phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
4
] | 269 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp. | null | Actinic Keratosis | Peplin Actinic keratosis PEP005 | null | 2 | arm 1: PEP005 gel, 0.015% applied once daily for three consecutive days arm 2: Vehicle gel applied once daily for three consecutive days | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 0.015%, three day treatment intervention 2: Vehicle gel, three day treatment | intervention 1: PEP005 Gel intervention 2: Vehicle gel | 21 | Los Angeles | California | United States | -118.24368 | 34.05223
Oceanside | California | United States | -117.37948 | 33.19587
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Miami | Florida | United States | -80.19366 | 25.77427
Alphare... | 0 | NCT00916006 |
[
4
] | 506 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) 60 mg\~120 mg in patients with mild to moderate essential hypertension. | Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg \~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. ... | Hypertension | Hypertension Losartan | null | 2 | arm 1: Losartan group arm 2: Fimasartan 60mg, 120mg | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Fimasartan 60 \~ 120mg/po take one tablets once a day intervention 2: Losartan 50 mg \~ 100 mg/po, take one tablets once a day | intervention 1: Fimasartan intervention 2: Losartan (Control) | 0 | null | 0 | NCT00922480 |
[
0
] | 47 | RANDOMIZED | CROSSOVER | null | 2DOUBLE | false | 0ALL | false | The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assign... | null | Dry Eye Syndrome | null | 3 | arm 1: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear arm 2: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear arm 3: Glycerin and Polysorbate 80 based artificial tear | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 1 to 2 drops into each eye three times per day intervention 2: 1 to 2 drops into each eye three times per day intervention 3: 1 to 2 drops into each eye three times per day | intervention 1: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear intervention 2: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear intervention 3: Glycerin and Polysorbate 80 based artificial tear | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00932477 | |
[
0
] | 115 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 1FEMALE | false | The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals. | Pain caused by dysmenorrhea can range from mild to severe. At least 50% of all menstruating women experience appreciable pain at some time during their menstruation. An estimated 600 million work hours are lost annually to this affliction with an average loss of time of two or more workdays per year per female employee... | Dysmenorrhea | Dysmenorrhea | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
1,
0
] | intervention 1: The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation, used during menstruation to provide pain relief for women with dysmenorrhea. intervention 2: 400 mg daily | intervention 1: Vipon intervention 2: Ibuprofen | 2 | Kansas City | Missouri | United States | -94.57857 | 39.09973
Kansas City | Missouri | United States | -94.57857 | 39.09973 | 0 | NCT00951561 |
[
5
] | 78 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 4QUADRUPLE | true | 0ALL | false | The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin). | null | Healthy | Opioid Recreational Oxymorphone Oxycodone Extended Release Healthy NonDependent Recreational Opioid Users | null | 5 | arm 1: 15mg arm 2: 30mg arm 3: None arm 4: 30mg arm 5: 60mg | [
0,
1,
2,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 15mg or 30mg intervention 2: 30mg or 60mg intervention 3: The placebo was a sugar pill. intervention 4: 8 mg | intervention 1: Oxymorphone ER intervention 2: Oxycodone CR intervention 3: Placebo intervention 4: Hydromorphone | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00955110 |
[
0
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated with eczema. Over time, the complications from this disease process lead to loss of vision due to continual scarring of the corneal surface. The pathophysiology of AKC has not been fully elucidated, and the triggers are still un... | Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated with eczema. Over time, the complications from this disease process lead to loss of vision due to continual scarring of the corneal surface. The pathophysiology of AKC has not been fully elucidated, and the triggers are still un... | Atopic Keratoconjunctivitis | Atopic Keratoconjunctivitis Restasis Cyclosporine | null | 1 | arm 1: cyclosporine 0.05% ophthalmic eye drops will be used starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then will be adjusted by clinician as needed for appropriate disease control | [
