phases
list
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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
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armGroupTypes
list
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nctid
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[ 5 ]
308
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.
null
Colonoscopy
colonoscopy bowel preparation
null
2
arm 1: Active control arm 2: Investigational dose
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: multi dose formulation (tablet/solution) for oral administration prior to colonoscopy intervention 2: multi dose preparation (tablet/solution) for oral administration prior to colonoscopy
intervention 1: PEG electrolyte lavage solution + bisacodyl - reformulation intervention 2: PEG electrolyte lavage solution + bisacodyl
6
Anaheim | California | United States | -117.9145 | 33.83529 Orange | California | United States | -117.85311 | 33.78779 San Diego | California | United States | -117.16472 | 32.71571 New Smyrna Beach | Florida | United States | -80.927 | 29.02582 Laurel | Maryland | United States | -76.84831 | 39.09928 Franklin | Tenne...
0
NCT00857272
[ 4 ]
10
RANDOMIZED
SINGLE_GROUP
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this research study is to see how certain hormones cause changes in mood and thinking in some depressed patients and to determine the effectiveness of mifepristone in treating some forms of depression. This study is conducted in conjunction with an observational study "Clinical and Biological Characteri...
Eligibility Procedures: Before entering the study and prior to any other procedures, you will be asked to read and sign this consent form. To determine if you are eligible for our study, you will then have a general medical (including menstrual cycle history on female patients) and psychiatric history taken, a physical...
Affective Disorders, Psychotic Depressive Disorder
null
2
arm 1: Receive mifepristone for 8 days arm 2: Receive placebo rather than mifepristone
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: Placebo medication
intervention 1: Mifepristone (RU-486) intervention 2: Placebo
1
Stanford | California | United States | -122.16608 | 37.42411
0
NCT00867360
[ 2 ]
44
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.
null
Diabetes Mellitus, Type 2
null
2
arm 1: MK-0941 arm 2: Placebo Comparator
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): partic...
intervention 1: MK-0941 intervention 2: Comparator: Placebo
0
null
0
NCT00873821
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
2MALE
false
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to man...
Smokeless Tobacco Use
tobacco chew nrt nicotine lozenges self-help
null
2
arm 1: Self-help counseling material and 4 mg nicotine lozenges arm 2: self help counseling material and placebo nicotine lozenges
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 4 mg nicotine lozenges, ad lib, for 12 weeks. intervention 2: Placebo nicotine lozenges
intervention 1: nicotine replacement therapy intervention 2: placebo NRT
2
Rochester | Minnesota | United States | -92.4699 | 44.02163 Eugene | Oregon | United States | -123.08675 | 44.05207
0
NCT00888459
[ 4 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.
null
Allergic Conjunctivitis
null
2
arm 1: active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). arm 2: Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 0.25% Ophthalmic Solution, one drop in each eye at each of two visits. intervention 2: Vehicle without active, one drop in each eye at each of two visits.
intervention 1: alcaftadine intervention 2: Placebo
2
Fairfield | Ohio | United States | -84.5605 | 39.34589 Mason | Ohio | United States | -84.30994 | 39.36006
0
NCT00889330
[ 2, 3 ]
40
null
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS).
null
Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS)
null
2
arm 1: Participants in the Pharmacokinetic Phase received a single 10 mg oral dose of lenalidomide on Day -7. During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or e...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Lenalidomide 5-mg capsules for oral administration intervention 2: Recombinant human erythropoietin (rhu-EPO) subcutaneous injection of 40,000 units.
intervention 1: Lenalidomide intervention 2: Recombinant human erythropoietin
1
Tampa | Florida | United States | -82.45843 | 27.94752
0
NCT00910858
[ 3 ]
24
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome. This effect is thought to result from the effect of the medication on bile acids, which can cau...
Background: Irritable bowel syndrome (IBS) affects about 15% of the U.S. population, about 5% having predominant diarrhea; current treatment is suboptimal as it may not be tolerated, lead to side effects or insufficient benefit. Bile acid malabsorption (BAM) is recognized as a cause of chronic diarrhea and has been in...
Irritable Bowel Syndrome Diarrhea
bile acid malabsorption permeability diarrhea IBS stool
null
2
arm 1: Participants received colesevelam 1.875 g twice daily arm 2: Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Welchol (Colesevelam HCL) 1.875 gram twice daily for 12-14 days intervention 2: Inert capsule matching the study drug, given twice daily
intervention 1: Colesevelam intervention 2: Placebo
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
0
NCT00911612
[ 5 ]
26
RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
true
1FEMALE
false
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of t...
Acne Vulgaris
acne irritation objective sensory methods
null
1
arm 1: Once daily use in a split face model: 1. Tretinoin gel 2. Adapalene Benzoyl peroxide
[ 0 ]
2
[ 0, 0 ]
intervention 1: Tretinoin gel 0.04% used once daily in a split-face model intervention 2: Adapalene .1% and Benzoyl peroxide 2.5%
intervention 1: Tretinoin gel intervention 2: Adapalene and Benzoyl peroxide
1
Broomall | Pennsylvania | United States | -75.35658 | 39.9815
0
NCT00919191
[ 0 ]
10
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
Involuntary oscillations of the eyes (nystagmus) impairs vision so that affected patients, who have neurological disorders such as Multiple Sclerosis (MS) , cannot read or watch TV. Two medicines have been reported to suppress nystagmus and improve vision in such patients: gabapentin and memantine. The investigators se...
The study entails careful measurements of visual acuity and precise measurements of eye movements, using a contact lens device (magnetic search coil method). In this way, it is possible to make objective and reliable measurements of the effect of each drug, which are unbiased by the investigator or the patient.
Nystagmus
gabapentin memantine nystagmus Drug treatment
null
2
arm 1: Increasing dose to 300 mg four times per day (total of 1200 mg/day) arm 2: Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: increasing to 1200 mg/day intervention 2: increasing to 40 mg/day
intervention 1: gabapentin intervention 2: memantine
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00928954
[ 2 ]
62
RANDOMIZED
FACTORIAL
null
0NONE
true
0ALL
false
The purpose of this study was to examine the role skeletal muscle perfusion plays in mediating muscle protein synthesis in healthy older and younger individuals. The investigators hypothesized that normalization of muscle perfusion in older men and women via exercise or infusion of a vasodilator would enhance nutritive...
The purpose of this study was to examine muscle protein metabolism in healthy young and elderly subjects during pharmacologic vasodilation of the lower limb vasculature in combination with increased amino acids delivery. We obtained femoral arteriovenous blood samples and v. lateralis muscle biopsies during a primed co...
Aging
metabolism exercise sodium nitroprusside
null
5
arm 1: 45 minutes of treadmill walking at 40% VO2 peak arm 2: 45 minutes of treadmill walking at 40% VO2 peak arm 3: Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min arm 4: Sodium Nitroprusside given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min arm 5:...
[ 1, 1, 1, 1, 1 ]
3
[ 10, 0, 7 ]
intervention 1: 45 minuties of treadmill walking was completed at 40% VO2 peak intervention 2: Sodium Nitroprusside was given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min intervention 3: 7.5 gram Amino Acid drink
intervention 1: Aerobic Exercise intervention 2: Sodium Nitroprusside intervention 3: Amino Acid Drink
0
null
0
NCT00945256
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the safety and benefit of Thalidomide with primary sclerosing cholangitis (PSC). This is a six month study.
At entry, patients will have a complete history and physical, blood tests, ultrasound, and will complete questionnaires. Eligible patients will take Thalidomide 400 mg once a day in the evening. Patients will start a dose of 100 mg per day for two weeks, increasing by 100 mg per day every two weeks to a maximum dose of...
Primary Sclerosing Cholangitis
PSC Thalidomide
null
1
arm 1: Participants will be treated with Thalidomide, starting at a dose of 100 mg per day, increasing the dose by 100 mg every 14 days to a maximum of 400 mg per day.
[ 0 ]
1
[ 0 ]
intervention 1: Titrate to 400 mg daily for 6 months
intervention 1: Thalidomide
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
0
NCT00953615
[ 5 ]
30
RANDOMIZED
SINGLE_GROUP
1PREVENTION
1SINGLE
true
0ALL
false
This is a single-center study, randomized, Investigator/Evaluator-blinded bilateral (split-face) comparison. The objective: To assess the benefit of the concomitant use of a Moisturizing Lotion in reducing the skin irritation induced by a adapalen gel treatment in Chinese Subjects.
The interest \& relevance of the concomitant use of a non-comedogenic moisturizer in order to decrease retinoid irritation has already been demonstrated in Caucasian patients. Such interest of associating a moisturizer when Differin® gel is prescribed has not been demonstrated in Asian populations.
Healthy Skin
null
1
arm 1: None
[ 0 ]
2
[ 0, 10 ]
intervention 1: Intra-individual (split-face) comparison: Differin® 0.1% (whole face) will be applied once daily for 4 weeks. Visits will be conducted weekly for a maximum of 5 visits. intervention 2: Intra-individual (split-face) comparison: Cetaphil® (only one side of the face) will be applied once daily for 4 weeks...
intervention 1: adapalen 0.1% intervention 2: Cetaphil®
1
Singapore | N/A | Singapore | 103.85007 | 1.28967
0
NCT00971282
[ 5 ]
22
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures. We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD pa...
null
Major Depressive Disorder Soft Tissue Discomfort Syndrome Pain
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 30-60 mg daily for 8 weeks
intervention 1: Duloxetine
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT01035073
[ 4 ]
208
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
null
Growth Disorders Intrauterine Growth Retardation
Short height intra-uterine growth retardation Genotonorm continuous treatment intermittent treatment
null
3
arm 1: Continuous 0.7 IU/kg/week or 0.03 mg/kg/day arm 2: Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day arm 3: Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection intervention 2: 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection intervention 3: 1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)
intervention 1: Genotonorm intervention 2: Genotonorm intervention 3: Genotonorm
31
Angers | France | France | -0.55202 | 47.47156 Grenoble | France | France | 5.71479 | 45.17869 Paris | France | France | 2.3488 | 48.85341 Amiens | N/A | France | 2.3 | 49.9 Besançon | N/A | France | 6.01815 | 47.24878 Bordeaux | N/A | France | -0.5805 | 44.84044 Bordeaux | N/A | France | -0.5805 | 44.84044 Boulogne | ...
