm 1: Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m\^2), intravenously (IV) pulse once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), orally (PO); the dose was reduced by 5 mg/day to a final dose o...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase. intervention 2: 0.5-1 g/m\^2 IV pulse once every 3 months intervention 3: 0.5 - 1 g/m\^2 IV pulse once per month intervention 4: 1 mg/kg PO once per day; reduced by 5 mg eve...
intervention 1: Mycophenolate mofetil (MMF) intervention 2: Cyclophosphamide, Maintenance Phase intervention 3: Cyclophosphamide, Induction Phase intervention 4: Prednisone
2
Barquisimeto | N/A | Venezuela | -69.35703 | 10.0647 Caracas | N/A | Venezuela | -66.87919 | 10.48801
0
NCT02081183
[ 2 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
2MALE
false
To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25)
Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least 14 days. On each treatment period, after completion of pre-dose assessments, BIA 9-1067/Placebo was to be administered concomitantly with ...
Parkinson's Disease (PD)
Parkinson's disease (PD) Opicapone BIA 9-1067
null
4
arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25 arm 2: Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067...
[ 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: OPC, Opicapone intervention 2: PLC, Placebo intervention 3: Immediate-release levodopa/carbidopa 100/25 mg
intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Sinemet® 100/25
1
Mount Royal | Quebec | Canada | -73.64918 | 45.51675
0
NCT02169479
[ 2 ]
17
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study tre...
null
Non-Small Cell Lung Cancer
Non-Squamous
null
2
arm 1: Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 100 mg orally (PO). arm 2: Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, follo...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Erlotinib will be administered as oral tablets. intervention 2: Pertuzumab will be administered as intravenous (IV) infusion.
intervention 1: Erlotinib intervention 2: Pertuzumab
3
Antwerp | N/A | Belgium | 4.40026 | 51.22047 Barcelona | N/A | Spain | 2.15899 | 41.38879 Manchester | N/A | United Kingdom | -2.23743 | 53.48095
0
NCT02507375
[ 4 ]
31
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.
null
Hepatitis D, Chronic
null
1
arm 1: Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
[ 0 ]
1
[ 0 ]
intervention 1: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
intervention 1: Pegylated Interferon (PEG-IFN) alfa-2a
7
Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Constanța | N/A | Romania | 28.63432 | 44.18073 Craiova | N/A | Romania | 23.8 | 44.31667 Iași | N/A | Romania | 27.6 | 47.16667 Timișoara | N/A | Romania | 21.22571 | 45.75372
0
NCT02732639
[ 2 ]
48
RANDOMIZED
SEQUENTIAL
0TREATMENT
2DOUBLE
true
0ALL
false
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.
null
Postmenopausal Osteopenia
null
2
arm 1: Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for 3 months. arm 2: Participants were randomized to receive romosozumab administered by subcutaneous injection at doses of 1 mg/kg Q2W, 2 mg/kg Q4W, 2 mg/kg Q2W, o...
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection
intervention 1: Romosozumab intervention 2: Placebo
0
null
0
NCT01825785
[ 3 ]
54
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
This is a randomized, placebo-controlled, safety and tolerability study examining MK-8777 in participants with major depressive disorder. In Part I of the trial, four different cohorts of six participants each will receive multiple rising doses of MK-8777 (ranging from 100 mg twice a day \[BID\] to 300 mg BID) or place...
Depression
randomized placebo controlled maximum tolerated dose
null
11
arm 1: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. arm 2: Participants receive placebo BID for a total of 16 days. arm 3: Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. P...
[ 0, 2, 0, 2, 0, 2, 0, 2, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Orally administered capsules containing either 50 mg or 100 mg MK-8777. intervention 2: Orally administered matching placebo capsules.
intervention 1: MK-8777 intervention 2: Placebo
0
null
0
NCT00610649
[ 3 ]
5
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) as...
null
Post-Traumatic Stress Disorder Stress Disorders, Post-Traumatic
PTSD (Posttraumatic Stress Disorder) CAPS fMRI Paroxetine
null
2
arm 1: Drug 2 (20 mg/day or placebo) will be administered once daily after supper for the first two weeks after the run-in phase. If the investigator/subinvestigator judges that a sufficient response is achieved, Drug 2 will be continued for the remaining period. If a sufficient response is not achieved with Drug 2 but...