0
] | 1 | [
0
] | intervention 1: Cyclosporine 0.05% ophthalmic solution, 1 drop 6 times in both eyes daily for first month, then 1 drop 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator. | intervention 1: Cyclosporin 0.05% ophthalmic | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00987467 |
[
2
] | 12 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to investigate whether ketoconazole, taken orally, influences the level of eribulin in the blood when the two drugs are given at the same time. The study will enroll patients with solid tumors whose cancer became worse even after standard treatment, or for whom there is no standard treatmen... | null | Cancer | Cancer solid tumors | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Group 1 Cycle 1 (28 days): Eribulin IV 1.4 mg/m\^2 alone on Day 1, then eribulin IV 0.7 mg/m\^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16. Subsequently, subjects were able to receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days. intervention 2: Group 2 Cy... | intervention 1: Eribulin alone intervention 2: Eribulin plus Ketoconazole | 1 | Amsterdam | North Holland | Netherlands | 4.88969 | 52.37403 | 0 | NCT01000376 |
[
5
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain no... | This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide 2.5%) and the other side of the face will rem... | Acne Vulgaris | Healthy volunteers | null | 2 | arm 1: Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel. arm 2: Once Daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel. intervention 2: Once daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel | intervention 1: Clindamycin and BPO 5% gel intervention 2: Clindamycin phosphate and benzoyl peroxide 2.5% gel. | 1 | Broomall | Pennsylvania | United States | -75.35658 | 39.9815 | 0 | NCT01015638 |
[
3
] | 150 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | false | The goal of this clinical research study is to compare the effectiveness of 3 drug schedules in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS). | Chemotherapy-related nausea and vomiting is a frequent problem among patients with leukemia that can lead to further medical problems, such as malnutrition, dehydration, electrolyte imbalance, and a lower quality of life. Cytarabine, one of the drugs that is used to treat AML and high-risk MDS, is known to cause nausea... | Acute Myelogenous Leukemia Chemotherapy-induced Nausea and Vomiting | Nausea Vomiting CINV Leukemia High-risk Myelodysplastic syndrome AML Hematologic malignancies Hematologic Disorder Continuous multi-day chemotherapy High-dose cytarabine Palonosetron Aloxi Ondansetron Zofran | null | 3 | arm 1: Standard of care, Ondansetron 8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends. arm 2: Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy treatment. arm 3: Palonosetron once a day 0.25 mg I... | [
1,
0,
0
] | 2 | [
0,
0
] | intervention 1: 8 mg IV as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends. intervention 2: Palonosetron Group 1: 0.25 mg IV bolus over 30 seconds daily for 5 days, 30 minutes before cytarabine chemotherapy.
Palonosetron Group 2: 0.25 mg IV bolus over 30 seconds on... | intervention 1: Ondansetron intervention 2: Palonosetron | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT01031498 |
[
3,
4
] | 32 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | The goal of this proposal is to explore the potential effectiveness of varenicline to treat tobacco dependence among recovering alcoholic smokers who, as a group, are at high risk for tobacco-caused morbidity and mortality. In this open-label phase II clinical trial, we are proposing to enroll 32 recovering alcoholic s... | This is an open-label, phase II clinical trial. All subjects will be screened for study eligibility after providing informed consent. During the clinic screen visit the subjects are informed of the study, the study informed consent is signed by the subject and staff member, a series of screening tests are conducted and... | Tobacco Abstinence | Tobacco Dependence Smoking Tobacco Cessation | null | 1 | arm 1: Everyone on study will receive Varenicline daily for 12 weeks | [
5
] | 1 | [
0
