phases
list
enrollmentCount
int64
allocation
string
interventionModel
string
primaryPurpose
class label
masking
class label
healthyVolunteers
bool
sex
class label
oversightHasDmc
bool
briefSummary
string
detailedDescription
string
conditions
string
conditionsKeywords
string
protocolPdfText
string
numArms
int64
armDescriptions
string
armGroupTypes
list
numInterventions
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interventionNames
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numLocations
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locationDetails
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target
int64
nctid
string
[ 0 ]
1,518
NON_RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisiti...
null
Staphylococcal Infections
Methicillin resistance Infection control Staphylococcus aureus Cross infection Epidemiology Chlorhexidine
null
2
arm 1: Active surveillance cultures (ASC) (via nasal swabs) will be performed for all patients admitted to the medical intensive care unit (ICU) during the designated study period. All patients will be placed in contact isolation until nasal swabs return negative; otherwise will remain in isolation. arm 2: Chlorhexidin...
[ 1, 1 ]
3
[ 10, 0, 10 ]
intervention 1: Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU. intervention 2: CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on ...
intervention 1: Nasal swabs for MRSA culture intervention 2: Chlorhexidine gluconate intervention 3: Contact isolation
1
Newark | Delaware | United States | -75.74966 | 39.68372
0
NCT00779246
[ 5 ]
96
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1. PLEASE NOTE: S...
null
Schizophrenia
Acute schizophrenia PANSS
null
1
arm 1: Seroquel XR 400-800mg
[ 0 ]
1
[ 0 ]
intervention 1: oral, once daily, flexible dose
intervention 1: Quetiapine Fumarate XR
7
Ansan | Gyeonggi-do | South Korea | 127.55845 | 37.21795 Gwangju | Gyeonggi-do | South Korea | 127.25722 | 37.41 Bugok | Gyeongsangnam-do | South Korea | N/A | N/A Masan | Gyeongsangnam-do | South Korea | 128.44938 | 35.35728 Incheon | N/A | South Korea | 126.70515 | 37.45646 Pusan | N/A | South Korea | 128.3681 | 36.3...
0
NCT00779506
[ 4 ]
597
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient D...
Chronic pain from end-stage degenerative joint disease is often moderate to severe in intensity and results in a relatively constant level of pain requiring continuous pain relief medication. Despite available pain relief medications, 60% to 80% of subjects suffering from chronic pain are currently inadequately treated...
Joint Diseases Arthritis Osteoarthritis
Pain medication Arthritis Joint pain Analgesia Analgesics tapentadol CG5503 Nucynta
null
7
arm 1: Tapentadol IR (CG5503) 50mg for 14 days arm 2: Tapentadol IR (CG5503) 75mg for 14 days arm 3: oxycodone IR 10mg for 14 days arm 4: placebo 1 capsule for 14 days arm 5: Tapentadol ER (CG5503) flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day) arm 6: oxycodone CR flexible dose tablets and cap...
[ 0, 0, 1, 2, 0, 1, 2 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day) intervention 2: 10mg for 14 days intervention 3: flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day) intervention 4: 50mg for 14 days intervention 5: 75mg for 14 days intervention 6: 1 capsule for 14 days interve...
intervention 1: oxycodone CR intervention 2: oxycodone IR intervention 3: Tapentadol ER (CG5503) intervention 4: Tapentadol IR (CG5503) intervention 5: Tapentadol IR (CG5503) intervention 6: placebo intervention 7: placebo
0
null
0
NCT00784277
[ 2, 3 ]
6
NON_RANDOMIZED
PARALLEL
null
0NONE
true
1FEMALE
false
PK and safety profile of Proellex® in females with various stages of impaired renal function
The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function
Renal Impairment
Renal impairment
null
3
arm 1: 50 mg Proellex single dose Female subjects with mild renal impairment function. arm 2: 50 mg Proellex, Female subjects with moderate renal impairment function. arm 3: 50 mg Proellex, Female subjects with normal renal function.
[ 1, 1, 1 ]
1
[ 0 ]
intervention 1: Single dose
intervention 1: 50 mg Proellex
4
Miami | Florida | United States | -80.19366 | 25.77427 Orlando | Florida | United States | -81.37924 | 28.53834 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Knoxville | Tennessee | United States | -83.92074 | 35.96064
0
NCT00787618
[ 0 ]
106
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
null
The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic m...
null
Postoperative Pain
Gabapentin PRK pain
null
2
arm 1: oral medication arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Gabapentin 300 mg taken by mouth thrice daily for 7 days intervention 2: placebo (sugar pill) taken by mouth thrice daily for 7 days
intervention 1: Gabapentin intervention 2: placebo
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
0
NCT00793910
[ 3 ]
47
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is a phase II trial of reduced intensity conditioning with Bu/Flu/ATG in pediatric patients with hematologic malignancies at high risk for transplant related mortality with standard transplantation. Patients qualify based on organ system dysfunction, active but stable infection, history of previous transplant or l...
Summary/Proposal: Reduced Intensity Hematopoietic Cell Transplantation for High-Risk Relapsed Pediatric Hematologic Malignancies and Patients Ineligible for Standard Transplantation We propose a phase II trial of reduced intensity conditioning with Bu/Flu/ATG in pediatric patients with hematologic malignancies at high ...
Acute Leukaemia Chronic Disease Leukemia Myelodysplasia Lymphoma
cancer Hematologic Malignancies Hematopoietic Cell Transplantation
null
3
arm 1: Bone Marrow Peripheral Blood Stem Cell (BM PBSC) from a donor related to the participant/recipient arm 2: Bone Marrow Peripheral Blood Stem Cell (BM PBSC) from a donor unrelated to the participant/recipient arm 3: Blood Cord donated from a donor unrelated to the participant/recipient
[ 1, 1, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: This drug is a bifunctional alkylating agent. Busulfan is highly toxic to noncycling or slowly-cycling cells. Pharmacokinetic studies of the IV formulation in pediatrics have shown that using a dose of 0.8mg/kg IV q6 hours most patients will achieve AUC levels between 800 and 1300 uM/min, representing s...
intervention 1: Busulfan intervention 2: Anti-Thymocyte Globulin intervention 3: Fludarabine intervention 4: Cyclosporine intervention 5: Mycophenolate mofetil
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
0
NCT00795132
[ 5 ]
45
NA
SINGLE_GROUP
1PREVENTION
4QUADRUPLE
true
1FEMALE
true
This study is designed to determine the ED90 for an infusion of phenylephrine to prevent spinal induced low blood pressure in parturients presenting for an elective cesarean delivery. The up-down methodology (UDM) is commonly used study method to determine the dose of a drug that causes the desired effect in over 90% o...
null
Spinal Induced Hypotension in Cesarean Delivery
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Up-down, biased coin design
intervention 1: Phenylephrine infusion
0
null
0
NCT00796328
[ 3 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD).
This was a single-center, randomized, double-blind, cross-over, placebo-controlled study. Following screening, each eligible subject was randomized to a dosing sequence. Study subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period. Doses A, B, C, and D were administered in a double...
Chronic Obstructive Pulmonary Disease (COPD)
COPD pulmonary inhalation
null
5
arm 1: Represents Dose A in the Dosing Sequence assignments. arm 2: Represents Dose B arm 3: Represents Dose C arm 4: Represents Dose D arm 5: Represents Dose E. All subjects received Dose E as their final (5th) dose, after completing their initial 4 single doses according to their sequence assignment.
[ 2, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler. intervention 2: Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. intervention 3: Trospium inhalation ...
intervention 1: Placebo intervention 2: TrIP-2D intervention 3: TrIP-2SS intervention 4: TrIP-2D intervention 5: TrIP-2SS + Foradil
1
Spartanburg | South Carolina | United States | -81.93205 | 34.94957
0
NCT00801684
[ 3 ]
78
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to s...
This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in Japanese participants with cancer pain. This study will consist of Screening period (3 to 7 days), Dose adjustment period...
Pain Cancer
Pain Cancer Tapentadol
null
2
arm 1: Opioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in ...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days.
intervention 1: Tapentadol PR
21
Chiba | N/A | Japan | 140.11667 | 35.6 Chikushino-shi | N/A | Japan | 130.5156 | 33.49631 Fukuoka | N/A | Japan | 130.41667 | 33.6 Himeji | N/A | Japan | 134.7 | 34.81667 Hirosaki | N/A | Japan | 140.4725 | 40.59306 Ichinomiya | N/A | Japan | 136.8 | 35.3 Ikeda | N/A | Japan | 135.4298 | 34.82208 Iwakuni | N/A | Japan ...
0
NCT00805142
[ 3 ]
190
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with placebo in a 12-week trial that includes Medical Management. This study is an outpatient study in which approximately 180 alcohol dependent subjects will be enrolled. Subjects will be randomized in a 1:1 fashion to LY686017 or pl...
null
Alcohol Dependence
Alcoholic
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 50 milligrams (mg) daily by oral route for 12 weeks intervention 2: Daily by oral route for 12 weeks
intervention 1: LY686017 intervention 2: Placebo
21
Oceanside | California | United States | -117.37948 | 33.19587 San Diego | California | United States | -117.16472 | 32.71571 Deerfield Beach | Florida | United States | -80.09977 | 26.31841 North Miami | Florida | United States | -80.18671 | 25.89009 Naperville | Illinois | United States | -88.14729 | 41.78586 Indiana...