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) intervention 2: placebo
intervention 1: paroxetine intervention 2: placebo
9
Chiba | N/A | Japan | 140.11667 | 35.6 Chiba | N/A | Japan | 140.11667 | 35.6 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 ...
0
NCT00557622
[ 2 ]
17
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.
This study includes two parts, each part includes three consecutive 28-day treatment periods. Part 1 (to be conducted in the United States): each participant will receive the following treatments for 28 days in each of three treatment periods in an order determined by a random code: SCH 497079, or matching placebo, or ...
Type 2 Diabetes Mellitus
null
6
arm 1: Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks. arm 2: Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks. arm 3: Participants received metformin daily f...
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks intervention 2: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks intervention 3: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)
intervention 1: SCH 497079 intervention 2: Placebo intervention 3: Metformin
0
null
0
NCT00673465
[ 3 ]
117
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.
All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug do...
Down Syndrome
null
1
arm 1: All participants started with a dose of 2.5 mg/day (2.5 mL/day). Dose escalations occurred in 2.5 mg/day increments every 2 weeks (steady state levels assumed to have been reached) to a maximum dose of 10 mg/day, according to the participant's weight schedule and the Investigator's judgment of safety and tolerab...
[ 0 ]
1
[ 0 ]
intervention 1: Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
intervention 1: Donepezil hydrochloride (Aricept)
31
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Orange | California | United States | -117.85311 | 33.78779 San Diego | Cal...
0
NCT00675025
[ 3 ]
10
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this research study is to look at concentrations of GSK189075 in blood when single doses of the drug are taken by mouth in combination with basal insulin. The clinical effects of the drug in combination with insulin on the body will also be studied. The results will help determine doses of GSK189075 can ...
null
Diabetes Mellitus, Type 1
type 1 Diabetes mellitus, pharmacokinetics, pharmacodynamics Adult male and females,
null
2
arm 1: GSK189075 arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: investigational drug intervention 2: placebo comparator
intervention 1: GSK189075 intervention 2: placebo
1
San Diego | California | United States | -117.16472 | 32.71571
0
NCT00575159
[ 4 ]
142
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting
This study has both an optimization and double-blind period
ADHD
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting intervention 2: Placebo administered once-daily for one week during the adult workplace environment setting
intervention 1: LDX intervention 2: Placebo
5
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Irvine | California | United States | -117.82311 | 33.66946 Overland Park | Kansas | United States | -94.67079 | 38.98223 Las Vegas | Nevada | United States | -115.13722 | 36.17497 Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00697515
[ 4 ]
301
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
null
Atrophy Vaginal Diseases
Menopausal symptoms Vulvar and vaginal atrophy in menopausal women Vaginal atrophy Urogenital atrophy
null
1
arm 1: Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Ospemifene 60Mg Oral Tablet
0
null
1
NCT01586364
[ 3 ]
576
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.
null
Pulmonary Disease, Chronic Obstructive
COPD Multicenter GSK233705B double-blind Chronic Obstructive Pulmonary Disease (COPD) randomized
null
6
arm 1: GSK233705 12.5mcg arm 2: GSK233705 25mcg arm 3: GSK233705 50mcg arm 4: GSK233705 100mcg arm 5: GSK233705 200mcg arm 6: Placebo
[ 0, 0, 0, 0, 0, 2 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Once daily via dry powder inhaler intervention 2: once daily via dry powder inhaler intervention 3: Once daily via dry powder inhaler intervention 4: Once daily via dry powder inhaler intervention 5: Once daily via dry powder inhaler intervention 6: Once daily via dry powder imhaler
intervention 1: GSK233705 12.5mcg intervention 2: GSK233705 25mcg intervention 3: GSK233705 50mcg intervention 4: GSK233705 100mcg intervention 5: GSK233705 200mcg intervention 6: Placebo
88
Jasper | Alabama | United States | -87.27751 | 33.83122 Glendale | Arizona | United States | -112.18599 | 33.53865 Fountain Valley | California | United States | -117.95367 | 33.70918 Fullerton | California | United States | -117.92534 | 33.87029 Los Angeles | California | United States | -118.24368 | 34.05223 Los Ange...