0
NCT01073605
[ 2 ]
24
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
2MALE
false
This study will determine if MK-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.
Up to three planned panels of either 8 healthy participants (Panels A and B) or 8 participants with mild to moderate hypertension (Panel C) will be enrolled. In Panels A and B, 8 participants will alternately receive single rising doses of MK-3614 or placebo. All doses will be administered in the fasted state, except P...
Hypertension
null
3
arm 1: Healthy participants receive single oral dose of MK-3614 0.25 mg, 1.25 mg, 0.25 mg w/ food, 0.75 mg or matching placebo. There is at least a 7-day washout between the 4 dosing periods. All doses were administered after an 8-hour fast except for Period 3. Period 3 dose was administered after the ingestion of a hi...
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: MK-3614 intervention 2: Comparator: Placebo
0
null
0
NCT01104545
[ 4 ]
288
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
This was a multicenter, open-label extension study for subjects completing either of 2 pivotal efficacy studies (NCT00401193 or NCT00386308). The study consisted of a treatment phase of 9 menstrual periods to assess the safety of tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (ma...
null
Menorrhagia
Menorrhagia Heavy Menstrual Bleeding Lysteda
null
1
arm 1: Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
[ 0 ]
1
[ 0 ]
intervention 1: Tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation for 9 menstrual periods.
intervention 1: Tranexamic acid
92
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United State...
0
NCT01280981
[ 2 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
2MALE
false
The purpose of this study is to investigate how the body processes prasugrel and how prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of prasugrel will be given. Information on side effects will also be collected.
null
Healthy Volunteers
null
3
arm 1: Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days arm 2: Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days arm 3: Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Tablets orally
intervention 1: Prasugrel
1
Seoul | N/A | South Korea | 126.9784 | 37.566
0
NCT01591317
[ 5 ]
59
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.
null
Hepatitis B, Chronic
null
1
arm 1: Eligible participants with HI3vAg (a type of Hepatitis B surface antigen) negative chronic hepatitis B will be administered peginterferon alpha-2a (PEGASYS), 40kD, 180 micrograms (mcg) subcutaneously once weekly for 48 weeks. The untreated Follow-up will be for 24 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: 180 mcg subcutaneously weekly, 48 weeks
intervention 1: Peginterferon alfa-2a [Pegasys]
4
Casablanca | N/A | Morocco | -7.61138 | 33.58831 Casablanca | N/A | Morocco | -7.61138 | 33.58831 Rabat | N/A | Morocco | -6.83255 | 34.01325 Rabat | N/A | Morocco | -6.83255 | 34.01325
0
NCT01787279
[ 0 ]
164
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes wi...
Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more e...
Smoking Cessation
Smoking cessation Tobacco abstinence hypnotherapy Nicotine replacement therapy
null
4
arm 1: Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telep...
[ 0, 0, 0, 4 ]
2
[ 5, 0 ]
intervention 1: One 90 minute session within 2 weeks of hospital discharge intervention 2: free one month supply after hospital discharge
intervention 1: hypnotherapy intervention 2: Nicotine
1
Salem | Massachusetts | United States | -70.89552 | 42.51977
0
NCT01791803
[ 2 ]
44
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
null
Type 2 Diabetes
null
4
arm 1: ITCA 650 (exenatide in DUROS) arm 2: ITCA 650 (exenatide in DUROS) arm 3: ITCA 650 (exenatide in DUROS) arm 4: ITCA 650 (exenatide in DUROS)
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: ITCA 650 (exenatide in DUROS)
3
Miami Gardens | Florida | United States | -80.2456 | 25.94204 Cincinnati | Ohio | United States | -84.51439 | 39.12711 San Antonio | Texas | United States | -98.49363 | 29.42412
0
NCT01798264
[ 0 ]
79
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
true
The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patie...
Inclusion criteria: Men and women, ≥ 60 years of age with a recent fracture of the femoral neck or trochanter, admitted to any of the four University hospitals in Stockholm, Sweden. Patients are randomized into three groups by sealed enveloped technique in blocks by 12, thus assuring that each center had an equal distr...
Hip Fracture
Hip fracture Nutritional supplement Bisphosphonates Bone mineral density Body composition
null
3
arm 1: 35 mg risedronate orally administered once weekly for 12 months and orally administered Calcium 1000 mg and 800 IU vitamin D3 daily for 12 months. Group B (bisphosphonate group) arm 2: Oral liquid nutritional supplement (600kcal and 40 gram protein/day) for 6 months after the hip fracture besides Risedronate and...
[ 1, 1, 1 ]
3
[ 0, 10, 7 ]
intervention 1: The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months. intervention 2: The bisphosphonate and nutritional supplemented group (BN) receive 35 mg risedronate once weekly for 12...
intervention 1: Risedronate intervention 2: Nutritional supplement intervention 3: Calcium and vitamin D3
1
Stockholm | N/A | Sweden | 18.06871 | 59.32938
0
NCT01950169
[ 5 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to see if patients with chronic kidney disease have endothelial cells that don't function properly, which is thought to be a marker for cardiovascular risk. Endothelial cells line the heart and blood vessels. The investigators will treat your high cholesterol with a cholesterol-lowering dru...
null
Chronic Kidney Disease High Cholesterol
Chronic kidney disease High cholesterol
null
1
arm 1: Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood ...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Atorvastatin
0
null
0
NCT02133534
[ 2 ]
22
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
2MALE
false
To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).
Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo w...
Parkinson's Disease (PD)
Parkinson's disease (PD) Opicapone BIA 9-1067
null
4
arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.) arm 2: Period 1: BIA 9-1067 50 ...
[ 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: OPC, Opicapone intervention 2: PLC, Placebo intervention 3: controlled-release levodopa 100 mg/benserazide 25 mg
intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Madopar® HBS
1
S. Mamede Do Coronado | Trofa | Portugal | N/A | N/A
0
NCT02169466
[ 2 ]
30
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
To determine the relative bioavailability of 150 mg of dabigatran etexilate as pellets on food and of 150 mg of dabigatran etexilate as powder resolved in reconstitution solution, both with 150 mg of dabigatran etexilate as capsule in healthy volunteers
null
Healthy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Dabigatran etexilate pellets intervention 2: Dabigatran etexilate powder intervention 3: Dabigatran etexilate capsule
0
null
0
NCT02171611
[ 5 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Current opinion regarding the use of steroids in the treatment of chronic subdural hematomas are mostly based on observational studies. Here we present data from a prospective randomized pilot study of twenty chronic subdural hematoma (CSDH) patients treated with dexamethasone or placebo for 30 days. Twenty patients w...
Patients Recruitment for this single-center double-blind randomized placebo-controlled study was performed between January 2007 and May 2009. Patients were enrolled based on the following inclusion criteria: 18 years and older with evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tom...
Hematoma, Subdural, Chronic
[C10.228.140.300.535.450.400.120]
null
2
arm 1: Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs). arm 2: Identical oral capsules filled with ...
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs). intervention 2: Identical oral capsules filled with lactose were admini...
intervention 1: Dexamethasone intervention 2: Placebo
0
null
0
NCT02362321
[ 3 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.
null
Hepatitis D, Chronic
null
2
arm 1: Participants will receive peginterferon alfa-2a alone, administered over 48 weeks. arm 2: Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection. intervention 2: Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin
1
Cagliari | N/A | Italy | 9.11917 | 39.23054
0
NCT02731131
[ 3 ]
14
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study is being conducted to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in adult subjects with squamous cell carcinoma of the head and neck (SCCHN). GSK1363089 is a new chemical entity that inhibits multiple receptor tyrosine kinases (RTKs) with growth-promoting and...
null
Neoplasms, Head and Neck
VEGFR2 XL880 foretinib Squamous Cell Cancer of the Head and Neck MET GSK1363089
null
1
arm 1: Participants who qualified for study entry received 240 mg of GSK1363089 (foretinib) on a 5-day on 9-day off schedule every 2 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: Multitargeted tyrosine kinase inhibitor
intervention 1: GSK1363089 (foretinib)
11
Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.85003 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 St Louis | Missouri | United States | -90.19789 | 38.62727 Lebanon | New Hampshire...
0
NCT00725764
[ 4 ]
140
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in participants undergoing laparoscopic cholecystectom...
In those surgical procedures where a neuromuscular block is desired for intubation and/or avoid unwanted muscular activity, anesthesiologists may use a more profound NMB until the end of surgery, e.g. in open abdominal procedures or during laparoscopic procedures in order to improve surgical conditions. Reversal with s...
Anesthesia, General
null
2
arm 1: 4.0 mg.kg-1 sugammadex at 1-2 PTC arm 2: 50 µg.kg-1 neostigmine (with atropine in a ratio of 5:1 for neostigmine:atropine) at reappearance of T2
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Participants will receive an intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After this dose, maintenance doses of 0.1-0.2 mg.kg-1 rocuronium may be given. intervention 2: After the last dose of rocuronium has been administered, participants will receive, according to the randomization, ...
intervention 1: Rocuronium intervention 2: Sugammadex intervention 3: Neostigmine intervention 4: Atropine
0
null
0
NCT00724932
[ 3 ]
2,080
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and...
null
Pulmonary Disease, Chronic Obstructive
null
5
arm 1: Matching Placebo arm 2: Low dose arm 3: Medium dose arm 4: High dose arm 5: Tiotropium Bromide
[ 2, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Solution intervention 2: Solution intervention 3: Solution
intervention 1: BEA 2180 BR intervention 2: Tiotropium Bromide intervention 3: Placebo
178
Jasper | Alabama | United States | -87.27751 | 33.83122 Mobile | Alabama | United States | -88.04305 | 30.69436 Berkeley | California | United States | -122.27275 | 37.87159 La Jolla | California | United States | -117.2742 | 32.84727 Lakewood | California | United States | -118.13396 | 33.85363 Riverside | California ...
0
NCT00528996
[ 2, 3 ]
1
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the safety and toxicity and feasibility of double umbilical cord blood transplantation (DUCBT) in patients with selected malignant and non-malignant, and to quantify the percentage and donor sources of mixed donor chimerism following DUCBT in patients with selected malignant an...