0
NCT00805441
[ 2, 3 ]
41
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.
null
Chronic Hepatitis C (HCV)
Hepatitis C, HCV, treatment-naive
null
4
arm 1: Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. arm 2: Subjects randomized 8:2 (active:placebo) to receive two ...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: oral dose, active or placebo
intervention 1: IDX184
0
null
0
NCT00807001
[ 3 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed by and additional six courses of induction chemotherapy and then intensification with autologous hematopoietic stem cell ...
All children will receive fixed doses of intravenous temsirolimus (50 mg/m2 weekly 6 times ) concomitantly with two courses of fixed dosages of irinotecan (20 mg/m2 intravenously daily 5 times ,2 days off, repeated daily 5 times .If these initial dosages are not tolerable then subsequent patients will be given a reduce...
Neuroblastoma
Neuroblastoma
null
1
arm 1: Fixed doses of IV temsirolimus concomitantly with two courses of fixed dosages of irinotecan, 2 days off, repeated daily 5 times.If initial dosages are not tolerable, subsequent patients will be given a reduced dosage of temsirolimus with irinotecan.If this dosage combination is not tolerable,irinotecan dosage w...
[ 0 ]
11
[ 0, 0, 3, 0, 0, 0, 0, 0, 3, 4, 0 ]
intervention 1: Temsirolimus intervention 2: Irinotecan intervention 3: Surgical Resection of Primary Tumor intervention 4: Cyclophosphamide intervention 5: Doxorubicin intervention 6: Etoposide intervention 7: Cisplatin intervention 8: Topotecan intervention 9: Peripheral Blood Stem Cell Harvest intervention 10: Radia...
intervention 1: Temsirolimus intervention 2: Irinotecan intervention 3: Surgical Resection of Primary Tumor intervention 4: Cyclophosphamide intervention 5: Doxorubicin intervention 6: Etoposide intervention 7: Cisplatin intervention 8: Topotecan intervention 9: PBSC intervention 10: Radiation Therapy intervention 11: ...
1
Memphis | Tennessee | United States | -90.04898 | 35.14953
0
NCT00808899
[ 5 ]
451
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.
null
Stage 2 Hypertension
Hypertension, aliskiren and valsartan
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks intervention 2: Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks
intervention 1: Valsartan/aliskiren intervention 2: Valsartan
1
East Hanover | New Jersey | United States | -74.36487 | 40.8201
0
NCT00809926
[ 2 ]
12
NON_RANDOMIZED
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
0ALL
false
The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy subjects genotyped for ABCB1, ABCC2, CYP2B6 and UGT1A1.
null
Pharmacokinetics Drug Interactions Pharmacodynamics Intestinal Transporter Expression
null
1
arm 1: A study with a duration of 34 days with 4 periods (= 4 pharmakokinetics) on 12 healthy subjects.
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: administration of 1 tablet/day Ezetrol (10 mg ezetimibe) on study day 6-15 and a pharmakokinetic on study day 15 (0-24 h blood sampling, 0-24 h urine sampling and 5 d feces sampling (study day 11-15)) intervention 2: administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 16-20 and 2 ca...
intervention 1: Ezetrol (ezetimibe) multiple dose intervention 2: Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dose intervention 3: Ezetrol (ezetimibe) and Sustiva (efavirenz) multiple dose intervention 4: Sustiva (efavirenz) single dose
1
Greifswald | N/A | Germany | 13.40244 | 54.08905
0
NCT00810303
[ 3 ]
27
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin
null
Type 2 Diabetes
Type II Diabetes
null
2
arm 1: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days arm 2: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dos...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Subjects will be treated with tolerable dose twice daily for another 24 days. intervention 2: Subjects will be treated with tolerable dose twice daily for another 24 days.
intervention 1: AZD1656 intervention 2: Placebo
1
San Antonio | Texas | United States | -98.49363 | 29.42412
0
NCT00817778
[ 2 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined
null
Congenital Bleeding Disorder Healthy
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 0 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg intervention 2: One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg intervention 3: One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg intervention 4: One single dose is injected i.v. over ...
intervention 1: vatreptacog alfa (activated) intervention 2: vatreptacog alfa (activated) intervention 3: vatreptacog alfa (activated) intervention 4: vatreptacog alfa (activated) intervention 5: placebo intervention 6: placebo intervention 7: placebo intervention 8: placebo
1
Tokyo | N/A | Japan | 139.69171 | 35.6895
0
NCT00822185
[ 0 ]
35
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved. Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at...
Chronic kidney disease (CKD) causes various bone mineral disorders, which have recently been named CKD mineral and bone disorder (CKD-MBD). CKD-MBD presents a spectrum of skeletal abnormalities ranging from high bone turnover state such as osteitis fibrosa, which is seen with SHPT, to states of low bone turnover, which...
Secondary Hyperparathyroidism
null
2
arm 1: Alfacalcidol 1.0 μg capsule by mouth, every day for 6 months arm 2: Alfacalcidol 0.25 μg capsule by mouth, every day for 6 months
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 μg/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy. intervention 2: We compared the efficacy of two protocols for maintenance...
intervention 1: 1.0 μg/day Alfacalcidol intervention 2: 0.25 μg/day Alfacalcidol
1
Kumamoto | Kumamoto | Japan | 130.69181 | 32.80589
0
NCT00828347
[ 4 ]
25
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.
null
Asthma
Asthma Symbicort Turbuhaler
null
2
arm 1: Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days arm 2: Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 160/4.5μg for 3 days intervention 2: 0.4 mg for 3 days
intervention 1: Symbicort Turbuhaler intervention 2: Terbutaline Turbuhaler
2
Ibaraki | N/A | Japan | 135.56828 | 34.81641 Tokyo | N/A | Japan | 139.69171 | 35.6895
0
NCT00837967
[ 3 ]
47
null
CROSSOVER
0TREATMENT
null
false
0ALL
null
The primary objective of the trial is to determine the effect of BI 17444Cl on the lung function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of duration are included: 2 dosages in a once daily a...
null
Pulmonary Disease, Chronic Obstructive
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: BI 1744 CL
5
Genk | N/A | Belgium | 5.50082 | 50.965 Ghent | N/A | Belgium | 3.71667 | 51.05 Hasselt | N/A | Belgium | 5.33781 | 50.93106 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Heerlen | N/A | Netherlands | 5.98154 | 50.88365
0
NCT00846768
[ 3 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus (HCV)-infected participants.
This was a Phase 2a, blinded, randomized, placebo-controlled clinical trial in hepatitis C virus (HCV)-infected adults with 2 planned sequential evaluations, Part 1 and Part 2. The study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-333 or placebo monotherapy, followed by 26 days o...
Chronic Hepatitis C Virus Infection
null
4
arm 1: Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily div...
[ 0, 0, 0, 2 ]
4
[ 0, 10, 0, 0 ]
intervention 1: 50 mg capsules intervention 2: Capsule intervention 3: Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly intervention 4: 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
intervention 1: ABT-333 intervention 2: Placebo for ABT-333 intervention 3: Pegylated interferon intervention 4: Ribavirin
8
Anaheim | California | United States | -117.9145 | 33.83529 Los Angeles | California | United States | -118.24368 | 34.05223 Orlando | Florida | United States | -81.37924 | 28.53834 Baton Rouge | Louisiana | United States | -91.18747 | 30.44332 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Dallas |...
0
NCT00851890
[ 5 ]
207
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidit...
The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction. Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no ro...
Papulopustular Rosacea
Rosacea
null
2
arm 1: Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks arm 2: Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Participants received topical azelaic acid gel 15% twice daily for 12 weeks intervention 2: Participants received topical metronidazole 1% gel once daily for 12 weeks intervention 3: Participants received systemic doxycycline 40 mg once daily for 12 week
intervention 1: Azelaic acid (Finacea, BAY39-6251) intervention 2: Metronidazole (Metrogel) intervention 3: Doxycycline (Oracea)
17
Birmingham | Alabama | United States | -86.80249 | 33.52066 Denver | Colorado | United States | -104.9847 | 39.73915 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Boston | Massachusetts | United States | -71.05977 | 42.35843 Warren | Michigan | United States | -83.01304 | 42.49044 Fridley | Minnesota...
0
NCT00855595
[ 0 ]
135
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer. This is a blinded randomized study. 50% of patients will receive the suppository, 50% of patients will not. Neither you or your sur...
All patients undergoing LRP at Virginia Mason Medical Center between November 1, 2008 and July 30, 2009 were offered the opportunity to participate in a randomized double blind clinical trial. Operating surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients und...
Pain
null
2
arm 1: No suppository given arm 2: B \& O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN)
[ 4, 0 ]
1
[ 0 ]
intervention 1: belladonna 16.2 mg and opium 60 mg suppository
intervention 1: belladonna 16.2 mg and opium 60 mg suppository
1
Seattle | Washington | United States | -122.33207 | 47.60621
0
NCT00863928
[ 3 ]
17
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine. In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study ...
This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.