0
NCT00676052
[ 3 ]
27
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.
Hysterectomy is the second most common surgery among women in the United States (US). Abdominal hysterectomy surgery may be performed to treat benign tumors, such as fibroids, heavy periods, painful periods and chronic pelvic pain. The most common route for performing hysterectomy is through an incision in the abdomina...
Pain, Postoperative
Abdominal Hysterectomy Postoperative pain
null
2
arm 1: Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line. arm 2: Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride intervention 2: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
intervention 1: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) intervention 2: ON-Q PainBuster Post-op Pain relief System
1
Boynton Beach | Florida | United States | -80.06643 | 26.52535
0
NCT00749749
[ 3 ]
564
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
true
This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.
null
Osteoporosis
bone mineral density, Ronacaleret teriparatide alendronate, Post-menopausal women, osteoporosis, SB-751689
null
4
arm 1: All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 2: All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the st...
[ 4, 1, 1, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 100mg, 200mg, 300mg, 400mg intervention 2: PTH (1-34) intervention 3: Bisphosphonate
intervention 1: Ronacaleret intervention 2: Teriparatide intervention 3: Alendronate
49
Oakland | California | United States | -122.2708 | 37.80437 Palm Desert | California | United States | -116.37697 | 33.72255 Walnut Creek | California | United States | -122.06496 | 37.90631 Decatur | Georgia | United States | -84.29631 | 33.77483 Bethesda | Maryland | United States | -77.10026 | 38.98067 Akron | Ohio ...
0
NCT00471237
[ 3 ]
69
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
4QUADRUPLE
false
0ALL
true
To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance, ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients
Efficacy Measures: Endurance, Ambulation, Cognitive function, Insulin resistance, Cholesterol and triglycerides, Muscle function and strength, Pain, Gastrointestinal function, Quality of life MINIMUM INCLUSION CRITERIA 1. A diagnosis of DM1, confirmed by DM1 genetic mutation 2. Age 21 to 65 years (inclusive) 3. Abil...
Myotonic Dystrophy Type 1
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit. intervention 2: 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.
intervention 1: rhIGF-I/rhIGFBP-3 intervention 2: placebo
12
Orange | California | United States | -117.85311 | 33.78779 Sacramento | California | United States | -121.4944 | 38.58157 Kansas City | Kansas | United States | -94.62746 | 39.11417 Baltimore | Maryland | United States | -76.61219 | 39.29038 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 St Louis | Mis...
0
NCT00577577
[ 3 ]
76
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total bo...
This is a pilot study which began with a plan to enroll 50 patients (20 related and 30 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with Pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood s...
Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Myelodysplastic Syndromes Multiple Myeloma Non-Hodgkins Lymphoma Hodgkins Disease Peripheral T-cell Lymphoma
null
1
arm 1: Pentostatin to be administered intravenously on days - 10, -9, and -8 at a dose of 4mg/m2/day
[ 0 ]
5
[ 0, 4, 0, 0, 0 ]
intervention 1: 4 mg/m\^2 intravenous(IV)once a day(QD)x3days (days -10, -9, -8) intervention 2: TBI will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be...
intervention 1: Pentostatin intervention 2: Total-body irradiation (TBI) intervention 3: Cyclosporine A (CsA) intervention 4: Mycophenolate Mofetil (MMF) intervention 5: G-CSF
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
0
NCT00571662
[ 3 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.
This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pres...
Burns Sedation
pediatric burn sedation
null
1
arm 1: Ascending doses of dexmedetomidine (as per protocol)
[ 0 ]
1
[ 0 ]
intervention 1: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine \[in ug/kg/hr\], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.
intervention 1: Dexmedetomidine
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00697788
[ 5 ]
199
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
null
Alzheimer's Disease
Alzheimer's disease
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.
intervention 1: Donepezil
15
Bundang | N/A | South Korea | N/A | N/A Changwon | N/A | South Korea | 128.68111 | 35.22806 Chuncheon | N/A | South Korea | 127.73417 | 37.87472 Chungju | N/A | South Korea | 127.9287 | 36.97666 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daejeon | N/A | South Korea | 127.38493 | 36.34913 Gyeonggi-do | N/A | South...