] | intervention 1: During the first week varenicline will be started at a dose of 0.5 mg once daily for days 1-3; then 0.5 mg twice daily for days 4-7. Target quit date is set at day 8. Varenicline is then continued for weeks 2-12 at a dose of 1 mg twice daily. | intervention 1: Varenicline | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT01092702 |
[
5
] | 34 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To document the short term \& long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause \> 50% obstruction of the posterior choanae). | null | Adenoids | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months | intervention 1: mometasone furoate nasal spray | 0 | null | 0 | NCT01098071 | |
[
0
] | 31 | RANDOMIZED | CROSSOVER | 9OTHER | 2DOUBLE | false | 0ALL | null | Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials. | Methodology to assess reproducibility and sensitivity of quantitative sensory testing | Neuropathic Pain | Methodology Quantitative Sensory Testing Neuropathies Pain Pregabalin | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients intervention 2: BID dosing for 28 days | intervention 1: Pregabalin intervention 2: Placebo | 5 | Vienna | N/A | Austria | 16.37208 | 48.20849
Brussels | N/A | Belgium | 4.34878 | 50.85045
Boulogne-Billancourt | N/A | France | 2.24128 | 48.83545
Liverpool | N/A | United Kingdom | -2.97794 | 53.41058
London | N/A | United Kingdom | -0.12574 | 51.50853 | 0 | NCT01117766 |
[
4
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional eff... | At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional eff... | Myelodysplastic Syndromes | Myelodysplastic Syndromes MDS | null | 1 | arm 1: Azacitidine (study drug) plus best supportive care. | [
0
] | 1 | [
0
] | intervention 1: Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m\^2/day. | intervention 1: Azacitidine | 22 | East Melbourne | Victoria | Australia | 144.9879 | -37.81667
Herston | N/A | Australia | 153.01852 | -27.44453
Perth | N/A | Australia | 115.8614 | -31.95224
Woolloongabba | N/A | Australia | 153.03655 | -27.48855
Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Aulnay-sous-Bois | N/A | France | 2.49402 | 48.93814
Berlin | N/A... | 0 | NCT01186939 |
[
4
] | 678 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra. | RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site and mode of action, the combination would be expected to be more effective than either active alone, given that pain is multi-factor... | Post-operative Pain | Dental pain Ibuprofen Acetaminophen Nurofen Plus® Panadeine® Extra Paracetamol | null | 5 | arm 1: One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet arm 2: Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg arm 3: Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) arm 4: Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) arm 5: Two placebo ... | [
0,
0,
1,
1,
2
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water intervention 2: Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water intervention 3: Two tablets ibuprofen 200mg plus codeine 12.8m... | intervention 1: Ibuprofen/acetaminophen intervention 2: Ibuprofen/acetaminophen (higher dose) intervention 3: Nurofen Plus® intervention 4: Panadeine® Extra intervention 5: Placebo | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 0 | NCT01229449 |
[
5
] | 504 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia. | Epoetin alfa is an agent similar to a hormone produced in the kidney (ie, erythropoietin) that functions to increase the amount of red blood cells made in the bone marrow. This is a randomized (study drug assigned by chance), open-label (patients and their doctors will know the identity of study drug administered), saf... | Anemia Neoplasms | Epoetin alfa (EPREX, ERYPO) | null | 2 | arm 1: Epoetin alfa 450 IU/kg once a week (QW) 450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks arm 2: Epoetin alfa 150 IU/kg 3 times a week (TIW) 150 IU/kg 3 times a week (TIW) by subcutaneous injection prefer... | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 450 IU/kg once a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks. intervention 2: 150 IU/kg 3 times a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy fo... | intervention 1: Epoetin alfa 450 IU/kg once a week intervention 2: Epoetin alfa 150 IU/kg 3 times a week intervention 3: Epoetin alfa 450 IU/kg once a week (QW) intervention 4: Epoetin alfa 150 IU/kg 3 times a week (TIW) | 0 | null | 0 | NCT01394991 |
[
2
] | 28 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 2MALE | false | The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.