Pancreas Cancer
pancreas metastatic recurrent
null
1
arm 1: pemetrexed
[ 0 ]
1
[ 0 ]
intervention 1: pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles
intervention 1: pemetrexed
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
0
NCT00864513
[ 3 ]
30
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.
null
Chronic Obstructive Pulmonary Disease (COPD)
COPD Antimuscarinic
null
3
arm 1: Aclidinium bromide 400 μg twice-daily by inhalation arm 2: Tiotropium 18 μg once-daily by inhalation arm 3: Placebo
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days. intervention 2: Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days. intervention 3: Inhaled placebo: 1 puff in ...
intervention 1: Aclidinium bromide 400 μg bid intervention 2: Tiotropium 18 μg once-daily intervention 3: Placebo
2
Berlin | N/A | Germany | 13.41053 | 52.52437 Großhansdorf | N/A | Germany | 10.28333 | 53.66667
0
NCT00868231
[ 2, 3 ]
204
RANDOMIZED
PARALLEL
1PREVENTION
1SINGLE
true
0ALL
false
To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.
null
Upper Gastrointestinal Mucosal Damage
To evaluate the acute gastrointestinal safety of PL-2100.
null
2
arm 1: PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix. arm 2: Immediate release 325mg aspirin
[ 0, 1 ]
1
[ 0 ]
intervention 1: 325mg once a day for 7 days
intervention 1: acetylsalicylic acid
6
Jupiter | Florida | United States | -80.09421 | 26.93422 South Miami | Florida | United States | -80.29338 | 25.7076 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Altoona | Pennsylvania | United States | -78.39474 | 40.51868 Dallas | Texas | United States | -96.80667 | 32.78306 Houston | Texas | Unite...
0
NCT00872534
[ 3 ]
24
RANDOMIZED
PARALLEL
9OTHER
1SINGLE
false
0ALL
false
The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.
null
Psoriasis Vulgaris
null
6
arm 1: LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks arm 2: LEO 29102 cream vehicle applied topically twice daily for 4 weeks. arm 3: Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. arm 4: LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically...
[ 0, 2, 0, 0, 0, 1 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None
intervention 1: LEO 29102 cream intervention 2: LEO 29102 Cream Vehicle intervention 3: Betamethasone Dipropionate Cream intervention 4: LEO 29102 Plus Calcipotriol Cream intervention 5: LEO 29102 Plus Betamethasone Dipropionate intervention 6: Daivobet® Ointment
1
Saint-Quentin-en-Yvelines | N/A | France | 2.01891 | 48.77186
0
NCT00875277
[ 3 ]
241
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.
null
Pain
Phase II Pain
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: oral, during 4 weeks intervention 2: oral, during 4 weeks intervention 3: Oral, during 4 weeks
intervention 1: AZD1386 intervention 2: AZD1386 intervention 3: Placebo
41
Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Bay Roberts | Newfoundland and Labrador | Canada | -53.26478 | 47.59989 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Brampton | Ontario | Canada | -7...
0
NCT00878501
[ 4 ]
1,791
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twi...
Seasonal Allergic Rhinitis
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 2, 1, 1, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Placebo intervention 2: azelastine hydrochloride 548 mg intervention 3: fluticasone propionate 200 mcg intervention 4: azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg
intervention 1: Placebo intervention 2: azelastineHcl intervention 3: fluticasone propionate intervention 4: azelastine Hcl/fluticasone propionate
45
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Encinitas | California | United States | -117.29198 | 33.03699 Fountain Valley | California | United States | -117.95367 | 33.70918 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.0522...
0
NCT00883168
[ 2 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
true
0ALL
false
The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.
null
Healthy Volunteers
Healthy Volunteers
null
4
arm 1: Inhaled PT001 18 μg arm 2: Inhaled PT005 2.4 μg arm 3: Inhaled PT003 (PT001 18 μg / 2.4 μg PT005) arm 4: PT001 18 μg + PT005 2.4 μg
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Inhaled PT001, single dose intervention 2: Inhaled PT005, single dose intervention 3: Inhaled PT003, single dose intervention 4: Inhaled PT001 + PT005, single dose
intervention 1: PT001 intervention 2: PT005 intervention 3: PT003 intervention 4: PT001 + PT005
1
Herston | Queensland | Australia | 153.01852 | -27.44453
0
NCT00893971
[ 5 ]
30
NA
SINGLE_GROUP
9OTHER
0NONE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.
null
P Acnes Colonization
null
1
arm 1: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) Other Names: Epiduo® Gel Apply once daily
[ 0 ]
1
[ 0 ]
intervention 1: Apply once daily
intervention 1: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
1
Broomall | Pennsylvania | United States | -75.35658 | 39.9815
0
NCT00907101
[ 5 ]
52
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated ...
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face wi...
Acne Vulgaris
Acne
null
2
arm 1: Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO). arm 2: Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel. intervention 2: Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxi...
intervention 1: Clindamycin and benzoyl peroxide intervention 2: benzoyl peroxide 2.5% and adapalene 0.1% gel
1
Broomall | Pennsylvania | United States | -75.35658 | 39.9815
0
NCT00926367
[ 5 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
true
This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension.
This was a trial of healthy adults to compare the effects of oral lubiprostone, 24 microgram per day and placebo for three days, on sensation and contractions of the colon using validated methods. On days 1 and 2, participants took the study medication with their breakfast and recorded the time. On day 2 starting at 4...
Healthy
lubiprostone colon motility sensation
null
2
arm 1: Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days. arm 2: Subjects randomized to this arm received placebo medication for three days.
[ 1, 2 ]
3
[ 0, 0, 10 ]
intervention 1: Lubiprostone 24 micrograms, one dose daily for three days in 30 subjects intervention 2: Placebo medication given for three days intervention 3: Polyethylene glycol-based bowel preparation
intervention 1: lubiprostone intervention 2: Placebo intervention 3: Bowel preparation
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
0
NCT00953043
[ 3 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This is a phase II, open label, randomized-controlled pilot study designed to study both the efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is that salsalate will reduce inflammation and ther...
null
HIV Endothelial Dysfunction Inflammation Insulin Resistance
HIV Endothelial dysfunction Inflammation Insulin resistance
null
2
arm 1: None arm 2: None
[ 1, 4 ]
1
[ 0 ]
intervention 1: Salsalate 2 grams orally twice a day for 13 weeks. This is the maximum dosage. During the initial 9 days of the study salsalate dose will be titrated to reach this goal dosage.
intervention 1: Salsalate
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT01046682
[ 4 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This open, multicentric, randomized, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.
This open, multicentric, randomized, controlled study was planned to identify genes activated by hGH in SGA children responders to treatment (making it possible in the near future to better identify SGA children likely to benefit from hGH treatment). Furthermore, the study would hopefully allow to verify which genes we...
Infant, Small for Gestational Age
Infant, small for gestational age Growth hormone Saizen
null
3
arm 1: Participants were allocated to Group A if were still third percentile for height (according to the Tanner reference table) at the age of 4-6 years. Group A would be then randomized to receive Saizen at the daily dose of 0.035 milligram (mg)/kilogram (kg) (Group A1) or no treatment (Group A2) for two years. arm 2...
[ 0, 4, 4 ]
1
[ 0 ]
intervention 1: Recombinant human GH were administered subcutaneously (s.c) at the daily dose of 0.067 mg/kg of body weight to Group A1.
intervention 1: Recombinant human growth hormone (r-hGH)
1
Roma | N/A | Italy | 11.10642 | 44.99364
0
NCT01067352
[ 3 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously\[IV\]) on Day 1 of every 3 week cycle, in combination with fotemustine (100m...
null
Malignant Melanoma
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: 15 mg/kg intravenously on day 1 of every 3 week cycle intervention 2: 100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles
intervention 1: bevacizumab [Avastin] intervention 2: fotemustine
4
Florence | N/A | Italy | 11.24626 | 43.77925 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 12.59836 | 42.78235 Torino | N/A | Italy | 11.99138 | 44.88856
0
NCT01069627
[ 5 ]
125
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.
null
Epilepsy
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Initial dose was 2mg/kg/day, increased after 1\~2 weeks to 3\~4mg/kg/day. intervention 2: Initial dose was 2mg/kg/day, increased after 2\~4 weeks to 6\~8mg/kg/day.
intervention 1: zonisamide low dose group intervention 2: zonisamide high dose group
11
Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.56...
0
NCT01127165
[ 4 ]
168
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatm...
null
Colorectal Cancer
null
1
arm 1: Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
[ 0 ]
2
[ 0, 0 ]
intervention 1: 5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen. intervention 2: Fluoropyrimidine-based chemotherapy administered according to standard of care.
intervention 1: Bevacizumab intervention 2: Fluoropyrimidine-based Chemotherapy
28
Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083 Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083 Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083 Brasília | N/A | Brazil | -47.92972 | -15.77972 Brasília | N/A | Brazil | -47.92972 | -15.77972 Campinas | N/A | Brazil | -47.06083 | -22.90556 Campinas | N/A...
0
NCT01169558
[ 1 ]
95
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
true
The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the body. Laboratory stu...
If you agree to participate in this study you will be asked to undergo a blood test to find out if you are eligible. Approximately 2 tablespoons of blood will be drawn. The blood test will check your health and menopausal status. This test will aslo be used to help measure any additional effects of the study drug on yo...
Breast Cancer
null
2
arm 1: Taken orally, once per day, at/around 9:00pm arm 2: Taken orally, once per day, at/around 9:00pm
[ 1, 2 ]
1
[ 0 ]
intervention 1: Melatonin vs. Placebo
intervention 1: Melatonin 3 mg
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT01805089
[ 2 ]
20
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.
Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study was to consist of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects were to receive a single-dose of 25 mg BIA 9-1067 with a single-dose of racemic 25 mg warf...
Parkinson's Disease (PD)
Parkinson's disease (PD) BIA 9-1067 Opicapone
null
2
arm 1: Period 1: BIA 9-1067 + warfarin Period 2: warfarin arm 2: Period 1: warfarin Period 2: BIA 9-1067 + warfarin
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: BIA 9-1067 25 mg intervention 2: Warfarin 25 mg
intervention 1: BIA 9-1067 intervention 2: Warfarin
1
S. Mamede Do Coronado | Trofa | Portugal | N/A | N/A
0
NCT02169440
[ 5 ]
10
NON_RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantage...
Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.
Asthma
asthma
null
5
arm 1: 0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer arm 2: 0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer arm 3: levalbuterol metered dose inhaler 2 puffs arm 4: levalbuterol MDI + aerochamber max without pause 2 puffs arm 5: levalbuterol MDI + aerochamber max with 2 seco...
[ 1, 1, 1, 1, 1 ]
6
[ 0, 0, 10, 1, 1, 0 ]
intervention 1: 0.5 ml. levalbuterol intervention 2: 0.5ml saline intervention 3: None intervention 4: None intervention 5: None intervention 6: None
intervention 1: levalbuterol intervention 2: saline intervention 3: levalbuterol MDI intervention 4: breath actuated nebulizer intervention 5: aerochamber max intervention 6: ipratroprium
0
null
0
NCT02170532
[ 3 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The study assessed the safety and ability of several doses of an orally inhaled medicine \[ie, Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 ...
In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During...
Chronic Obstructive Pulmonary Disease
Emphysema Chronic bronchitis COPD Chronic Obstructive Pulmonary Disease
null
7
arm 1: Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily arm 2: Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily arm 3: Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily arm 4: Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily ...
[ 0, 0, 0, 0, 0, 0, 2 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: 25 μg oral inhalation via eFlow Nebulizer, once daily intervention 2: 75 μg oral inhalation via eFlow Nebulizer, once daily intervention 3: 200 μg oral inhalation via eFlow Nebulizer, once daily intervention 4: 200 μg oral inhalation via inhalation via jet nebulizer, once daily intervention 5: 500 μg or...
intervention 1: Glycopyrrolate Inhalation Solution 25mg intervention 2: Glycopyrrolate Inhalation Solution 75mg intervention 3: Glycopyrrolate Inhalation Solution 200mg intervention 4: Glycopyrrolate Inhalation Solution 200mg Jet intervention 5: Glycopyrrolate Inhalation Solution 500mg intervention 6: Glycopyrrolate In...
0
null
0
NCT02951312
[ 3 ]
628
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.
null
Essential Hypertension
Essential hypertension Phase 2 study Antihypertensive agent
null
17
arm 1: Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks. arm 2: Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks. arm 3: Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 ...
[ 0, 0, 0, 0, 1, 2, 0, 2, 0, 2, 0, 2, 0, 2, 1, 2, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: LCI699 oral capsules intervention 2: Eplerenone oral capsules intervention 3: LCI699-matching placebo oral capsules intervention 4: Eplerenone-matching placebo oral capsules
intervention 1: LCI699 intervention 2: Eplerenone intervention 3: LCI699-matching Placebo intervention 4: Eplerenone-matching Placebo
1
East Hanover | New Jersey | United States | -74.36487 | 40.8201
0
NCT00758524
[ 2 ]
38
RANDOMIZED
CROSSOVER
9OTHER
0NONE
true
0ALL
null
This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.
null
Healthy
Healthy volunteers
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets intervention 2: CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets. intervention 3: SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).
intervention 1: SPD503 intervention 2: Concerta intervention 3: SPD503 + Concerta
1
Hackensack | New Jersey | United States | -74.04347 | 40.88593
0
NCT00901576
[ 3 ]
49
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.
Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response). The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at le...
Breast Cancer
HER2 positive breast cancer Metastatic breast cancer
null
1
arm 1: Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)
[ 5 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Liposomal Doxorubicin intervention 2: Cyclophosphamide intervention 3: Trastuzumab
12
Badalona | Barcelona | Spain | 2.24741 | 41.45004 Alcorcón | Madrid | Spain | -3.82487 | 40.34582 A Coruña | N/A | Spain | -8.396 | 43.37135 A Coruña | N/A | Spain | -8.396 | 43.37135 Barcelona | N/A | Spain | 2.15899 | 41.38879 Cadiz | N/A | Spain | -6.2891 | 36.52672 Castelló | N/A | Spain | 0.84856 | 41.01149 Jaén |...
0
NCT00258960
[ 3 ]
47
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction.
This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction. Subjects will be invited to complete a screening visit, during which time exercise induced bronchoconstriction must be demonstrated, defined as...
Asthma
Asthma, Exercise Induced Asthma, Exercise Induced Bronchospasm
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 2, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: The current study will include a placebo arm to allow for a valid evaluation of adverse events attributable to GSK2190915 versus those independent of GSK2190915. intervention 2: This study will assess FEV1 at various intervals following exercise challenge in subjects who have been administered a single ...
intervention 1: Placebo intervention 2: GSK2190915
6
Denver | Colorado | United States | -104.9847 | 39.73915 North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Orangeburg | South Carolina | United States | -80.85565 | 33.49...
0
NCT00812929
[ 2 ]
30
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin
null
Healthy Subjects
null
3
arm 1: Vicks Cough immediate-release (IR) syrup 15 mL (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast arm 2: Robitussin Extra Strength Chest Congestion 5 ml (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast arm 3: Or...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water intervention 2: Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water intervention 3: Organ-I- NR tablet (containing 200 mg guaifenesin) with 24...
intervention 1: Vicks Cough Syrup for Chesty Coughs intervention 2: Robitussin Extra Strength Chest Congestion intervention 3: Organ-I- NR tablet
0
null
0
NCT03643575
[ 2 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.
null
End-stage Renal Disease Renal Failure Chronic Requiring Hemodialysis
End-stage renal disease hemodialysis chronic renal failure
null
2
arm 1: 9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session. arm 2: Post dialysis dosing
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: intradialytic: 9 mg/kg during the last 30 minutes of dialysis intervention 2: 6 mg/kg administered after a hemodialysis session
intervention 1: daptomycin intervention 2: daptomycin
2
Cypress | California | United States | -118.03729 | 33.81696 Minneapolis | Minnesota | United States | -93.26384 | 44.97997
0
NCT00882557
[ 4 ]
302
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort
null
Abdominal Pain
null
2
arm 1: None arm 2: None
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Hyoscine Butylbromide - Tablet intervention 2: Hyoscine Butylbromide - Capsule intervention 3: Placebo
0
null
0
NCT02242305
[ 2 ]
12
RANDOMIZED
CROSSOVER
2DIAGNOSTIC
2DOUBLE
true
2MALE
false
This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.
null
Type 2 Diabetes Mellitus
null
3
arm 1: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods arm 2: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods arm 3: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test. intervention 2: Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.
intervention 1: sitagliptin intervention 2: Comparator: Placebo
0
null
0
NCT00888238
[ 4 ]
147
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week...
null
Pulmonary Disease, Chronic Obstructive
null
4
arm 1: 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)/ 18 µg Tiotropium (Tio18GEL) / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (T18GEL) plus 50 µg Salmeterol MDPI (S\_DPI) BID arm 2: 18 µg Tiotropium (Tio18GEL) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 7.5 µg/ 25 µg Tiotropium/Salmete...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 18 µg Tiotropium (Tio18GEL) inhalation powder intervention 2: 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID) intervention 3: 18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID) intervention 4: Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmetero...
intervention 1: Tiotropium (Tio18GEL) intervention 2: Salmeterol MDPI (Salm50DPI) intervention 3: Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI) intervention 4: Tiotropium/Salmeterol (T+S_PE)
12
Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Cottbus | N/A | Germany | 14.32888 | 51.75769 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Hamburg | N/A | Germany | 9.99302 | 53.55073 Mainz | N/A | Germany | 8.2791 | 49.98419 Mannheim | N/A | Germany | 8.46694 | 49.4891 R...
0
NCT00662792
[ 3 ]
81
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.
null
Psoriasis
chronic plaque psoriasis topical treatment
null
8
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
[ 0, 0, 0, 0, 0, 0, 2, 2 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Topical treatment once daily for 28 days intervention 2: Topical treatment once daily for 28 days intervention 3: Topical treatment once daily for 28 days intervention 4: Topical treatment twice daily for 28 days intervention 5: Topical treatment twice daily for 28 days intervention 6: Topical treatment...
intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550 intervention 6: CP-690,550 intervention 7: Placebo Vehicle intervention 8: Placebo Vehicle
20
Irvine | California | United States | -117.82311 | 33.66946 San Diego | California | United States | -117.16472 | 32.71571 Chicago | Illinois | United States | -87.65005 | 41.85003 Boston | Massachusetts | United States | -71.05977 | 42.35843 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Fridley | Minneso...
0
NCT00678561
[ 3 ]
169
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumo...