Allogeneic stem cell transplantation from an human leukocyte antigen (HLA) matched related family donor is the treatment of choice for a wide variety of malignant and non-malignant disorders. Unfortunately, only 25% of potential recipients have an HLA matched related family donor, leaving approximately 75% of potential...
Leukemia Lymphoma Neuroblastoma Immunodeficiencies Anemia
Cord Blood Transplant Allogeneic Stem Cell Transplant
null
6
arm 1: Patients will start their pre-conditioning regimen on Day -8. Fractionated total body irradiation (TBI) will be administered twice daily for 3 days on Days -8, -7, and -6. Patients will receive Thiotepa on Days -5 and-4, Cyclophosphamide on Days -3 and -2 and- rabbit antithymocyte globulin on Days -4, -3, -2 and...
[ 0, 0, 0, 0, 0, 0 ]
10
[ 0, 4, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Each dose of alemtuzumab is to be diluted in 5% dextrose in water (D5W) or normal saling (NS) (maximum concentration: 0.3 mg/mL) for intravenous (IV) infusion over two hours. intervention 2: None intervention 3: Melphalan 45mg/m2 (1.5 mg/kg IV for children \<1 year of age or \<10 kg) diluted in 0.9% NS ...
intervention 1: Alemtuzumab intervention 2: Total Body Irradiation intervention 3: Melphalan intervention 4: Busulfan intervention 5: Phenytoin intervention 6: Fludarabine intervention 7: Cyclophosphamide intervention 8: Horse Antithymocyte Globulin intervention 9: Rabbit Antithymocyte Globulin intervention 10: Thiotep...
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00801931
[ 4 ]
1,050
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.
This is an open-label, multiple-dose, multiple-day, single-arm safety study of repeat-doses of DIC075V in patients with acute post-operative pain following abdominal (i.e., non-laparoscopic abdominal surgeries) or orthopedic (e.g., hip or knee joint replacement) surgery. Eligible patients will receive DIC075V IV bolus ...
Pain, Postoperative
safety diclofenac pain, postoperative
null
1
arm 1: IV administration of multiple doses of DIC075V (intravenous diclofenac sodium) over multiple days
[ 0 ]
1
[ 0 ]
intervention 1: multiple doses up to 5 days
intervention 1: DIC075V (intravenous diclofenac sodium)
46
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Florence | Alabama | United States | -87.67725 | 34.79981 Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | United States | -86.29997 | 32.36681 Montgomery | Alabama | Uni...
0
NCT00726388
[ 3 ]
204
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study is to look at the preliminary efficacy and safety of 2 dose regimens of apremilast (20 mg twice a day and 40 mg once a day) versus placebo in patients with active psoriatic arthritis.
Prior to the implementation of Amendment 1/UK3 the study consisted of 3 phases - pre-randomization up to 35 days, up to 84 days placebo-controlled treatment and a 28-day observational follow up. After the implementation of Amendment 1/UK3, the study consisted of 4 phases - pre-randomization up to 35 days, up to 84 days...
Psoriatic Arthritis
psoriatic arthritis ACR PASI DAS pharmacokinetic biopsy
null
3
arm 1: Participants received 40 mg apremilast orally once a day (QD) for 12 weeks in the Treatment Phase. Participants who entered the Extension Phase continued to receive 40 mg apremilast QD for an additional 12 weeks. The dose of apremilast was titrated starting at 10 mg QD during Days 1 to 3 followed by 20 mg QD du...
[ 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Capsules for oral administration intervention 2: Capsules for oral administration
intervention 1: Apremilast intervention 2: Placebo
38
Brussels | N/A | Belgium | 4.34878 | 50.85045 Diepenbeek | N/A | Belgium | 5.41875 | 50.90769 Leuven | N/A | Belgium | 4.70093 | 50.87959 Merksem | N/A | Belgium | 4.44903 | 51.24623 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Victoria | British Columbia | Canada | -123.35155 | 48.4359 St. John's | Ne...
0
NCT00456092
[ 3 ]
60
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
false
The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis
null
Allergic Conjunctivitis
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
2
[ 0, 10 ]
intervention 1: Ophthalmic Solution intervention 2: Ophthalmic Solution
intervention 1: Lifitegrast intervention 2: Placebo
1
Andover | Massachusetts | United States | -71.137 | 42.65843
0
NCT00882687
[ 4 ]
234
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP), with a 6-month Safety Follow-up. Patients randomized to romiplostim must complete the taper or discontinuation of medi...
null
Idiopathic Thrombocytopenic Purpura Thrombocytopenia Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenic Purpura
splenectomy platelet AMG 531 thrombopoietin blood disorder bleeding disorder immune thrombocytopenic purpura idiopathic thrombocytopenic purpura immune (idiopathic) thrombocytopenic purpura TPO thrombopoietic protein
null
2
arm 1: Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10\^9/L for up to 52 weeks. arm 2: Medical standard of care treatments were selected and prescribed by the investigator according ...
[ 0, 5 ]
2
[ 0, 2 ]
intervention 1: None intervention 2: None
intervention 1: Medical Standard of Care for ITP intervention 2: Romiplostim
0
null
0
NCT00415532
[ 3 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.
Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infe...
Bronchiectasis
Bronchiectasis Respiratory Infections Amikacin Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Pseudomonas aeruginosa Amikacin liposome inhalation suspension (ALIS)
null
4
arm 1: Subjects in this arm of the cohort 1 will receive 280 mg of Arikayce™ arm 2: Subjects in this arm of the cohort 1 will receive matching placebo. arm 3: Subjects in this arm of the cohort 2 will receive 560 mg of Arikayce™ arm 4: Subjects in this arm of the cohort 2 will receive matching placebo
[ 0, 2, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Study subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 2: Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer. intervention 3: Study subjects will receive Arikace™ 560 m...
intervention 1: 280 mg Arikayce™ intervention 2: Matching Placebo for Cohort 1 intervention 3: 560 mg Arikayce™ intervention 4: Matching Placebo for Cohort 2
18
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Athens | N/A | Greece | 23.72784 | 37.98376 Mosdós | N/A | Hungary | 17.98853 | 46.35379 Bangalore | N/A | India | 77.59369 | 12.9...
0
NCT00775138
[ 4 ]
3,834
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a multicenter study to evaluate potential decrease in hospitalization events and time between events and increasing longevity in patients with symptomatic congestive heart failure and intolerant of first-line medication for heart failure. This study will evaluate if higher doses of the investigational drug give...
null
Heart Failure
null
2
arm 1: 50-mg losartan tablet administered daily with 1 tablet of 100-mg losartan placebo beginning Week 1 and continuing to end of study (up to 4 years) arm 2: Titrated losartan administration up to daily 150-mg losartan: Week 1, daily 50-mg losartan tablet coadministered with 100-mg losartan placebo; Week 2, daily 50-...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 50-mg losartan oral tablet intervention 2: 100-mg losartan oral tablet + 50-mg losartan oral tablet
intervention 1: Losartan 50 mg intervention 2: Losartan 150 mg
0
null
1
NCT00090259
[ 2 ]
18
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This study will assess the effects of sitagliptin and metformin alone and after co-administration on incretin hormone concentrations in patients with Type 2 diabetes.
null
Type 2 Diabetes Mellitus
null
4
arm 1: None arm 2: None arm 3: Co-administration of sitagliptin and metformin arm 4: Co-administration of placebo to sitagliptin and placebo to metformin
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Sitagliptin 100 mg tablet on Day 1 and Day 2 in the morning. There will be a 7-day washout between treatment periods. intervention 2: Metformin 500 mg tablet in the morning and evening on Day 1 and two 500 mg tablets of metformin (total dose 1000 mg) on Day 2 in the morning. There will be a 7-day washou...
intervention 1: sitagliptin phosphate intervention 2: metformin hydrochloride intervention 3: Comparator: placebo sitagliptin intervention 4: Comparator: placebo metformin
0
null
0
NCT00830076
[ 4 ]
682
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.
This trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the non-immunogenicity and safety of corifollitropin alfa in participants undergoing repeated COS cycles for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a multiple dose GnRH antagonist protocol. The t...
In Vitro Fertilization
Infertility Pharmacological effects of drugs Hormones, Hormone Substitutes and Hormone Antagonists Pharmacological Actions Multi-center
null
1
arm 1: Up to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and contin...
[ 0 ]
5
[ 0, 2, 2, 2, 0 ]
intervention 1: Corifollitropin alfa 150 µg administered as a single subcutaneous dose. intervention 2: FSH administerd subcutaneously at a dose not to exceed 225 IU/day. intervention 3: GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day. intervention 4: (rec)hCG administered subcutaneously at a dose ...
intervention 1: Corifollitropin alfa intervention 2: FSH intervention 3: GnRH antagonist intervention 4: (rec)hCG intervention 5: Progesterone
0
null
0
NCT00696878
[ 4 ]
356
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).
null
Epilepsy
null
2
arm 1: For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets will be administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet will be administered twice daily and increased by 1 tab...
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance pha...
intervention 1: Placebo intervention 2: Rufinamide
77
Mobile | Alabama | United States | -88.04305 | 30.69436 Northport | Alabama | United States | -87.57723 | 33.22901 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United ...
0
NCT00334958
[ 3 ]
660
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
A study to assess the safety and efficacy of MK0974 for preventing migraines in patients with episodic migraine.
null
Migraine
null
3
arm 1: Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks arm 2: Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks arm 3: Participants receive one 140 mg telcagepant placebo and one...
[ 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Telcagepant 140 mg intervention 2: Telcagepant 280 mg intervention 3: 140 mg telcagepant placebo intervention 4: 280 mg telcagepant placebo
0
null
0
NCT00797667
[ 2 ]
19
RANDOMIZED
CROSSOVER
2DIAGNOSTIC
2DOUBLE
false
0ALL
false
This study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.
null
Allergic Rhinitis
null
3
arm 1: placebo arm 2: 10 mg prednisone arm 3: 25 mg prednisone
[ 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks intervention 2: Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks. intervent...
intervention 1: Placebo intervention 2: prednisone intervention 3: prednisone
0
null
0
NCT00828061
[ 4 ]
681
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
The purpose of this research study is to investigate whether or not maribavir is safe and effective for preventing CMV disease when taken by mouth for up to 12 weeks in patients who have had a stem cell transplant.