0
NCT00381381
[ 4 ]
602
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
1FEMALE
false
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the...
null
Breast Neoplasms Osteoporosis
cancer-treatment related bone loss postmenopausal women breast cancer hormone receptor positive breast cancer adjuvant therapy hormonal therapy bone loss bisphosphonates ZFAST Letrozole Zoledronic Acid US32
null
2
arm 1: Participants in the upfront arm received zoledronate 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence) or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily. arm 2: In lieu of a placebo arm, which was considered...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Participants received Zoledronate 4 mg IV 15-minute infusion every 6 months. intervention 2: Participants received Letrozole 2.5 mg daily.
intervention 1: Zoledronic Acid intervention 2: Letrozole
44
Springdale | Arkansas | United States | -94.12881 | 36.18674 Burbank | California | United States | -118.30897 | 34.18084 Lafayette | California | United States | -122.11802 | 37.88576 LaVerne | California | United States | N/A | N/A Long Beach | California | United States | -118.18923 | 33.76696 Montebello | Californi...
1
NCT00050011
[ 4 ]
577
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.
null
Diabetic Nephropathy Type 2 Diabetes Mellitus Proteinuria
angiotensin II type I receptor blockers diabetic nephropathy end-stage renal disease renal failure type 2 diabetes olmesartan medoxomil
null
2
arm 1: Olmesartan medoxomil tablets 10mg to 40 mg arm 2: Matching placebo tablets
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tablets 10, 20, or 40 mg intervention 2: Matching placebo tablets
intervention 1: olmesartan medoxomil intervention 2: Placebo Tablets
2
Hong Kong | N/A | China | 114.17469 | 22.27832 Tokyo | N/A | Japan | 139.69171 | 35.6895
1
NCT00141453
[ 3 ]
172
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.
null
Carcinoma, Non-Small-Cell Lung Lung Neoplasms
Lung Cancer HKI-272 Neratinib Nerlynx
null
3
arm 1: HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening arm 2: HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarce...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.
intervention 1: HKI-272
19
Los Angeles | California | United States | -118.24368 | 34.05223 Zion | Illinois | United States | -87.83285 | 42.44613 Boston | Massachusetts | United States | -71.05977 | 42.35843 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 New York | New York | United States | -74.00597 | 40.71427 Charlotte | Nort...
1
NCT00266877
[ 5 ]
355
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to compare the effectiveness of two antipsychotic medications, Risperdal® Consta® versus Abilify®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.
Although many patients with schizophrenia currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations of antipsychotics may eliminate the need for daily medication and enhance patient compliance with the tr...
Schizophrenia Psychotic Disorders
Schizophrenia Relapse Remission Treatment Outcome long-acting injectable
null
2
arm 1: None arm 2: None
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: 10-30 mg once daily for 104 weeks intervention 2: 25mg, 37.5mg, or 50mg every 2 weeks for 104 weeks
intervention 1: Abilify intervention 2: Risperidal Consta
0
null
1
NCT00299702
[ 4 ]
3,221
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clot...
null
Deep Vein Thrombosis Pulmonary Embolism
Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery
null
2
arm 1: Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery. arm 2: Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixa...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 40 mg, administered once daily by subcutaneous injection, for 12 days intervention 2: 2.5 mg, administered twice daily as tablets, for 12 days intervention 3: Administered once daily by subcutaneous injection intervention 4: Oral tablet administered twice daily
intervention 1: Enoxaparin intervention 2: Apixaban intervention 3: Enoxaparin-matching placebo intervention 4: Apixaban-matching placebo
122
Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Linz | N/A | Austria | 14.28611 | 48.30639 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Wiener Neustadt | N/A | Austria | 16.23196 | 47.80485 An...
1
NCT00452530
[ 4 ]
903
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis.
This is a multicenter, randomized (study medication assigned by chance), active-controlled, parallel, 3-arm study. Patients will be randomly (allocation to treatments available by chance) assigned in 3:5:5 ratio to receive one of three treatments groups. The three treatment groups are: Group 1 - CNTO 1275 45 mg dosing ...