OBJECTIVES: Primary * To measure the progression-free survival of patients with metastatic or unresectable melanoma with no brain metastasis or no prior treatment with temozolomide (TMZ) treated with sorafenib tosylate in combination with two different schedules (extended daily dosing vs standard dosing) of TMZ. * To...
Melanoma (Skin)
recurrent melanoma stage III melanoma stage IV melanoma
null
4
arm 1: Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. arm 2: Patients who were temozolomide naive and had no brain metastases re...
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Given orally intervention 2: Given orally
intervention 1: sorafenib tosylate intervention 2: temozolomide
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00602576
[ 2 ]
42
RANDOMIZED
CROSSOVER
9OTHER
0NONE
true
0ALL
null
Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.
null
Healthy
Normal, healthy volunteers (for this Phase 1 study)
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day...
intervention 1: SPD503 intervention 2: VYVANSE intervention 3: SPD503 and VYVANSE
1
Hackensack | New Jersey | United States | -74.04347 | 40.88593
0
NCT00919867
[ 3 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This phase II clinical trial is studying biomarkers and side effects in women receiving chemotherapy and cele...
OBJECTIVES: * To determine the safety and efficacy of four courses of neoadjuvant chemotherapy comprising docetaxel, capecitabine, and celecoxib followed by doxorubicin hydrochloride, cyclophosphamide, and celecoxib for the treatment of women with resectable stage II or III breast cancer. * To determine the mRNA and p...
Breast Cancer
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
null
1
arm 1: •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive dox...
[ 0 ]
19
[ 2, 0, 0, 0, 0, 0, 6, 6, 6, 6, 10, 10, 10, 10, 3, 3, 3, 3, 3 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None intervention 14: None intervention 15: None...
intervention 1: filgrastim intervention 2: capecitabine intervention 3: celecoxib intervention 4: cyclophosphamide intervention 5: docetaxel intervention 6: doxorubicin hydrochloride intervention 7: gene expression analysis intervention 8: polymorphism analysis intervention 9: protein expression analysis intervention 1...
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
0
NCT00665457
[ 2 ]
41
RANDOMIZED
CROSSOVER
9OTHER
0NONE
true
0ALL
null
To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)
null
Healthy
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. intervention 2: Lanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. intervention 3: Sevelamer carbona...
intervention 1: Calcitriol intervention 2: Lanthanum carbonate + Calcitriol intervention 3: Sevelamer carbonate + Calcitriol
1
Cypress | California | United States | -118.03729 | 33.81696
0
NCT00925704
[ 5 ]
200
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.
To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25\~27 weeks.
Epilepsy
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day. intervention 2: Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
intervention 1: zonisamide intervention 2: carbamazepine
12
Bundang | N/A | South Korea | N/A | N/A Ilsan | N/A | South Korea | 129.43333 | 35.5 Incheon | N/A | South Korea | 126.70515 | 37.45646 Jungnam | N/A | South Korea | 128.02522 | 36.27333 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37...
0
NCT01127256
[ 3 ]
304
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiven...
CF is an inherited disease that causes mucus to build up in the lungs and digestive tract, which can cause lung infections and digestive problems. It is the most common type of chronic lung disease in children and young adults and may result in early death. There is no cure for this disease. The primary cause of death ...
Cystic Fibrosis Pulmonary Disease, Chronic Obstructive
Lung Diseases Chronic Obstructive Pulmonary Disease
null
4
arm 1: Tobramycin inhalation solution and oral placebo for six consecutive quarterly cycles arm 2: Tobramycin solution for inhalation and oral ciprofloxacin for six consecutive quarterly cycles. arm 3: Tobramycin solution for inhalation and oral placebo administered only when quarterly respiratory cultures are found po...
[ 2, 1, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Tobramycin solution for inhalation, 300 mg, administered twice daily for 28 days administered only when quarterly respiratory cultures are found positive for Pa. intervention 2: Oral placebo for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants wi...
intervention 1: Tobramycin solution for inhalation (TOBI) intervention 2: Oral placebo intervention 3: Oral ciprofloxacin
54
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Palo Alto | California | United States | -122.14302 | 37.44188 San Francisco | California | United States | -122.41942 | 37.77493 Auror...
1
NCT00097773
[ 4 ]
1,286
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the cl...
null
Rheumatoid Arthritis
null
3
arm 1: In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (D...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months. intervention 2: During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept t...
intervention 1: Abatacept intervention 2: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD) intervention 3: Anti-Tumor Necrosing Factor (TNF) Therapy
148
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Paradise Valley | Arizona | United States | -111.94265 | 33.53115 Peoria | Arizona | United States | -112.23738 | 33.5806 Tucson | Arizona | United States | -110.92648 | 32.22174 Long Beach | Californi...
1
NCT00124982
[ 4 ]
708
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify t...
null
Diabetes Diabetes Mellitus, Type 2
null
3
arm 1: Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the s...
[ 0, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart intervention 2: Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart interven...
intervention 1: biphasic insulin aspart intervention 2: insulin detemir intervention 3: insulin aspart
63
Dublin | N/A | Ireland | -6.24889 | 53.33306 Dublin | N/A | Ireland | -6.24889 | 53.33306 Dublin | N/A | Ireland | -6.24889 | 53.33306 Galway | N/A | Ireland | -9.05095 | 53.27245 Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369 Addlestone | N/A | United Kingdom | -0.49353 | 51.37135 Airdrie | N/A | United Kingdom...
1
NCT00184600
[ 4 ]
919
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
1FEMALE
true
This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction the...
This study (Study B9E-US-S302) is a multicenter, comparative, open-label randomized, superiority, trial evaluating Gemcitabine and Carboplatin to the standard of care. Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mg/m\^2 given every 28 days for one year. Patie...
Genital Neoplasms, Female Fallopian Tube Neoplasms Ovarian Neoplasms Pelvic Neoplasms Peritoneal Neoplasms
null
2
arm 1: Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles arm 2: Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 1000 mg/m\^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles If anything other than complete response in Paclitaxel arm patients, 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity intervention 2: 175 mg/m\^2, IV, Day 1, q...
intervention 1: Gemcitabine intervention 2: Paclitaxel intervention 3: Carboplatin
55
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Los Gatos | California | United States | -121.97468 | 37.22661 Modesto | California | United States | -120.99688 | 37.6391 San Diego | California | United States | -117.16472 | 32.71571 Englewood | Co...
1
NCT00191646
[ 4 ]
9,016
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.
ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events. Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel: * ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone * AC...
Atrial Fibrillation Cardiovascular Disease
Atrial fibrillation Cardiovascular disease angiotensin II blocker
null
2
arm 1: 150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit arm 2: Matching placebo up to final follow-up visit
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: oral administration (tablets) once daily intervention 2: oral administration (tablets) once daily
intervention 1: Irbesartan intervention 2: placebo
30
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Macquarie Park | N/A | Australia | 151.12757 | -33.78105 Vienna | N/A | Austria | 16.37208 | 48.20849 Diegem | N/A | Belgium | 4.43354 | 50.89727 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Laval |...
1
NCT00249795
[ 2 ]
69
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.
null
HIV Infection
HIV-1 infected pregnant women, either treatment naive or on ATV/RTV combined with ZDV/3TC
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks
intervention 1: Atazanavir + Ritonavir + Combivir
6
West Palm Beach | Florida | United States | -80.05337 | 26.71534 Houston | Texas | United States | -95.36327 | 29.76328 San Juan | N/A | Puerto Rico | -66.10572 | 18.46633 Soweto | Gauteng | South Africa | 27.85849 | -26.26781 Sunnyside | Gauteng | South Africa | 28.21133 | -25.75746 Westdene | Gauteng | South Africa |...
1
NCT00326716
[ 3 ]
486
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer ad...
null
Severe Sepsis
null
3
arm 1: 24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours arm 2: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol) arm 3: 24 mcg/kg/hr for 24 hours, followed ...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: intravenous
intervention 1: Drotrecogin alfa (activated)
47
Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Fresno | California | United States | -119.77237 | 36.74773 Loma Linda | California | United States | -117.26115 | 34.04835 Stanford | California | United States | -122.16608 | 37.42411 Washington D.C....
1
NCT00386425
[ 4 ]
1,200
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
null
Chronic Obstructive Pulmonary Disease
COPD
null
0
null
null
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Budesonide/formoterol (SYMBICORT) pMDI intervention 2: Formoterol Turbuhaler
140
Jasper | Alabama | United States | -87.27751 | 33.83122 Mobile | Alabama | United States | -88.04305 | 30.69436 Tucson | Arizona | United States | -110.92648 | 32.22174 Fort Smith | Arkansas | United States | -94.39855 | 35.38592 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Anaheim | California | Unite...
1
NCT00419744
[ 4 ]
64
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. In this study patients and physicians know the name and the dose of the study drug. Newly diagnosed patients will also be inclu...
This trial is a non-randomised (both patient and physician know the study drug), single arm, open label multicentre study which is aimed to evaluate the dose distribution, efficacy and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. Newly diagnosed patients...