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and effic...
Cytomegalovirus Infections
prevention prophylaxis Cytomegalovirus CMV allogeneic stem cell transplant SCT
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 100 mg twice daily for up to 12 weeks intervention 2: twice daily for up to 12 weeks
intervention 1: maribavir intervention 2: placebo
97
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Duarte | California | United States | -117.97729 | 34.13945 La Jolla | California | United States | -117.2742 | 32.84727 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 San Francis...
0
NCT00411645
[ 4 ]
66
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
null
Hypertension
Children pediatrics High Blood Pressure Hypertension Valsartan
null
1
arm 1: Extemporaneous oral suspension prepared from valsartan tablets was administered to participants once daily. The starting dose of valsartan was 1 mg/kg, escalated to 2 mg/kg or 4 mg/kg based on mean sitting systolic blood pressure (MSSBP) control after 2 weeks up to 18 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: Extemporaneous suspension of valsartan, orally.
intervention 1: Valsartan
36
Hackensack | New Jersey | United States | -74.04347 | 40.88593 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Norfolk | Virginia | United States | -76.28522 | 36.84681 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Edegem | N/A | Belgium | 4.44504 | 51.15662 Ghent | N/A | Belgium | 3.71667 | 51.05 Lak...
0
NCT00457626
[ 4 ]
72
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy, safety and tolerability of donepezil in children with persistent attention impairment that is present at least 12 months after the completion of cancer treatment.
This is a double-blind, placebo-controlled, parallel group study in pediatric subjects who have persistent attention impairment following treatment for cancer. This trial has three phases: (1) pre-randomization to establish eligibility, (2) a 12-week, double-blind, placebo-controlled, parallel-group phase with dose esc...
Attention Impairment
Attention cancer chemotherapy donepezil acetylcholinesterase inhibitor
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: During the 12-week Double-Blind Phase, subjects will receive oral donepezil hydrochloride tablets starting at a dose of 3 mg once daily. Doses will be increased incrementally at successive 3-week intervals on the basis of weight and tolerability. The final daily dose will be 3, 5, or 10 mg depending on ...
intervention 1: Donepezil hydrochloride intervention 2: Placebo
31
Stanford | California | United States | -122.16608 | 37.42411 Miami | Florida | United States | -80.19366 | 25.77427 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 St Louis | Missouri | United States | -90.19789 | 38.62727 New Brunswick | New Jersey | United States | -74.45182 | 40.48622 Brooklyn | New ...
0
NCT00688376
[ 4 ]
252
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
null
The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.
null
Breast Cancer Low Bone Mineral Density Osteopenia
Breast Cancer Bone loss associated with Aromatase Inhibitor therapy (AIT) for non-metastatic BC osteopenia Low bone density
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months intervention 2: 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months
intervention 1: Placebo intervention 2: AMG 162 / Denosumab
0
null
0
NCT00089661
[ 3 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.
null
Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
null
2
arm 1: Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity. arm 2: Subjects visited the clinic on Day 0 (administratio...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Afamelanotide intervention 2: Placebo
0
null
0
NCT04425746
[ 2 ]
26
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.
Antibodies are proteins made by the immune system. They fight things that the body sees as foreign, such as bacteria and viruses. The body can also see cancer cells as foreign. When the body sees a foreign invader, it sends out antibodies that tag the invader. Once this happens, the immune system can work to destroy wh...
Cancer of Kidney Kidney Cancer Renal Cancer Neoplasms, Kidney Renal Neoplasms Renal Cell Carcinoma (RCC) Clear Cell Renal Cell Carcinoma
Kidney Cancer Renal Cancer Neoplasms, Kidney cG250 antibody Iodine 124
null
1
arm 1: Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi) /10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: 124-Iodine-cG250 (124I-cG250)
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00199888
[ 3 ]
287
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis parti...
null
Osteoporosis Postmenopausal
null
4
arm 1: After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day fro...
[ 2, 0, 0, 2 ]
4
[ 0, 7, 7, 0 ]
intervention 1: Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks. intervention 2: Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks. intervention 3: Calcium carbonate 500 mg tablet taken orally every day for 52 weeks. intervention...
intervention 1: Odanacatib intervention 2: Vitamin D3 intervention 3: Calcium carbonate intervention 4: Placebo
0
null
0
NCT00620113
[ 4 ]
616
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This open label 52-week clinical trial is designed to assess the safety and tolerability of vilazodone and to analyze genetic markers of response to vilazodone in adult patients diagnosed with MDD. This study will enroll approximately 600 patients.
Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone for 52 weeks of open label treatment. Safety measurements will include adverse events, vital signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ) scale and electrocardiogram (ECG) findings col...
Major Depressive Disorder
null
1
arm 1: Vilazodone titrated up to 40 mg/day for 1 year.
[ 0 ]
1
[ 0 ]
intervention 1: titration to 40 milligrams (mg) every day (qd) for 1 year
intervention 1: vilazodone
38
Garden Grove | California | United States | -117.94145 | 33.77391 San Diego | California | United States | -117.16472 | 32.71571 Torrance | California | United States | -118.34063 | 33.83585 Upland | California | United States | -117.64839 | 34.09751 Denver | Colorado | United States | -104.9847 | 39.73915 Coral Spring...
1
NCT00644358
[ 3 ]
25
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.
null
Psoriasis
psoriasis
null
3
arm 1: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA. arm 2: Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1. arm 3: Patients with active stable plaq...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Ruxolitinib 1.5% cream BID for 28 days
intervention 1: Ruxolitinib
4
Fridley | Minnesota | United States | -93.26328 | 45.08608 Rochester | New York | United States | -77.61556 | 43.15478 Austin | Texas | United States | -97.74306 | 30.26715 College Station | Texas | United States | -96.33441 | 30.62798
0
NCT00617994
[ 4 ]
517
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and tenofovir disoproxil...
This study was originally planned as a 48-week, Phase 3, randomized, open-label, multicenter study comparing EFV+FTC+TDF (administered as the individual component drugs) versus CBV (lamivudine/zidovudine) + EFV to assess the efficacy and safety of both treatments in ART-Naive, HIV-1 infected participants. The regimen o...
HIV Infections
Human Immunodeficiency Virus
null
2
arm 1: Participants in this group received EFV 600 mg once daily + Combivir (\[CBV\]; the fixed dose combination pill containing lamivudine 150 mg + zidovudine 300 mg) taken twice daily from the start of the study until Week 144. At Week 144 all participants who opted to roll over into the additional 96-week study exte...
[ 1, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Capsule containing 200 mg FTC, taken once daily, for 96 weeks intervention 2: Tablet containing 300 mg TDF, taken once daily, for 96 weeks intervention 3: Tablet containing 600 mg EFV, taken once daily, for 96 weeks intervention 4: Fixed-dose combination tablet containing FTC 200 mg/TDF 300 mg, once dai...
intervention 1: Emtricitabine (FTC) intervention 2: Tenofovir Disoproxil Fumarate (TDF) intervention 3: Efavirenz (EFV) intervention 4: FTC/TDF intervention 5: FTC/TDF/EFV intervention 6: Lamivudine/zidovudine
5
Beverly Hills | California | United States | -118.40036 | 34.07362 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Orlando | Florida | United States | -81.37924 | 28.53834 Chicago | Illinois | United States | -87.65005 | 41.85003 Huntersville | North Carolina | United States | -80.84285 | ...
1
NCT00112047
[ 4 ]
463
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine that panitumumab, using the proposed regimen, will safely increase progression free survival in patients with metastatic colorectal cancer who have failed available treatment options (i.e., patients who developed progressive disease or relapsed while on or after prior fluoropyr...
null
Colorectal Cancer Metastases
Metastatic Colorectal Cancer, Colon Colorectal, Rectal Cancer, Cancer Metastatic, EGFr, Clinical Trial Panitumumab, ABX-EGF Immunex, Abgenix, Amgen
null
2
arm 1: Panitumumab will be administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants develop progressive disease or are unable to tolerate study drug. Participants will also receive best supportive care (BSC) as judged appropriate by the investigator and according to institutional ...
[ 0, 5 ]
2
[ 10, 0 ]
intervention 1: Best supportive care as site routine excluding: antineoplastic chemotherapy, investigational agents, anti-EGFr(Epidermal growth factor receptor) targeting agents other than ABX-EGF(Panitumumab), experimental or approved anti-tumor therapies (e.g. Avastin), chemotherapy, radiotherapy (with the exception ...
intervention 1: Best supportive care intervention 2: Panitumumab
0
null
1
NCT00113763
[ 4 ]
344
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To provide treatment to eligible subjects who have successfully completed one of the following phase III ziprasidone studies, A1281028, A1281044, A1281045 (NCT00136994) or A1281088 (NCT00143351).
null
Schizophrenia
Open-label extension Ziprasidone study in Schizophrenia
null
0
null
null
1
[ 0 ]
intervention 1: 20mg capsules BID, 40mg capsules BID, 60mg BID or 80mg BID until drug commercialisation in Italy.
intervention 1: Ziprasidone
87
Sora | Frosinone | Italy | 13.61356 | 41.71829 Parma | PR | Italy | 10.32618 | 44.79935 Acri, CS | N/A | Italy | 16.38635 | 39.49624 Arezzo | N/A | Italy | 11.88068 | 43.46276 Arona (No) | N/A | Italy | 8.55715 | 45.7589 Bassano del Grappa | N/A | Italy | 11.72739 | 45.76656 Bisceglie (BA) | N/A | Italy | 16.50104 | 41...
1
NCT00139737
[ 5 ]
2,252
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combina...
null
Non-Squamous Non-Small Cell Lung Cancer
null
1
arm 1: Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chem...
[ 0 ]
2
[ 0, 0 ]
intervention 1: As prescribed intervention 2: 15 mg/kg IV on Day 1 of each 3 week cycle
intervention 1: Platinum-based chemotherapy intervention 2: Bevacizumab [Avastin]
369
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Chaco-resistencia | N/A | Argentina | N/A | N/A Córdoba | N/A | Argentina | -64.18853 | -31.40648 Córdoba | N/A | Argentina | -64.18853 | -31.40648 San Miguel de Tucumán | N/A | Argentina | -65.21051 | -26.81601 St Leonards | New South Wales | Australia | 151.19836...