The purpose of this study is to establish bioequivalence of 2 imme... | null | Therapeutic Equivalency | Bioequivalence | null | 2 | arm 1: Single oral dose of rivaroxaban administered under fasting conditions 2\*5 mg tablet in first intervention period and 1\*10 mg tablet in second intervention period (after washout period) arm 2: Single oral dose of rivaroxaban administered under fasting conditions 1\*10 mg tablet in first intervention period and ... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Single oral dose of rivaroxaban administered under fasting conditions 2\*5 mg tablet in first intervention period and 1\*10 mg tablet in second intervention period (after washout period) intervention 2: Single oral dose of rivaroxaban administered under fasting conditions 1\*10 mg tablet in first interv... | intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Rivaroxaban (Xarelto, BAY59-7939) | 1 | Mönchengladbach | North Rhine-Westphalia | Germany | 6.44172 | 51.18539 | 0 | NCT01436526 |
[
4
] | 405 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with del... | This is an open label (all people know the identity of the intervention), prospective (study following participants forward in time), non-randomized (the study drug is not assigned by chance, participants may choose which group they want to be in, or they may be assigned to the groups by the researchers), single-arm (g... | Schizophrenia | Schizophrenia Paliperidone extended-release tablets | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Paliperidone Extended Release (ER) 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks. | intervention 1: Paliperidone ER | 0 | null | 0 | NCT01541371 |
[
3
] | 12 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | null | An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function | null | Pharmacokinetics Renal Impaired Healthy Volunteer | LCZ696 pharmacokinetics | null | 2 | arm 1: once daily administration of 400 mg LCZ696 for 5 days arm 2: once daily administration of 400 mg LCZ696 for 5 days | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: once daily administration of 400 mg LCZ696 for 5 days | intervention 1: LCZ696A intervention 2: LCZ696A | 3 | Neuss | N/A | Germany | 6.68504 | 51.19807
Moscow | N/A | Russia | 37.61556 | 55.75222
Belgrade | N/A | Serbia | 20.46513 | 44.80401 | 0 | NCT01569828 |
[
5
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial d... | a.Procedures: NAS scoring is currently done on infants meeting the inclusion criteria \[IDD 29:070\]. NAS scores are initially done every 2 hours for 24 hours and then every 4 hours when awake or before feeding for the duration of observation or treatment.
i. NAS scores may indicate more than withdrawal. Conditions su... | Neonatal Abstinence Syndrome | Neonatal Abstinence Syndrome Methadone Diluted Deodorized Tincture of Opium dDTO Phenobarbital | null | 2 | arm 1: The following is a dosing guide for methadone:
1. The neonatal concentration is 1 mg/ml of methadone. It is administered orally every 12 hours.
2. For the first 24 hours, doses will be prescribed every 6 hours using a sliding scale in response to the last NAS score:
NAS Score Methadone dose 8-11 0.05 mg/kg/... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Concentration is 1mg/mL administered every 12 hours given on sliding scale in response to last NAS score. intervention 2: Concentration is 1:24 dilution for a concentration of 0.4% | intervention 1: Methadone intervention 2: Diluted Deodorized Tincture of Opium | 1 | Bangor | Maine | United States | -68.77265 | 44.79884 | 0 | NCT01723722 |
[
2,
3
] | 69 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is ... | null | Breast Cancer | null | 2 | arm 1: Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m\^... | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression intervention 2: 60 mg/m\^2 IV weekly; dose increased to 70 mg/m\^2, and subsequently 80 mg/m\^2, after 2 treatment cycles with no evidence of DLT until disease progression intervention 3: 40 mg/m\^2 IV weekly; d... | intervention 1: trastuzumab intervention 2: paclitaxel intervention 3: Myocet | 1 | Madrid | N/A | Spain | -3.70256 | 40.4165 | 0 | NCT02015676 | |
[
4
] | 165 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superio... | null | Migraine Disorders Heart Disease Cerebrovascular Accident TIA (Transient Ischemic Attack) Vascular Diseases Peripheral Vascular Diseases | null | 2 | arm 1: Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up ... | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Telcagepant (MK-0974) (300 mg soft gel capsules or 280 mg tablets) intervention 2: Acetaminophen/Paracetamol (500 mg X 2 dosage units) intervention 3: Placebo 300 mg soft gel capsules or placebo 280 mg tablet. intervention 4: Placebo to acetaminophen/paracetamol (500 mg X 2 dosage units) | intervention 1: Telcagepant intervention 2: Acetaminophen/Paracetamol intervention 3: Placebo to Telcagepant intervention 4: Placebo to Acetaminophen/Paracetamol | 0 | null | 0 | NCT00662818 | |
[
5
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin. | null | Diabetes Mellitus Non-insulin-dependent | null | 1 | arm 1: sitagliptin | [
0
] | 1 | [
0
] | intervention 1: Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks | intervention 1: sitagliptin | 0 | null | 0 | NCT00832624 | |
[
3
] | 194 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This was a 2-part study of dexpramipexole in patients with ALS.
Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of dexpramipexole vs. placebo for 12 weeks.
Part 2 was a randomized, double-blind, 2-arm,... | This study was a two-part, multicenter, double-blind study in subjects with ALS to evaluate the safety and tolerability of dexpramipexole treatment, as well as the preliminary effects on measures of clinical function and mortality of dexpramipexole treatment.
In part 1, 102 subjects with ALS were randomized at 20 US s... | Amyotrophic Lateral Sclerosis | ALS Amyotrophic Lateral Sclerosis Lou Gehrig Lou Gehrig's Lou Gehrig's disease Motor Neuron Disease Nervous System Diseases KNS-760704 BIIB050 | null | 3 | arm 1: During Part 1, subjects received twice daily doses of dexpramipexole (50 mg/day, 150 mg/day, or 300 mg/day) or matching placebo for approximately 12 weeks. arm 2: At the beginning of Part 2, subjects received twice daily doses of placebo for approximately 4 weeks. arm 3: Following the Part 2 placebo washout, sub... | [
2,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Placebo: 2 tablets taken orally twice daily intervention 2: Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily intervention 3: Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily intervention 4: Dexpramipexole: 2 x 75 mg tablets taken orally twice daily | intervention 1: Placebo intervention 2: Dexpramipexole 50 mg/day intervention 3: Dexpramipexole 150 mg/day intervention 4: Dexpramipexole 300 mg/day | 21 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Aurora | Colorado | United States | -104.83192 | 39.72943
Miami | Florida | United States | -80.19366 | 25.77427
Kansas City |... | 0 | NCT00647296 |
[
4
] | 829 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a stan... | null | Ulcerative Colitis | null | 2 | arm 1: Mesalazine arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 2.4 g/day Once Daily (QD) intervention 2: 1.6g/day administered 800 mg Twice Daily (BID) | intervention 1: SPD476 intervention 2: Asacol | 142 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Bristol | Connecticut | United States | -72.94927 | 41.67176
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Hollywood | Florida | United States | -80.14949 | 26.0112
Jacksonville | Florida | United States | -81.65565 | 30.33218
N... | 0 | NCT00151892 | |
[
3
] | 42 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months. | null | Macular Degeneration | age-related macular degeneration (AMD) choroidal neovascularization (CNV) vascular endothelial growth factor (VEGF) pazopanib angiogenesis | null | 3 | arm 1: eligible participants received 5 mg/ml Pazopanib eye drops three times daily (TID) arm 2: eligible participants received 2 mg/ml Pazopanib eye drops three times daily arm 3: eligible participants received 5 mg/ml Pazopanib eye drops once daily (QD) | [
0,
0,
0
] | 1 | [
0
] | intervention 1: 5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD | intervention 1: Pazopanib | 17 | Beverly Hills | California | United States | -118.40036 | 34.07362
Sacramento | California | United States | -121.4944 | 38.58157
Winter Haven | Florida | United States | -81.73286 | 28.02224
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann ... | 0 | NCT00733304 |
[
5
] | 132 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose o... | null | Anemia | null | 1 | arm 1: Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta \[Mircera\] intravenously (IV) \[(120, 200 or 360 micrograms (mcg)\] every 4 weeks for 12 weeks. | [
0
] | 1 | [
0