Schizophrenia
Schizophrenia Drug Therapy Treatment Outcome
null
1
arm 1: Paliperidone3mg or 6mg or 9mg or 12mg once daily for 52 weeks
[ 0 ]
1
[ 0 ]
intervention 1: 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
intervention 1: Paliperidone
0
null
1
NCT00473434
[ 5 ]
593
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
null
Smoking Cessation
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 1 mg twice a day for 12 weeks, starting with a 1-week titration period. intervention 2: matching placebo 1 tablet twice a day for 12 weeks
intervention 1: varenicline tartrate (CP-526, 555-18) intervention 2: Placebo
42
Fortaleza | Ceará | Brazil | -38.54306 | -3.71722 Porto Alegre | Centro | Brazil | -51.23019 | -30.03283 Juiz de Fora | Minas Gerais | Brazil | -43.35028 | -21.76417 Botucatu | São Paulo | Brazil | -48.445 | -22.88583 São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 São Paulo | São Paulo | Brazil | -46.63611 | -23...
1
NCT00594204
[ 3 ]
197
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.
null
Psoriasis
dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: tablets, 2 mg BID for 12 weeks intervention 2: tablets, 5 mg BID for 12 weeks intervention 3: tablets, 15 mg BID for 12 weeks intervention 4: tablets, BID for 12 weeks
intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo
44
Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Oceanside | California | United States | -117.37948 | 33.19587 Jacksonville | Florida | United States | -81.65565 | 30.33218 Miami | Florida | United States | -80.19366 | 25.77427 West Dundee | Illinoi...
1
NCT00678210
[ 4 ]
1,291
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to placebo, valsartan and olmesartan in participants with essential hypertension.
Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause ...
Hypertension
Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 1, 1, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks. Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks. intervention 2: Azilsartan medoxomil 40 mg, tablets and matching placebo comparat...
intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil intervention 3: Valsartan intervention 4: Olmesartan intervention 5: Placebo
131
Alabaster | Alabama | United States | -86.81638 | 33.24428 Ozark | Alabama | United States | -85.64049 | 31.45906 Green Valley | Arizona | United States | -110.9937 | 31.85425 Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Mesa | Arizona | United States | -111.82264 | 33.42227 Tempe | Arizona | Unite...
1
NCT00696436
[ 4 ]
688
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherap...
The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy ...
Major Depressive Disorder Treatment Resistant Depression
Depression MDD TRD
null
3
arm 1: Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od). From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline. arm 2: Selective serotonin reuptake inhibitors (SSRI)...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 300 mg once daily (od) intervention 2: 900 mg once daily (od) intervention 3: SSRI - doses within label, Venlafaxine dose up to 225 mg/day
intervention 1: Quetiapine XR intervention 2: Lithium carbonate intervention 3: SSRI/Venlafaxine
106
Garran | Australian Capital Territory | Australia | 149.10846 | -35.34206 Brisbane | Queensland | Australia | 153.02809 | -27.46794 Everton Park | Queensland | Australia | 152.9884 | -27.40732 Townsville | Queensland | Australia | 146.80569 | -19.26639 Gilberton | South Australia | Australia | 138.6126 | -34.90051 Clay...
1
NCT00789854
[ 3 ]
188
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will test the effectiveness of an experimental treatment for peritoneal cancer involving surgical removal of the tumor, perfusion of the abdomen during surgery with a heated solution of the drug cisplatin, and post-surgery combination chemotherapy in the abdomen with fluorouracil (5-FU) and paclitaxel. Pati...
Background: Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of peritoneal carcinomatosis. The purpose of this study is to examine the treatment results of continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin plus early postoperati...
Abdominal Neoplasm Colonic Neoplasm Mesothelioma Peritoneal Neoplasm
Surgery Mesothelioma Pseudomyxoma Colon Cancer Chemotherapy
null
3
arm 1: Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites. arm 2: Low grade mucinous adenocarcinoma also includes low gra...
[ 0, 0, 0 ]
3
[ 3, 3, 0 ]
intervention 1: Patients will undergo cytoreductive surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected. intervention 2: None intervention 3: Intraperitoneal dwell chemotherapy with a combination of 5-FU and Paclitaxel will...
intervention 1: Surgery intervention 2: Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin intervention 3: Postoperative dwell with paclitaxel and 5-FU
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00004547
[ 3 ]
94
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may ...
OBJECTIVES: * Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms of objective response rate, in patients with metastatic adenocarcinoma of the pancreas. * Determine the time to progression and overall survival of patients treated with these regimens. * Determine the proportion of pa...
Pancreatic Cancer
pancreatic cancer metastatic pancreatic cancer EGF-r irinotecan docetaxel cetuximab
null
2
arm 1: Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (da...
[ 1, 0 ]
3
[ 2, 0, 0 ]
intervention 1: Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks. intervention 2: Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was di...
intervention 1: cetuximab intervention 2: docetaxel intervention 3: irinotecan hydrochloride
0
null
0
NCT00042939
[ 3 ]
72
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop ...
PRIMARY OBJECTIVES: I. To assess overall survival in patients with limited stage small cell lung cancer (SCLC) treated with induction tirapazamine combined with cisplatin, etoposide and high dose thoracic radiotherapy followed by consolidative cisplatin and etoposide. II. To assess time to treatment failure calculate...
Limited Stage Small Cell Lung Cancer
null
1
arm 1: CHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for ...
[ 0 ]
5
[ 0, 0, 0, 4, 10 ]
intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Undergo radiation therapy intervention 5: Correlative studies
intervention 1: tirapazamine intervention 2: cisplatin intervention 3: etoposide intervention 4: radiation therapy intervention 5: laboratory biomarker analysis
1
San Antonio | Texas | United States | -98.49363 | 29.42412
0
NCT00066742
[ 3 ]
24
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor.
OBJECTIVES: * Determine response (confirmed, complete, and partial) in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Correlate, preliminarily, indicators of epide...
Sarcoma
adult neurofibrosarcoma stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage II adult soft tissue sarcoma stage IV adult soft tissue sarcoma
null
1
arm 1: Drug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression
[ 0 ]
1
[ 0 ]
intervention 1: 150 mg per day, daily until disease progression
intervention 1: erlotinib hydrochloride
101
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Davis | California | United States | -121.74052 | 38.54491 Martinez | California | United States | -122.13413 | 38.01937 Denver | Colorado | United States | -104.9847 | 39.73915 Denver | Colorado | United States | -104.9847 | 39.73915 Montrose | Colorado | U...
0
NCT00068367
[ 3 ]
62
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This phase II trial studies how well temsirolimus works in treating patients with endometrial cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and has come back after a period of time during which the cancer could not be detected. Temsirolimus may sto...
PRIMARY OBJECTIVES: I. To assess the efficacy (response rate \& duration of stable disease) of CCI-779 (temsirolimus) given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. II. To assess the adverse events, time to progression and response duration ...
Endometrial Adenocarcinoma Endometrial Adenosquamous Cell Carcinoma Endometrial Clear Cell Carcinoma Endometrial Papillary Serous Carcinoma Recurrent Endometrial Carcinoma Stage IIIA Endometrial Carcinoma Stage IIIB Endometrial Carcinoma Stage IIIC Endometrial Carcinoma Stage IVA Endometrial Carcinoma Stage IVB Endomet...
null
1
arm 1: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 10 ]
intervention 1: Given IV intervention 2: Correlative studies
intervention 1: temsirolimus intervention 2: laboratory biomarker analysis
1
Kingston | Ontario | Canada | -76.48098 | 44.22976
0
NCT00072176
[ 3 ]
155
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity
null
Stroke Muscle Spasticity Motor Neuron Disease
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 2, 2, 0 ]
intervention 1: botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18 intervention 2: botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18 intervention 3: Saline injection at Day 1, Week 12, Week 18
intervention 1: botulinum toxin Type A intervention 2: botulinum toxin Type A intervention 3: saline
4
Miami | Florida | United States | -80.19366 | 25.77427 Prague | N/A | Czechia | 14.42076 | 50.08804 Szeged | N/A | Hungary | 20.14824 | 46.253 Warsaw | N/A | Poland | 21.01178 | 52.22977
0
NCT00076687
[ 3 ]
11
RANDOMIZED
CROSSOVER
9OTHER
4QUADRUPLE
false
0ALL
true
This study examines if Yohimbine, when given during the sleep cycle, will improve symptoms of depression within a matter of hours. Purpose: This study will examine whether the drug yohimbine, given at a specific time during the sleep cycle, produces chemical changes in the brain similar to those that occur with sleep ...
Sleep deprivation is one of the only interventions that have consistently been demonstrated to produce rapid antidepressant effects. The mechanisms by which sleep deprivation brings about rapid antidepressant effects remain to be elucidated. It is noteworthy, however, that recent genomic and proteomic studies have show...
Depression, Involutional Major Depresssion
Yohimbine Sleep Deprivation Depression Mood Disorder Fast Affective Disorder Rapid Onset Major Depression MDD
null
2
arm 1: Participants are randomized to receive yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep. After 8 days they receive placebo administered over 3 minutes during REM sleep. arm 2: Participants are randomized to receive placebo administered over 3 minutes during REM sleep. After 8 days they receive ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Participants receive yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep. intervention 2: Participants receive an inactive equivalent of yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep.
intervention 1: Yohimbine hydrochloride intervention 2: Placebo
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00078715
[ 3 ]
112
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well ...
OBJECTIVES: * Determine the response rate (complete and partial, confirmed and unconfirmed) in women with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine. * Determine the progression-free survival and overall survival of patients treated with this regimen. * Determine the toxicity of th...