1
NCT00451906
[ 4 ]
1,467
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.
This study consists of a double-blind, double-dummy, parallel-group comparison of 23 mg donepezil SR with the currently marketed donepezil formulation (10 mg donepezil IR) in patients with moderate to severe Alzheimer's disease. Patients must have been taking 10 mg IR (or a bioequivalent generic) for at least 3 months ...
Alzheimer's Disease
Moderate to Severe Alzheimer's Disease
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation. intervention 2: Patients will receive study medication orally, once daily, for 24 weeks...
intervention 1: Aricept (donepezil SR 23 mg) intervention 2: Aricept (donepezil IR 10 mg)
1
Hickory | North Carolina | United States | -81.3412 | 35.73319
1
NCT00478205
[ 5 ]
289
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion. Main Secondary objectives: To compare insulin glulisine, insulin aspart and insulin lispro on: * Unexplained ...
The maximal duration of the study participation for patients was 41 weeks and one day, split in: * a 2-week screening period, * a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insu...
Diabetes Mellitus, Type 1
null
3
arm 1: sequence 1: insulin glulisine / insulin aspart / insulin lispro. arm 2: Sequence 2: insulin aspart / insulin lispro / insulin glulisine arm 3: Sequence 3: insulin lispro / insulin glulisine / insulin aspart
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump intervention 2: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump intervention 3: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
intervention 1: Insulin glulisine intervention 2: Insulin lispro intervention 3: Insulin aspart
12
Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Macquarie Park | N/A | Australia | 151.12757 | -33.78105 Vienna | N/A | Austria | 16.37208 | 48.20849 Paris | N/A | France | 2.3488 | 48.85341 Budapest | N/A | Hungary | 19.04045 | 47.49835 Netanya | N/A | Israel | 34.85992 | 32.33291 Milan | N/A | Italy |...
1
NCT00607087
[ 4 ]
2,322
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.
null
Chemotherapy-Induced Nausea and Vomiting (CINV)
null
2
arm 1: Arm 1: study medication arm 2: Arm 2: Active comparator
[ 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1. intervention 2: Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3). intervention 3: Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4. intervention 4: Oral do...
intervention 1: Comparator: fosaprepitant dimeglumine intervention 2: Comparator: Aprepitant intervention 3: Dexamethasone intervention 4: Dexamethasone intervention 5: Ondansetron
0
null
1
NCT00619359
[ 3 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.
null
Pneumonia, Bacterial
null
3
arm 1: Loading dose of IV sulopenem with switch to oral PF-03709270 arm 2: IV sulopenem with switch to oral PF-03709270 arm 3: IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Sulopenem - 600 mg infused over 1 hour, single loading dose and switch to oral PF-03709270 - 1000 mg twice a day intervention 2: Sulopenem - 600 mg infused over 1 hour twice daily for a minimum of 2 days and switch to oral PF-03709270 - 1000 mg twice a day intervention 3: IV ceftriaxone (2g) infused ove...
intervention 1: sulopenem and PF-03709270 intervention 2: Sulopenem and PF-03709270 intervention 3: Ceftriaxone and amoxicillin/clavulanate
24
Chula Vista | California | United States | -117.0842 | 32.64005 Chula Vista | California | United States | -117.0842 | 32.64005 Oceanside | California | United States | -117.37948 | 33.19587 Oceanside | California | United States | -117.37948 | 33.19587 Moline | Illinois | United States | -90.51513 | 41.5067 Rock Islan...
1
NCT00797108
[ 2, 3 ]
54
null
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
To assess the safety of dasatinib (BMS-354825) in subjects with Imatinib resistant or intolerant chronic myelogenous leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) who are resistant or intolerant to treatment and will continue study drug after completing the previous Phase ...
null
Chronic Myelogenous Leukemia Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
null
3
arm 1: CML - Chronic Phase arm 2: CML - Accelerated Phase and Blast Phase arm 3: Ph+ Acute Lymphoblastic Leukemia
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Tablet, Oral, (50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID
intervention 1: dasatinib
0
null
1
NCT01030718
[ 3 ]
2
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem cell transplantation can also cure a variety of non-cancerous, inherited or acquired disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell transplantation is a risky procedure. For some non-c...
OBJECTIVES: Primary Objective(s): 1. Evaluate the feasibility in terms of mortality, occurrence of acute graft versus host disease, and grades 3-4/4 toxicity of in vivo and in vitro Campath coupled with concomitantly administered nonmyeloablative fludarabine, cyclophosphamide and total body irradiation (TBI) followed...
Sickle Cell Anemia Severe Aplastic Anemia Paroxysmal Nocturnal Hemoglobinuria (PNH) Pure Red Cell Aplasia
sickle cell anemia severe aplastic anemia
null
2
arm 1: Campath, Chemo and/or TBI Allo SCT arm 2: Campath, Chemo and/or TBI Allo SCT
[ 0, 0 ]
1
[ 0 ]
intervention 1: Allogeneic PBSC/marrow will be collected/harvested from the donor after granulocyte colony-stimulating factor (G-CSF) priming. The allogeneic PBSCs will be infused as per current institutional practice.
intervention 1: Campath, Chemo and/or TBI Allo SCT
2
Orlando | Florida | United States | -81.37924 | 28.53834 Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00004143
[ 3 ]
29
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Donor: This clinical study will evaluate the feasibility of a purified CD34 peripheral blood progenitor cell (PBPC) transplants in patients with hematological malignancies. The primary objectives of the study are to evaluate the recipient obtaining donor derived neutrophil engraftment and the incidence of acute graft...
Donor Description: Before taking part in this study, donors will have an evaluation that is the standard for any bone marrow or blood stem cell donor. These include standard blood tests, an electrocardiogram (EKG), and a chest X-ray. Donors will also be given a general health questionnaire that is given to all blood d...
Leukemia Lymphoma
Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Myelodysplastic Syndrome Chronic Lymphocytic Leukemia Leukemia Lymphoma Non Hodgkin's Lymphoma T cell depletion CD34 selected progenitors cell GVHD
null
1
arm 1: CD34 peripheral blood progenitor cell (PBPC) transplants in 3 groups: 1) HLA-matched Sibling Transplant Patients; 2) Unrelated Donor Transplant Patients; 3) Haplo Identical Transplant Patients. Preparative regimen is 140 mg/m\^2 Melphalan on day -8, 10 mg/kg Thiotepa on day -7, 160 mg/m\^2 Fludarabine over 4 day...
[ 0 ]
5
[ 3, 0, 0, 0, 0 ]
intervention 1: Haploidentical peripheral blood progenitor cell (PBPC) transplants on Day 0. intervention 2: 140 mg/m\^2 on day -8 intervention 3: 10 mg/kg on day -7 intervention 4: 160 mg/m\^2 over 4 days on days -6, -5, -4, -3 intervention 5: 1.5 mg/kg of Rabbit ATG a day times 4 over 4 days on days -6, -5, -4, -3.
intervention 1: Megadose of CD34 Selected Progenitor Cells intervention 2: Melphalan intervention 3: Thiotepa intervention 4: Fludarabine intervention 5: Rabbit ATG
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00038857
[ 4 ]
156
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This 4-8 month study, with a 2-year follow up period, will compare sertraline (Zoloft®), venlafaxine (Effexor®), supportive-expressive psychotherapy, and placebo to determine which is more effective in treating major depression.
MDD is one of the most prevalent psychiatric disorders. Different forms of psychotherapy for depression have been found effective. This study compares a form of dynamic psychotherapy called supportive-expressive psychotherapy to medication and to placebo. Participants are evaluated on 2 occasions, 1 week apart, before...
Depression
Major Depressive Disorder
null
3
arm 1: Participants receive sertraline for the first 8 weeks. Participants will receive venlafaxine if they do not respond to sertraline by week 8 arm 2: Participants will receive supportive-expressive psychotherapy. arm 3: Participants receive placebo.
[ 0, 1, 2 ]
4
[ 5, 0, 0, 0 ]
intervention 1: The aim of supportive-expressive psychotherapy is to help patients understand the causes of relationship conflicts in the context of a supportive relationship. intervention 2: Participants will receive sertraline. intervention 3: Participants will receive a pill placebo. intervention 4: Participants wil...
intervention 1: Supportive Expressive Therapy intervention 2: Sertraline intervention 3: Pill Placebo intervention 4: Venlafaxine
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00043550
[ 4 ]
449
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet k...
OBJECTIVES: * Compare the overall survival and progression-free survival of elderly patients with newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts (RAEB) in transformation, or high-risk RAEB treated with daunorubicin and cytarabine with or without zosuquidar trihydrochloride. * Compare the ...
Leukemia Myelodysplastic Syndromes
adult acute monocytic leukemia (M5b) adult acute erythroid leukemia (M6) adult acute megakaryoblastic leukemia (M7) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) refractory ...
null
2
arm 1: Induction treatment with daunorubicin, cytarabine and zosuquidar (details provided in Intervention section), followed by consolidation with Cytarabine (1500 mg/m2 every 12 hours for 6 days), then additional consolidation with the same regimen as received during induction. arm 2: Induction treatment with daunorub...
[ 0, 1 ]
6
[ 2, 2, 0, 0, 0, 0 ]
intervention 1: 250 μg/m2/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size. intervention 2: 5 μg/kg/day by e...
intervention 1: filgrastim intervention 2: sargramostim intervention 3: cytarabine intervention 4: daunorubicin hydrochloride intervention 5: zosuquidar trihydrochloride intervention 6: Placebo
92
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Aurora | Colorado | United States | -104.83192 | 39.72943 Boulder | Colorado | United States | -105.27055 | 40.01499 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Denver | Colorado | United States | -104.9847 | 39.73915 Denver | Colorado...
0
NCT00046930
[ 3 ]
7
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron) alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas are nourished by blood delivered through blood vessels whose formation is stimulated by substances produced by the tumor itself. Stopp...