Psoriasis
Psoriasis CNTO 1275 Etanercept Immune diorder Skin disorder
null
3
arm 1: Patients will receive CNTO 1275 45 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. arm 2: Patients will receive CNTO 1275 90 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on PG...
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous intervention 2: Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous intervention 3: Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous
intervention 1: CNTO 1275 45 mg intervention 2: CNTO 1275 90 mg intervention 3: Etanercept 50 mg
0
null
0
NCT00454584
[ 4 ]
452
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) alon...
This is a randomized (assigned by chance), open-label (all people know the identity of the intervention), active-controlled, parallel-group (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter (when more than one hospital or medical school t...
Schizophrenia
Schizophrenia Paliperidone Paliperidone palmitate Risperidone Risperidone long acting injection R092670
null
2
arm 1: Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion. arm 2: Risperidone LAI intramuscular at a dose...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion. intervention 2: Risperidone LAI intra...
intervention 1: Paliperidone palmitate (R092670) intervention 2: Risperidone
8
Baoding | N/A | China | 115.46246 | 38.87288 Beijing | N/A | China | 116.39723 | 39.9075 Guangzhou | N/A | China | 113.25 | 23.11667 Hangzhou | N/A | China | 120.16142 | 30.29365 Nanjing | N/A | China | 118.77778 | 32.06167 Shanghai | N/A | China | 121.45806 | 31.22222 Wuhan | N/A | China | 114.26667 | 30.58333 Xi'an |...
1
NCT00604279
[ 3 ]
22
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens or ketoconazole) for metastatic, androgen-independent prostate cancer.
null
Prostate Cancer
Prostate Cancer
null
1
arm 1: Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
[ 0 ]
1
[ 0 ]
intervention 1: Ruxolitinib 25 mg tablets taken with water twice a day.
intervention 1: Ruxolitinib
15
Highland | California | United States | -117.20865 | 34.12834 Montebello | California | United States | -118.10535 | 34.00946 Mountain View | California | United States | -122.08385 | 37.38605 Galesburg | Illinois | United States | -90.37124 | 40.94782 Overland Park | Kansas | United States | -94.67079 | 38.98223 Wichi...
1
NCT00638378
[ 4 ]
305
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.
Same as above.
Psoriasis
null
1
arm 1: clobetasol propionate spray 0.05% Other Names: Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily calcitriol ointment Other Names: Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
[ 1 ]
2
[ 0, 0 ]
intervention 1: clobetasol propionate spray, 0.05%, applied topically twice daily intervention 2: calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
intervention 1: clobetasol propionate spray 0.05% intervention 2: calcitriol ointment
12
San Diego | California | United States | -117.16472 | 32.71571 Newnan | Georgia | United States | -84.79966 | 33.38067 Snellville | Georgia | United States | -84.01991 | 33.85733 Evansville | Indiana | United States | -87.55585 | 37.97476 New York | New York | United States | -74.00597 | 40.71427 Warren | Ohio | United...
1
NCT00658788
[ 4 ]
588
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.
null
Postoperative Dental Pain
Postoperative Dental Pain
null
5
arm 1: etoricoxib 90 mg arm 2: etoricoxib 120 mg arm 3: ibuprofen 2400 mg arm 4: acetaminophen 2400 mg/codeine 240 mg arm 5: Matching Placebo
[ 0, 0, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: etoricoxib 90 mg; 120 mg (once daily) over three days. intervention 2: ibuprofen 2400 mg (600 mg Q6h) over three Days intervention 3: acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days intervention 4: matching placebo over three Days
intervention 1: Comparator: etoricoxib intervention 2: Comparator: ibuprofen intervention 3: Comparator: acetaminophen + codeine intervention 4: Comparator: placebo
0
null
1
NCT00694369
[ 4 ]
237
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating the pain and other symptoms associated with diabetic peripheral neuropathy.
null
Diabetic Neuropathy, Painful
Diabetic Peripheral Neuropathy
null
1
arm 1: Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
[ 5 ]
1
[ 0 ]
intervention 1: None
intervention 1: Desvenlafaxine Succinate Sustained-Release (DVS SR)
0
null
1
NCT01050218