Breast Cancer
stage IV breast cancer recurrent breast cancer
null
1
arm 1: cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
[ 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: capecitabine intervention 2: cyclophosphamide
145
Anchorage | Alaska | United States | -149.90028 | 61.21806 Anchorage | Alaska | United States | -149.90028 | 61.21806 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Castro Valley | California | United States | -122.08635 | 37.6941 Fremont | California | United States | -121.98857 | 37.54827 Hayward | Cal...
0
NCT00107276
[ 0 ]
42
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Primary Objectives: 1. To evaluate clinical tolerance and response to curcumin alone and in combination with Bioperine in patients with multiple myeloma. 2. To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin + Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin....
Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. Bioperine is a pepper extract that increases the absorption of nutrient supplements. In this study, 6 patients at a t...
Multiple Myeloma
Multiple Myeloma Diferuloylmethane Derivative Curcumin Bioperine
null
2
arm 1: Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.). arm 2: Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 2 grams (Capsules) orally in 2 divided doses (a.m., p.m.) intervention 2: 5 mg (Tablets) orally twice daily
intervention 1: Curcumin intervention 2: Bioperine
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00113841
[ 2, 3 ]
112
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.
This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy. Nanoparticle paclitaxel was administered by intracoronary catheter following either successful and uncomplicated stenting of de novo lesions ...
Coronary Restenosis
Prevention of Instent Restenosis
null
4
arm 1: Participants received a single dose of 10 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions). arm 2: Participants received a single dose of 22 m...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.
intervention 1: Nanoparticle Paclitaxel
0
null
0
NCT00124943
[ 3 ]
400
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
true
2MALE
true
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
This study will assess the clinical and behavioral safety and tolerability of oral daily TDF use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in uninfected men.
HIV Infection
null
4
arm 1: participants in this arm start study product immediately upon enrollment arm 2: participants in this arm start study product immediately upon enrollment arm 3: persons in this arm start study product 9 months after enrollment arm 4: participants in this arm start study product nine months after enrollment
[ 1, 2, 1, 2 ]
2
[ 0, 0 ]
intervention 1: study product taken daily intervention 2: study product taken daily
intervention 1: tenofovir disoproxil fumarate intervention 2: placebo
3
San Francisco | California | United States | -122.41942 | 37.77493 Atlanta | Georgia | United States | -84.38798 | 33.749 Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00131677
[ 3, 4 ]
321
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery. This study involves two concurrent double-blinded randomized clinical trials of 17...
Prematurity is a leading cause of neonatal morbidity and mortality in the USA. Nationally, 12% of all babies deliver before term and 3% deliver before 32 wks gestational age (GA). Recent studies suggest that 17OHP and other progesterone derivatives may reduce the rate of preterm birth among women with a history of prio...
Preterm Birth
Preterm Birth Preterm Delivery Multiple gestation 17-alpha-hydroxyprogesterone caproate Progesterone
null
2
arm 1: Test Group will receive weekly doses of 170HP via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. arm 2: Control Group will receive weekly doses of placebo (NS) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first. intervention 2: Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or ...
intervention 1: 17-alpha-hydroxyprogesterone caproate injectable intervention 2: Placebo
18
Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Laguna Hills | California | United States | -117.71283 | 33.61252 Long Beach | California | United States | -118.18923 | 33.76696 Orange | California | United States | -117.85311 | 33.78779 San Jose | Cali...
0
NCT00163020
[ 5 ]
319
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.
The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication al...
Depression
Elderly Remission Escitalopram Interpersonal Psychotherapy Psychotherapy Caregiving Late-Life
null
2
arm 1: Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT) arm 2: Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension thera...
[ 0, 1 ]
3
[ 0, 5, 5 ]
intervention 1: Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks. intervention 2: 16 sessions of interpersonal psychotherapy (IPT) intervention 3: 16 weeks of depression care management(DCM). No psychotherapy will be provided.
intervention 1: Escitalopram intervention 2: Interpersonal Psychotherapy intervention 3: Clinical Monitoring
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
0
NCT00177294
[ 4 ]
228
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).
null
Attention Deficit Hyperactivity Disorder
null
1
arm 1: 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
[ 0 ]
1
[ 0 ]
intervention 1: 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
intervention 1: Atomoxetine hydrochloride
24
Aichi | N/A | Japan | 130.62158 | 32.51879 Chiba | N/A | Japan | 140.11667 | 35.6 Fukui | N/A | Japan | 135.54836 | 34.84214 Fukuoka | N/A | Japan | 130.41667 | 33.6 Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Ibaraki | N/A | Japan | 135.56828 | 34.81641 Ishikawa | N/A | Japan | 127.82...
0
NCT00191386
[ 3 ]
41
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combin...
Upon determination of eligibility, all patients will be receive: Gemcitabine + Trastuzumab
Breast Cancer
null
1
arm 1: All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on ...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Trastuzumab intervention 2: Gemcitabine
intervention 1: Trastuzumab intervention 2: Gemcitabine
0
null
0
NCT00193063
[ 3 ]
72
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced N...
Upon determination of eligibility, patients will be receive: * Pemetrexed + Gemcitabine
Lung Cancer
null
1
arm 1: Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
[ 0 ]
2
[ 0, 0 ]
intervention 1: 500mg/m2 IV over 10 min, Day 1, prior to gemcitabine intervention 2: 1500mg/m2, 30min IV
intervention 1: Pemetrexed intervention 2: Gemcitabine
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
0
NCT00193414
[ 3 ]
22
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
true
We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is de...
Osteoporosis is an uncommon disease in children and early adolescents. Patients have a low bone mineral density, develop fractures with minimal or no trauma, and frequently have a negative family history. The disease results from either diminished bone formation or increased bone removal (resorption). No specific drug ...
Osteoporosis
Fracture Bone Mineral Density DXA
null
2
arm 1: Crossover study. Year-1, 10 participants will take study medication, calcium and vitamin D supplements and other 10 participants will take placebo, calcium and vitamin D supplements. Year-2, they will crossover to the second arm of the study. Those who took study medication and supplements in year-1, will take p...
[ 0, 2 ]
1
[ 0 ]
intervention 1: Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, dependi...
intervention 1: Alendronate
1
Charleston | South Carolina | United States | -79.93275 | 32.77632
0
NCT00259857
[ 3 ]
45
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to control CLL in patients who have already received standard therapy. The safety of lenalidomide will also be studied.
Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. Before you can start treatment on this study, you will have what are called "screeni...
Chronic Lymphocytic Leukemia Leukemia
Chronic Lymphocytic Leukemia Lenalidomide Revlimid CLL
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 10 mg/day, orally once a day for 28 days
intervention 1: Lenalidomide
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00267059
[ 2, 3 ]
30
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.
null
Acute Ischemic Stroke
Stroke Nonhemorrhagic hypothermia
null
0
null
null
2
[ 0, 3 ]
intervention 1: Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours. intervention 2: External or internal cooling for 24 hours and rewarming over 12 hours.
intervention 1: Caffeinol intervention 2: hypothermia
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00299416
[ 4 ]
895
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock. Injury and lost blood from trauma can cause your body to be in shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In o...
Specific Aim: To determine if prehospital administration of 7.5% hypertonic saline /6% Dextran-70 (HSD) OR 7.5% hypertonic saline alone (HS), compared to current standard therapy with normal saline (NS), as an initial resuscitation fluid, affects survival following traumatic injury with hypovolemic shock. Trauma is th...
Shock, Traumatic
Trauma Shock
null
3
arm 1: 7.5% hypertonic saline/6% Dextran-70 (HSD) arm 2: 7.5% hypertonic saline (HS) arm 3: 0.9% normal saline
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting. intervention 2: 250 cc dose given as a one-time IV bolus in the pre-hospital setting. intervention 3: 250 cc dose given as a one-time IV bolus in the pre-hospital setting.
intervention 1: 7.5% hypertonic saline/6% Dextran-70 (HSD) intervention 2: 7.5% hypertonic saline (HS) intervention 3: 0.9% normal saline
10
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Diego | California | United States | -117.16472 | 32.71571 Iowa City | Iowa | United States | -91.53017 | 41.66113 Portland | Oregon | United States | -122.67621 | 45.52345 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Dallas | Texas | U...
0
NCT00316017
[ 5 ]
288
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving v...
A decision was made by the sponsor (08 May 2009) to terminate this study early; the study had achieved the primary objective prior to termination. This study was not terminated due to safety reasons.
Age Related Macular Degeneration (AMD) Macular Degeneration Choroidal Neovascularization (CNV)
neovascular age related macular degeneration choroidal neovascularization
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Pegaptanib Sodium dosed every 6 weeks in affected eye.
intervention 1: Pegaptanib Sodium 0.3 mg
58
Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Liège | N/A | Belgium | 5.56749 | 50.63373 Victori...
0
NCT00327470
[ 4 ]
111
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The objective of this study is to evaluate the safety of long-term treatment with Phenoptin in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with Phenoptin.
null
Phenylketonuria
PKU
null
0
null
null
1
[ 0 ]
intervention 1: 5-20mg/kg/day orally, dose may be adjusted up or down as needed at the discretion of the investigator in increments of 5mg/kg/day.
intervention 1: sapropterin dihydrochloride
14
Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 San Jose | California | United States | -121.89496 | 37.33939 New Haven | Connecticut | United States | -72.92816 | 41.30815 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Il...