Background: There is a growing belief that angiogenesis inhibition represents a potentially promising, novel therapeutic approach to highly vascular solid tumors like malignant gliomas. Thalidomide and Peg-Intron (IFN - Interferon) are attractive drugs to use in combination to test the hypothesis of combination anti-a...
Glioma
Brain Tumors Experimental Toxicities Efficacy Progression-Free Brain Tumor Glioma
null
2
arm 1: Glioblastoma multiforme is one of the most common and aggressive types of brain tumor. arm 2: Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy an...
[ 5, 5 ]
2
[ 2, 0 ]
intervention 1: 0.3 µg/kg of IFN alfa-2b (PEG-Intron once weekly) plus daily oral thalidomide, subcutaneous injection intervention 2: Two 50mg tablets (100 mg total dose) every night before bedtime starting on day one.
intervention 1: PEG-interferon alfa-2b intervention 2: Thalidomide
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00047879
[ 4 ]
101
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not yet...
OBJECTIVES: Compare local control, failure-free survival, and overall survival of patients with locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy alone, versus cisplatin and radiotherapy with hyperthermia . OUTLINE: This is a randomized, multicenter study. Patients are stratified accor...
Cervical Cancer
stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma
null
2
arm 1: Patients received cisplatin IV and concurrently underwent hyperthermia treatment over 60-90 minutes on day 1. Patients also underwent external beam radiation therapy once daily on days 1-5. Treatment repeated weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity. After completion of...
[ 0, 1 ]
4
[ 0, 3, 4, 4 ]
intervention 1: Given IV intervention 2: Patients undergo hyperthermia treatment over 60-90 minutes intervention 3: Patients undergo brachytherapy for 2-3 days intervention 4: Patients undergo external beam radiation therapy once daily on days 1-5
intervention 1: cisplatin intervention 2: hyperthermia treatment intervention 3: brachytherapy intervention 4: external beam radiation therapy
1
Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00085631
[ 3 ]
260
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment com...
The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning th...
Tobacco Use Disorder
light smokers, smoking cessation treatment programs
null
4
arm 1: bupropion and MM counseling with placebo patch arm 2: bupropion and Mayo counseling with placebo patch. arm 3: patch and MM counseling with placebo pills arm 4: patch and Mayo counseling with placebo pills
[ 0, 0, 2, 0 ]
6
[ 0, 0, 5, 5, 0, 0 ]
intervention 1: starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks. intervention 2: 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks intervention 3: Brief manual based therapy; four 15 minute session over 10 weeks. intervention 4: Manual ...
intervention 1: nicotine transdermal system intervention 2: bupropion intervention 3: Medication Management intervention 4: Mayo Counseling intervention 5: placebo patch intervention 6: placebo bupropion
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00086411
[ 3 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PRIMARY OBJECTIVES: I. To determine the antitumor activity of GW572016 in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands using objective response rates (partial and complete responses). SECONDARY OBJECTIVES: I. To determine the duration of objective response, rate and duration of stable ...
High-grade Salivary Gland Carcinoma High-grade Salivary Gland Mucoepidermoid Carcinoma Low-grade Salivary Gland Carcinoma Low-grade Salivary Gland Mucoepidermoid Carcinoma Recurrent Adenoid Cystic Carcinoma of the Oral Cavity Recurrent Salivary Gland Cancer Salivary Gland Acinic Cell Tumor Salivary Gland Adenocarcinoma...
null
1
arm 1: Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
[ 0 ]
2
[ 0, 10 ]
intervention 1: Given orally intervention 2: Correlative studies
intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis
1
Toronto | Ontario | Canada | -79.39864 | 43.70643
0
NCT00095563
[ 0 ]
8,164
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
The VITATOPS study is a multi-center, randomized, double blind, placebo-controlled secondary stroke prevention trial to determine whether the addition of vitamin supplements (B12 500 ug, B6 25 mg, Folate 2 mg) to best medical/surgical management (including modification of risk factors) will reduce the combined incidenc...
Background: Epidemiological studies suggest that raised plasma concentrations of total homocysteine (tHcy) may be a common, causal and treatable risk factor for atherothromboembolic ischemic stroke, dementia and depression. Although tHcy can be lowered effectively with small doses of folic acid, vitamin B12 and vitamin...
Stroke Transient Ischemic Attack
VITATOPS stroke prevention multivitamins homocysteine
null
2
arm 1: Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study. arm 2: Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids.
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: multivitamin intervention 2: None
intervention 1: Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug) or placebo intervention 2: Placebo
111
New York | New York | United States | -74.00597 | 40.71427 Abington | Pennsylvania | United States | -75.11795 | 40.12067 Columbia | South Carolina | United States | -81.03481 | 34.00071 Columbia | South Carolina | United States | -81.03481 | 34.00071 Gosford | N/A | Australia | 151.34399 | -33.4244 New South Wales | N...
0
NCT00097669
[ 2, 3 ]
39
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication. Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression ...
Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants....
Multiple Sclerosis Depression
Fatty Acids, Omega-3 Fish Oils Complementary Therapies
null
2
arm 1: Fish oil concentrate arm 2: Placebo oil
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA). intervention 2: soybean oil with 1% fish oil at a daily dose of 6 grams
intervention 1: Fish oil concentrate intervention 2: Placebo
1
Portland | Oregon | United States | -122.67621 | 45.52345
0
NCT00122954
[ 3 ]
27
NON_RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
true
0ALL
false
The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.
Prescription opioid abuse is becoming an increasingly widespread and serious public health concern. The 2001 National Household Survey on Drug Abuse report revealed that the number of first-time users of prescription opioid medications for non-medical reasons reached 2 million in the year 2000, a number that has quintu...
Opioid-Related Disorders Substance-Related Disorders
Opiate Opioid Abuse Liability Abuse Potential
null
2
arm 1: Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random. arm 2: Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random.
[ 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 15 mg/70 kg oxycodone administered once per day, orally. intervention 2: 30 mg/70 kg oxycodone administered once per day, orally. intervention 3: 0 mg placebo dose administered once a day, orally.
intervention 1: oxycodone 15 mg intervention 2: oxycodone 30 mg intervention 3: Placebo 0 mg
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00158184
[ 5 ]
38
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The investigators propose that treatment of the comorbid disorders (depression, anxiety, and impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES), will result in a decreased number of NES. The purpose of this study is to provide pilot testing and data to inform the future randomize...
This is a pilot, prospective, single center, randomized, placebo-controlled, double-blind trial, that assesses the number of NES in patients treated with flexible dose sertraline (Zoloft). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Second...
Convulsion, Non-Epileptic Conversion Disorder Depression Stress Disorders, Post-Traumatic
nonepileptic seizure pseudoseizure conversion disorder psychogenic Depression Anxiety Abuse post-traumatic stress disorder sertraline serotonin randomized controlled trial
null
2
arm 1: flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES arm 2: flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: flexible dose sertraline intervention 2: flexible dose placebo
intervention 1: sertraline intervention 2: placebo
1
Providence | Rhode Island | United States | -71.41283 | 41.82399
0
NCT00159965
[ 5 ]
97
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
true
This study will evaluate changes in brain energy metabolism due to treatment with escitalopram in people with major depressive disorder.
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addi...
Depression
Brain Bioenergetic Metabolism Magnetic Resonance Spectroscopy Major Depressive Disorder Treatment Response
null
1
arm 1: Participants will receive open treatment with escitalopram.
[ 0 ]
1
[ 0 ]
intervention 1: Escitalopram 10 to 30 mg per day for 12 weeks
intervention 1: Escitalopram
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00183677
[ 5 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.
Depression is a serious medical illness that is often difficult to diagnose and treat. It occurs in people of all ages, but is often overlooked in older adults. Depression frequently co-occurs with other serious illnesses, and may be mistaken by both patients and health care givers as a normal consequence of the illnes...
Depression
Major depressive disorder Rehabilitating Elderly Apathy
null
2
arm 1: Memantine for 12 weeks arm 2: Placebo for 12 weeks
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day. intervention 2: Placebo distribution is planned to mimic the active drug.
intervention 1: Memantine intervention 2: Placebo
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
0
NCT00183729
[ 4 ]
198
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms: * Paclitaxel + Carboplatin + Etoposide * Irinotecan + Gemcitabine Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with ...
Neoplasms, Unknown Primary
Neoplasms, Unknown Primary
null
2
arm 1: Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval arm 2: Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B wa...
[ 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 50 mg alternating with 100 mg PO, days 1 and 10 in regimen A intervention 2: 1000 mg/m2 IV, days 1 and 8, in regimen B intervention 3: 1000 mg/m2 IV days 1 and 8 in regimen B intervention 4: 200 mg/m2 by 1-hour IV infusion, day 1, regimen A intervention 5: Area under the curve (AUC) 6.0 IV, day 1, regim...
intervention 1: Etoposide intervention 2: Gemcitabine intervention 3: Irinotecan intervention 4: Paclitaxel intervention 5: Carboplatin
31
Anniston | Alabama | United States | -85.83163 | 33.65983 Huntsville | Alabama | United States | -86.58594 | 34.7304 Mobile | Alabama | United States | -88.04305 | 30.69436 Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Beverly Hills | California | United States | -118.40036 | 34.07362 Lakeland | Florida | ...
0
NCT00193596
[ 3 ]
132
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will test the hypothesis that administration of granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with acute lung injury/acute respiratory distress syndrome (ALI/ARDS) will improve the clinical course and outcome by shortening the duration of mechanical ventilation for these patients.
BACKGROUND: Respiratory failure due to ALI/ARDS remains a major health problem, despite significant progress in intensive care unit care and ventilator management. ALI/ARDS is characterized by unacceptably high mortality despite enormous expenditure of health care resources. Survivors face long-term consequences that ...
Respiratory Distress Syndrome, Adult
null
2
arm 1: Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2). arm 2: Participants will be randomized to receive placebo.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Placebo will be administered by slow intravenous infusion once daily for 14 days. intervention 2: Recombinant human GM-CSF (250 mcg/M2) will be administered by slow intravenous infusion once daily for 14 days.
intervention 1: Placebo intervention 2: GM-CSF
3
Denver | Colorado | United States | -104.9847 | 39.73915 Atlanta | Georgia | United States | -84.38798 | 33.749 Ann Arbor | Michigan | United States | -83.74088 | 42.27756
0
NCT00201409
[ 5 ]
46
NON_RANDOMIZED
PARALLEL
1PREVENTION
0NONE
true
1FEMALE
null
Oral contraceptives (OCs) are the most widely used method of reversible birth control. However, the long-term cardiovascular safety of the widely used low-dose OCs (ethinyl-estradiol \< 50 mcg) is still debated. Although cardiovascular events are rare in young women whether they use OCs or not, the risks of myocardial ...
null
Metabolic Syndrome X Insulin Resistance Obesity Cardiovascular Diseases
Inflammatory markers, oral contraceptions, obesity, metabolic syndrome X
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 1 ]
1
[ 0 ]
intervention 1: Ortho Tri Cyclen, one tablet daily, for 6 cycles
intervention 1: Ortho Tri Cyclen
1
Richmond | Virginia | United States | -77.46026 | 37.55376
0
NCT00205504
[ 5 ]
19
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.
Most liver transplant recipients receive an immunosuppressive drug regimen that contains either cyclosporine or tacrolimus. Although these drugs have revolutionized transplantation, in many patients their long-term use is a major cause of serious side effects, including kidney failure, hypertension, diabetes mellitus, ...
Liver Disease
Liver transplantation Calcineurin inhibitor withdraw mycophenolate mofetil Immunosuppression side effects Graft rejection
null
2
arm 1: mycophenolate mofetil monotherapy arm 2: mycophenolate mofetil and half their baseline dose of calcineurin inhibitor
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: mycophenolate mofetil and half their baseline dose of calcineurin inhibitor intervention 2: mycophenolate mofetil monotherapy
intervention 1: mycophenolate mofetil intervention 2: mycophenolate mofetil
3
Lexington | Kentucky | United States | -84.47772 | 37.98869 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 San Antonio | Texas | United States | -98.49363 | 29.42412
0
NCT00206076
[ 5 ]
17
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to relaxation and stress management training (RSMT), an acti...
In total, 20 BDD patients aged 16 through 65 will participate. To be eligible they must meet DSM-IV criteria for BDD, have a score of 20 or greater on the BDD modification of the Yale Brown Obsessive-Compulsive Scale (BDD-YBOCS) and be on a stable, therapeutic does of an SRI (at least 12 weeks on the SRI with 8 weeks a...
Body Dysmorphic Disorder
Body Dysmorphic Disorder SRIs Cognitive Behavioral Therapy
null
1
arm 1: Participants with body dysmorphic disorder
[ 0 ]
2
[ 5, 0 ]
intervention 1: standard psychiatric evaluation intervention 2: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.
intervention 1: Cognitive Behavioral Therapy intervention 2: Venlafaxine
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00211809
[ 3 ]
264
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
1FEMALE
true
The purpose of this study is to evaluate the efficacy of the glycine antagonist, GW468816, compared with placebo on duration of abstinence and rates of relapse in recently quit female smokers in a randomized, double-blind, five-week clinical trial. According to the investigators, the new medication, GW468816, is thoug...
Smoking is the leading cause of preventable mortality in developed countries. Pharmacotherapy, including bupropion and nicotine replacement therapy (NRT), is universally recommended for smoking cessation treatment; however, even with treatment, the majority of smokers either fail to quit in the short term or relapse in...
Nicotine Dependence
Drugs, Investigational Therapies for Relapse to Nicotine Relapse Prevention Nicotine Cessation Therapies Smoking Cessation Nicotine Dependence
null
2
arm 1: Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial arm 2: Placebo, 200 mg/day, for a 5-week trial
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Pharmacotherapies for Relapse Prevention intervention 2: None
intervention 1: GW468816 intervention 2: Placebo Comparator: Placebo
2
Belmont | Massachusetts | United States | -71.17867 | 42.39593 Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00218465
[ 4 ]
247
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.
This is a Phase III, open label, nonblinded study. A total of 240 eligible patients will be randomized on a 1:1 basis to either treatment Arm. In this trial, we will compare the efficacy, safety, and tolerability of this novel combination of biweekly infusional 5-FU/leucovorin plus cetuximab and bevacizumab (FOLF-CB) ...
Metastatic Colorectal Cancer
null
2
arm 1: (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU. Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU Dosing on Days 1 and 15 of each 28-day cycle arm 2: (FOLF-CB): Cetuximab ad...
[ 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 5 mg/kg over 30 minutes on Days 1 and 15 intervention 2: 85 mg/m2 on Days 1 and 15 intervention 3: 400 mg/m2 on Days 1 and 15 intervention 4: 400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour pe...
intervention 1: Bevacizumab intervention 2: Oxaliplatin intervention 3: Leucovorin intervention 4: Fluorouracil intervention 5: Cetuximab
82
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Sedona | Arizona | United States | -111.76099 | 34.86974 Tucson | Arizona | United States | -110.92648 | 32.22174 Fresno | California | United States | -119.77237 | 36.74773 Monterey | California | Unit...
0
NCT00252564
[ 4 ]
1,174
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline
null
Parkinson's Disease
Parkinson's Rasagiline Mesylate
null
3
arm 1: 1mg early start active treatment arm (72 weeks active)followed by 1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) arm 2: 2mg early start active treatment arm (72 weeks active)followed by 2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 ...
[ 0, 0, 2 ]
3
[ 0, 0, 10 ]
intervention 1: tablet, 1mg once daily intervention 2: tablet, 2mg once daily intervention 3: Placebo
intervention 1: Rasagiline Mesylate intervention 2: Rasagiline Mesylate intervention 3: Placebo
0
null
0
NCT00256204
[ 5 ]
755
RANDOMIZED
FACTORIAL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine wh...
The ultimate goal of RA is to eliminate symptoms, restoring the patient to normal physical, social, emotional, and vocational function, and preserving the structure and integrity of joints. While disease modifying anti-rheumatic drugs (DMARDs) have long been the cornerstone of RA therapy, the limitations of DMARDs have...
Rheumatoid Arthritis
RA painful joints swollen joints
null
4
arm 1: methotrexate (MTX) + etanercept arm 2: methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ) arm 3: methotrexate (MTX) or MTX + Etanercept arm 4: methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
[ 1, 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: varies intervention 2: varies intervention 3: varies intervention 4: varies
intervention 1: methotrexate intervention 2: sulfasalazine intervention 3: hydroxychloroquine intervention 4: etanercept
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
0
NCT00259610
[ 4 ]
221
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.
On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.
Schizophrenia
Adolescent Subjects
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.
intervention 1: Ziprasidone oral capsules
68
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 San Diego | California | United States | -117.16472 | 32.71571 Denver | Colorado | United States | -104.9847 | 39.73915 Washington D.C. | Di...
0
NCT00265382
[ 5 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications togethe...
Despite a lack of evidence to support their fears, a majority of parents, pediatricians, and pediatric nurses believe that fever can be dangerous to a child. This "fever phobia" has caused a majority of caregivers to aggressively treat fever with antipyretics such as ibuprofen and acetaminophen, often in combination. A...
Fever
fever treatment children
null
3
arm 1: At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) arm 2: At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) and an appropriate dose of Acetaminophen (15 mg/kg) arm 3: At time 0 child is given an appropriate dose of Ibuprofen (10mg/kg) and at time 3 hours is given an appropriate...
[ 1, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Given for fever control 15mg/kg intervention 2: Given for fever control 10 mg/kg
intervention 1: Acetaminophen intervention 2: Ibuprofen
1
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
0
NCT00267293
[ 5 ]
37
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients who have had a heart attack.
Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack. Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin p...
Cardiovascular Diseases Atherosclerosis Myocardial Infarction
Cardiovascular diseases Aspirin Atherosclerosis Myocardial Infarction
null
5
arm 1: 81 mg Aspirin arm 2: 162 mg Aspirin arm 3: 325 mg Aspirin arm 4: 650 mg Aspirin arm 5: 1300 mg Aspirin
[ 1, 1, 1, 1, 1 ]
1
[ 0 ]
intervention 1: Dosage
intervention 1: Aspirin
2
Atlantis | Florida | United States | -80.10088 | 26.5909 Tamarac | Florida | United States | -80.24977 | 26.21286
0
NCT00272337
[ 3 ]
62
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).
null
Kidney Neoplasms Carcinoma, Renal Cell
null
1
arm 1: AG-013736 single agent in continuous dosing until disease progression or unacceptable toxicity
[ 0 ]
1
[ 0 ]
intervention 1: AG-013736 5 mg twice daily \[bid\] continuous dosing in 28 day cycles.
intervention 1: AG-013736 (axitinib)
5
Chicago | Illinois | United States | -87.65005 | 41.85003 The Bronx | New York | United States | -73.86641 | 40.84985 Cleveland | Ohio | United States | -81.69541 | 41.4995 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Madison | Wisconsin | United States | -89.40123 | 43.07305
0
NCT00282048
[ 3 ]
237
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study is to evaluate the effects of Crestor (rosuvastatin) and (Lipitor) atorvastatin on urinary protein excretion over 1 year in non-diabetes with moderate proteinuria and hypercholesterolaemia.
null
Hyperlipidemia
Hyperlipidemia Proteinuria Diabetes Mellitus
null
0
null
null
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Rosuvastatin intervention 2: Atorvastatin
107
Avondale | Arizona | United States | -112.3496 | 33.4356 Phoenix | Arizona | United States | -112.07404 | 33.44838 Pasadena | California | United States | -118.14452 | 34.14778 Riverside | California | United States | -117.39616 | 33.95335 Clearwater | Florida | United States | -82.8001 | 27.96585 Hollywood | Florida |...
0
NCT00296400
[ 3 ]
75
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate whether treatment with rituximab plus sargramostim will be more effective than rituximab alone.
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. As of 29 August 2009, Genzyme assumed responsibility for the close out of the study. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc. The study was terminated early due t...
Lymphoma, Follicular
Sargramostim Leukine NHL
null
2
arm 1: None arm 2: None
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab intervention 2: Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
intervention 1: Sargramostim (Leukine) intervention 2: Rituximab
22
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Los Angeles | California | United States | -118.24368 | 34.05223 Montebello | California | United States | -118.10535 | 34.00946 Pleasant Hill | California | United States | -122.0608 | 37.94798 Gaines...