0
NCT00332189
[ 4 ]
1,771
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).
null
Asthma
null
3
arm 1: Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period arm 2: Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period arm 3: Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period. intervention 2: Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period. intervention 3: Pbo qd + episode driven supplemental Mont...
intervention 1: montelukast sodium intervention 2: Comparator: Placebo (unspecified) intervention 3: montelukast sodium
0
null
0
NCT00337675
[ 4 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.
Decreases in physical abilities, including losses of strength, endurance, balance, and coordination are major causes of disability and loss of independence in older men. Such individuals are at high risk for injurious falls, hospitalization, and use of supportive services. Age-associated testosterone deficiency may con...
Physical Frailty Hip Fracture Elective Hip Replacement Hypogonadism
Testosterone Replacement Therapy Physical Frailty Hip Fracture
null
2
arm 1: Transdermal testosterone 1% gel (Androgel) provided as 2.5 gm and/or 5 gm gel packets with dose titration and monthly dose adjustments to achieve and maintain serum total testosterone level between 500-900 mg/dL. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets...
[ 1, 2 ]
2
[ 0, 5 ]
intervention 1: Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl. intervention 2: Supervised exercise training performed on site at academic medical center exercise facility. Exe...
intervention 1: Transdermal Testosterone gel (1%) intervention 2: Supervised exercise training
1
St Louis | Missouri | United States | -90.19789 | 38.62727
0
NCT00345969
[ 3 ]
90
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.
Acute lung injury (ALI) is common among critically ill patients and is associated with a high case fatality. Only one intervention has been shown to improve survival in a large clinical trial, and new therapies targeting the inflammatory response are needed. Nutrient interventions may provide benefit; specifically ther...
Respiratory Distress Syndrome, Adult Acute Lung Injury Acute Respiratory Distress Syndrome
Respiratory distress syndrome, adult Acute lung injury Acute respiratory distress syndrome ARDS, human Fish oils Fatty Acids, Omega-3 Docosahexaenoic Acids Eicosapentaenoic Acid
null
2
arm 1: Enteral fish oil arm 2: Enteral saline
[ 0, 2 ]
1
[ 0 ]
intervention 1: Liquid fish oil 7.5cc enterally every 6 hours
intervention 1: Fish oil (eicosapentaenoic acid and docosahexanoic acid)
5
Boise | Idaho | United States | -116.20345 | 43.6135 Portland | Oregon | United States | -122.67621 | 45.52345 Burlington | Vermont | United States | -73.21207 | 44.47588 Seattle | Washington | United States | -122.33207 | 47.60621 Toronto | Ontario | Canada | -79.39864 | 43.70643
0
NCT00351533
[ 5 ]
200
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
true
The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA). The investigators hypothesize that treatment with cephalexin, a penicillin-like antibiotic to which CA-MRSA would be exp...
Community-associated methicillin resistant Staphylococcus Aureus (CA-MRSA) infections have increased significantly over the past decade. Nearly every major region of the country has reported infections with this organism, with some areas reporting a prevalence as high as 80%. Epidemiologic evidence points to the emerge...
Staphylococcal Infection Abscess Staphylococcal Skin Infection Folliculitis
clinical trial randomized blinded controlled
null
2
arm 1: None arm 2: None
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days intervention 2: cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days
intervention 1: clindamycin intervention 2: cephalexin
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
NCT00352612
[ 0 ]
1,767
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Approximately 2 million Ontarians are current smokers. While smoking rates have declined over the past 25 years, these rates have remained constant since 2002. The rate of smoking cessation in Ontario has not kept up with the rest of Canada. A new strategy is necessary to increase the number of smokers making quit atte...
According to the US Surgeon General's Report (1988), there are immediate, intermediate and long-term benefits to health from quitting smoking. For example, there is a 50% reduction in coronary heart disease risk in 12 months and the risk of a stroke is reduced to that of a nonsmoker 5-15 years after quitting. (US Surge...
Smoking
nicotine replacement therapy smoking cessation
null
1
arm 1: Nicotine Replacement Therapy as per monograph \& behavioural intervention
[ 0 ]
2
[ 0, 5 ]
intervention 1: nicotine transdermal patches as per product monograph intervention 2: Smoking cessation counselling and relapse prevention
intervention 1: nicotine replacement therapy intervention 2: behavioural intervention
1
Toronto | Ontario | Canada | -79.39864 | 43.70643
0
NCT00352781
[ 5 ]
642
RANDOMIZED
FACTORIAL
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more effective than counseling and the nicotine patch in helping adult smokers quit smoking. PURPOSE: This randomized phase III trial i...
OBJECTIVES: Primary * Compare the efficacy of behavioral counseling and nicotine-replacement therapy with either oral nicotine lozenge (NL) or transdermal nicotine patch (NP), in terms of promoting rates of smoking cessation (e.g., continued abstinence), in adult smokers. * Examine the degree to which nicotine replac...
Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder
bladder cancer cervical cancer esophageal cancer gastric cancer renal cell carcinoma adult primary liver cancer non-small cell lung cancer small cell lung cancer pancreatic cancer hypopharyngeal cancer laryngeal cancer lip and oral cavity cancer nasopharyngeal cancer oropharyngeal cancer paranasal sinus and nasal cavit...
null
2
arm 1: Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14. arm 2: Participants receive one oral nicotine lozenge every 1-2 hours in w...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: nicotine lozenge intervention 2: transdermal nicotine patch
intervention 1: nicotine lozenge intervention 2: nicotine patch
10
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Miami Beach | Florida | United States | -80.13005 | 25.79065 Augusta | Georgia | United States | -81.97484 | 33.47097 Mount Holly | New Jersey | United States | -74.78766 | 39.99289 East Syracuse | New York | United States | -76.07853 | 43.06...
0
NCT00365508
[ 0 ]
22
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to determine whether a particular substance involved in inflammation, called leukotrienes, is involved in causing heart disease to occur or to progress.
The focus of this study is to better understand why some adults develop heart disease and others do not. There are many known factors which play a role in causing heart disease, such as diet and lifestyle. Also, we know that inflammation, a process in the body which causes painful joints in arthritis or swelling at a s...
Coronary Heart Disease
coronary heart disease montelukast inflammation
null
2
arm 1: 1 lactose-containing capsule daily for 1 month arm 2: 1 montelukast 10 mg tablet (masked by capsule) daily for 1 month
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: 10 mg tablet (masked by capsule) daily for 1 month intervention 2: 1 lactose-containing capsule daily for 1 month
intervention 1: montelukast intervention 2: Placebo
1
Gainesville | Florida | United States | -82.32483 | 29.65163
0
NCT00379808
[ 2, 3 ]
58
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
3TRIPLE
true
0ALL
true
In congestive heart failure, cardiac output is low, blood pressure is high, and the body becomes congested with fluid. In normal people, when there is high blood pressure, the heart muscle cells secrete a hormone that excretes sodium and water in the urine, reducing blood pressure. The action of this hormone is called ...
The American Heart Association and the American College of Cardiology define stage B heart failure (HF) as asymptomatic subjects with abnormal heart structure/function. With the advancement of cardiac imaging and biomarkers, abnormal heart structure and function can be detected before the development of symptoms. Stage...
Congestive Heart Failure
heart failure diastolic dysfunction systolic dysfunction preclinical natriuretic peptide B-type natriuretic peptide cyclic guanosine monophosphate
null
2
arm 1: In the first intervention period the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous nesiritide given in the abdomen....
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: The first 10 subjects in each group will receive a dose of 5 ug/kg and the next ten subjects will receive 10 ug/kg. intervention 2: The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. intervention 3: Normal saline 0.9% 0.25 ml/kg/min for 60 minutes
intervention 1: Nesiritide intervention 2: Placebo intervention 3: Saline
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
0
NCT00387621
[ 3 ]
14
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This is a study to explore the use of a reduced intensity transplant conditioning regimen. A conditioning regimen is the treatment that is given to prepare a body for the new bone marrow that will be received from a donor. Reduced intensity conditioning uses lower doses of chemotherapy than conventional conditioning re...
One of the complications of allogeneic stem cell transplant (ASCT) is graft versus host disease (GVHD). This is when the donor cells that are infused attack the body organs. This can cause serious illness and even death. The chance of getting serious life threatening GVHD with conventional transplant conditioning regim...
Hematologic Malignancies
Allogeneic Stem Cell Transplant
null
2
arm 1: Extracorporeal photopheresis, pentostatin and total body irradiation arm 2: Pentostatin and total body irradiation
[ 1, 1 ]
5
[ 3, 0, 4, 0, 4 ]
intervention 1: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. intervention 2: pentostatin 8mg/m2 over 48 hours by continuous infusion intervention 3: 600cGy TBI in 3 200cGy TBI fractions intervention 4: pentostatin 8m...
intervention 1: extracorporeal photopheresis intervention 2: Pentostatin intervention 3: Total Body Irradiation intervention 4: Pentostatin intervention 5: Total Body Irradiation
3
New Haven | Connecticut | United States | -72.92816 | 41.30815 Boston | Massachusetts | United States | -71.05977 | 42.35843 San Antonio | Texas | United States | -98.49363 | 29.42412
0
NCT00402714