0
NCT00308087
[ 3, 4 ]
13
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in ...
Summary: A phase I randomized, double-blind, placebo controlled trial to investigate the efficacy of chloroquine to decrease T-cell activation and decrease viral load in early HIV. Scientific Rationale: Chloroquine has in vivo direct anti-HIV effects and an anti-inflammatory effect. These properties may be beneficia...
HIV Infections
HIV chloroquine disease progression inflammation treatment naive
null
2
arm 1: Chloroquine 205mg or 500mg orally once daily (Results pooled) arm 2: Placebo once daily for 8 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 250mg or 500mg PO (by mouth) QDay intervention 2: Placebo once daily for 8 weeks
intervention 1: chloroquine phosphate intervention 2: Placebo
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
0
NCT00308620
[ 3 ]
115
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This was an open-label, multicenter, single-arm, Phase II trial of bevacizumab combined with first- or second-line therapy in patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with previously treated central nervous system (CNS) metastases. A total of 115 patients enrolled in the study.
null
Non-Small Cell Lung Cancer Brain Neoplasms
Brain Cancer Brain Metastases Avastin NSCLC Lung Cancer PASSPORT
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be \< 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity. intervention 2: Carboplatin, cisplatin, paclitaxel, docetaxel, gemcita...
intervention 1: bevacizumab intervention 2: First-Line Chemotherapy Agents intervention 3: Second-Line Chemotherapy Agents
0
null
0
NCT00312728
[ 4 ]
7,287
RANDOMIZED
FACTORIAL
1PREVENTION
1SINGLE
false
0ALL
true
The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic control for type 2 diabetes (in ACCORD participants) on factors related to bone health, including, fractures, falls, and bone mineral density.
Recent studies have established that type 2 diabetes is a risk factor for fractures, particularly of the hip, shoulder and foot. Additionally, type 2 diabetes is associated with a 50-60% increase in the risk of falling. The higher risk of fracture associated with type 2 diabetes is an important health burden for these ...
Atherosclerosis Cardiovascular Diseases Hypercholesterolemia Hypertension Diabetes Mellitus Coronary Disease
Diabetes Mellitus Fracture Falls Height Loss
null
2
arm 1: intensive glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level below 6.0%) arm 2: standard glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of 7 to 7.9%)
[ 1, 1 ]
1
[ 0 ]
intervention 1: type 2 diabetes treatments, per standard of care
intervention 1: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents
5
Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Cleveland | Ohio | United States | -81.69541 | 41.4995 Memphis | Tennessee | United States | -90.04898 | 35.14953 Hamilton | Ontario | Canada | -79.84963 | 43.25011
0
NCT00324350
[ 4 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Parkinson's disease (PD) is the second most common neurodegenerative disease in the US, affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD complain of sleep disturbances, typically sleep fragmentation. Despite the high prevalence of sleep problems and their impact on the life of t...
Introduction and Rationale Parkinson's disease (PD) is the second most common neurodegenerative disease in the US, affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD complain of sleep disturbances, typically sleep fragmentation. This difficulty with sleep maintenance is accompanie...
Parkinson's Disease Insomnia
Parkinson's insomnia drug eszopiclone placebo
null
2
arm 1: eszopiclone. Those under 65yo received 3mg of eszoplicone ( or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone ( or randomized to matching placebo)taken each night at bedtime arm 2: Those randomly assigned to matching placebo, took their dose each night at bedtime
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: eszopiclone intervention 2: matching placebo administered at night
intervention 1: eszopiclone intervention 2: placebo
4
Suwanee | Georgia | United States | -84.0713 | 34.05149 Edison | New Jersey | United States | -74.4121 | 40.51872 Piscataway | New Jersey | United States | -74.39904 | 40.49927 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
0
NCT00324896
[ 3 ]
75
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is an investigator initiated dose finding study designed to determine the optimal dose of naloxone to prevent or minimize the most common side effects induced by opioids, namely itching, nausea, and vomiting. Male and female inpatients of the Children's Center of the Johns Hopkins Hospital, who are greater than 6 ...
In patients of all ages, opioids are the cornerstone of management of moderate to severe pain. Regardless of method of administration, all opioids produce unwanted side effects, including pruritus, nausea and vomiting, constipation, urinary retention, cognitive impairment, tolerance, dependence, and (rarely) respirator...
Pain Nausea Pruritus
morphine naloxone pediatrics adverse effects pain
null
1
arm 1: continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour
[ 0 ]
1
[ 0 ]
intervention 1: continuous infusion of naloxone administered in escalating dosing from 0.05 mcg/kg/hr to 1.65 mcg/kg/hour
intervention 1: naloxone
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
NCT00330343
[ 3 ]
143
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.
null
Bladder, Neurogenic
tamsulosin pediatric neurogenic bladder
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: oral
intervention 1: tamsulosin hydrochloride
72
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Jacksonville | Florida | United States | -81.65565 | 30.33218 Tampa | Florida | United States | -82.45843 | 27.94752 Springfield | Illinois | United States | -89.64371 | 39.80172 Indianapolis | I...
0
NCT00340704
[ 5 ]
145
RANDOMIZED
PARALLEL
2DIAGNOSTIC
3TRIPLE
false
0ALL
null
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.
null
Diagnostic Imaging
Multislice computed tomography (MSCT)indications
null
2
arm 1: The patient receive one injection of Xenetix 300 (300 mg of iodine/ml) arm 2: The patient receive one injection of Visipaque 270 (270 mg of iodine/ml)
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 300 mg of iodine/ml intervention 2: 270 mg of iodine/ml
intervention 1: Xenetix intervention 2: Visipaque
1
Rouen | N/A | France | 1.09932 | 49.44313
0
NCT00347022
[ 4 ]
111
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will 1) determine the proportion of patients with autoimmune diseases who are experiencing any GI complaints under MMF-based immunosuppressive treatment and 2) assess if a...
null
Autoimmune Disease
Autoimmune disease, mycophenolate, GI problems
null
1
arm 1: Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.
intervention 1: Enteric-coated Mycophenolate Sodium
1
Various Cities | N/A | Germany | N/A | N/A
0
NCT00351377
[ 3 ]
12
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to evaluate the ability of Phenoptin to control blood phenylalanine levels in subjects who have hyperphenylalaninemia due to a primary BH4 deficiency and to evaluate the safety of Phenoptin in this population. Some subjects were receiving non-registered formulations of BH4 at enrollment and...
Within 4 weeks of completing screening assessments to determine eligibility, subjects will be enrolled in the study. The study will be conducted in two parts. Part 1: After screening, all subjects will be followed for two weeks without modification of their baseline medical or dietary care. Part 2: Beginning at Week ...
Tetrahydrobiopterin Deficiencies Hyperphenylalaninemia, Non-Phenylketonuric
null
1
arm 1: 5mg/kg/day orally, dose may be adjusted to between 5-20 mg/kg/day by investigator at week 6 to control blood Phe levels Outcomes were also evaluated by the subject's type of BH4 deficiency either defects in the genes encoding the enzymes involved in biosynthesis or defects in the genes encoding the enzymes invo...
[ 0 ]
1
[ 0 ]
intervention 1: 5mg/kg/day orally, dose may be adjusted to between 5-20 mg/kg/day by investigator at week 6 to control blood Phe levels
intervention 1: Phenoptin
10
Los Angeles | California | United States | -118.24368 | 34.05223 Chicago | Illinois | United States | -87.65005 | 41.85003 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 New York | New York | United States | -74.00597 | 40.71427 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Portland...
0
NCT00355264
[ 3 ]
29
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis (IPF) patients function better. This study will test whether sildenafil improves the ability to exercise in patients with pulmonary fibrosis of unknown cause.
Idiopathic pulmonary fibrosis (IPF) is recognized as a predominantly noninflammatory paradigm of lung fibrosis, characterized by heterogeneous myofibroblast proliferation (usual interstitial pneumonia \[UIP\]) and a poor clinical prognosis. To date no therapies have been demonstrated in well-designed, randomized, contr...
Alveolitis, Fibrosing Fibrosis, Pulmonary Hypertension, Pulmonary
alveolitis, fibrosing exercise, aerobic fibrosis, pulmonary hypertension, pulmonary
null
2
arm 1: Sildenafil 20 mg tid orally arm 2: Identical Placebo 20 mg tid orally
[ 0, 2 ]
1
[ 0 ]
intervention 1: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
intervention 1: sildenafil
1
Miami | Florida | United States | -80.19366 | 25.77427
0
NCT00359736
[ 4 ]
330
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]).
null
Autistic Disorder Behavioral Symptoms
Serious behavioral problems in children and adolescents with AD behavioral problems
null
3
arm 1: De novo participants (those who did not participate in protocol (CN138-178 \[NCT00332241\] or CN138-179 \[NCT00337571\]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, re...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
intervention 1: Aripiprazole
55
Birmingham | Alabama | United States | -86.80249 | 33.52066 Dothan | Alabama | United States | -85.39049 | 31.22323 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tuscon | Arizona | United States | N/A | N/A Costa Mesa | California | United States | -117.91867 | 33.64113 Rolling Hills Estate | California | U...
0
NCT00365859
[ 5 ]
12
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
The goal of this study is to confirm that levetiracetam has a better tic-suppressing profile than that of the widely used tic-suppressing medication, clonidine. More specifically, the investigators hypothesize that in a 15 week placebo run-in, double-blind, medication cross-over trial; levetiracetam will be more effect...
This is a randomized, double-blind, 15 week (two treatment phase), 1 week run-in, cross-over study, in which the same patient receives 6 weeks of treatment with levetiracetam and a 6 week treatment course with clonidine, separated by a two week medication wash-out. The investigators plan to enroll twenty patients betwe...
Tic Disorders Tourette Syndrome
Tics Tourette syndrome levetiracetam clonidine
null
2
arm 1: Levetiracetam (Keppra) is used in one phase of this cross-over study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proc...
intervention 1: Levetiracetam intervention 2: Clonidine
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
0
NCT00370838