] | intervention 1: iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks. | intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera] | 17 | New Delhi | National Capital Territory of Delhi | India | 77.2148 | 28.62137
Bangalore | N/A | India | 77.59369 | 12.97194
Bangalore | N/A | India | 77.59369 | 12.97194
Chennai | N/A | India | 80.27847 | 13.08784
Chennai | N/A | India | 80.27847 | 13.08784
Chennai | N/A | India | 80.27847 | 13.08784
Guwahati | N/A | In... | 0 | NCT00737464 | |
[
3
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this study is to compare the effect and safety of rHuPH20 or placebo for the prevention and treatment of skin allergic reaction to nickel. The study drug and placebo will be administered by intradermal injection. | This study will involve 2 regimens which will run in parallel. Each participant's upper back will be divided into 2 equal spaces for Regimen 1 and 2. Each of the 4 treatment sites in each space will be independently randomized to placebo or rHuPH20 treatment in a 1:1 ratio. Thus, each participant will serve as their ow... | Dermatitis, Allergic Contact | rHuPH20 Recombinant Human hyaluronidase | Prot_000.pdf:
Halozyme Therapeutics, Inc.
Protocol HALO-114-201
CONFIDENTIAL
Page 1 of 53
Version 1.0 27 May 2009
CLINICAL TRIAL PROTOCOL
Title:
A Prospective, Randomized, Double-blind, Placebo-controlled,
Single-center Study of the Intradermal Injection of rHuPH20
or Placebo in Subjects with Nickel Allergic ... | 2 | arm 1: Participant's upper back will be divided into 2 equal spaces and will receive Regimen 1 and 2 in 4 spaces respectively. In Regimen 1, a single row of 4 patches, each with the nickel sulfate concentration (NSC) (1, 2.5, or 5%) determined at screening, will be applied to the upper space at Day 1. After 48 hours, t... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 0.25 milliliter (mL) Intradermal (ID) syringe push bolus injection of rHuPH20 intervention 2: 0.25 mL ID syringe push bolus injection of placebo control | intervention 1: rHuPH20 intervention 2: Placebo | 1 | Michigan City | Indiana | United States | -86.89503 | 41.70754 | 0 | NCT00928447 |
[
4
] | 307 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | The purpose of this research study is to investigate whether or not oral maribavir is safe and effective compared to oral ganciclovir for preventing CMV disease when administered for up to 14 weeks in patients who have had a liver 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 | cytomegalovirus CMV prophylaxis liver liver transplant | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 100mg twice a day for 14 weeks. intervention 2: 1000mg three times per day for 14 weeks. | intervention 1: maribavir intervention 2: ganciclovir | 55 | Phoenix | Arizona | United States | -112.07404 | 33.44838
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | California | United States | -122.41942 | 37.77493
Stan... | 0 | NCT00497796 |
[
3
] | 120 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m\^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malig... | null | Glioma Astrocytoma Oligodendroglioma Glioblastoma | null | 1 | arm 1: Temozolomide will be administered at a dose of 50 mg/m\^2 for cycles of 28 days for 12 months or until progression. | [
0
] | 1 | [
0
] | intervention 1: Subjects will receive temozolomide 50 mg/m\^2 for cycles of 28 days for 12 months or until progression | intervention 1: Temozolomide | 0 | null | 0 | NCT00392171 | |
[
3
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study evaluated the safety and efficacy of LBH589B in adult participants with refractory/resistant Cutaneous T-Cell Lymphoma and prior Histone Deacetylase (HDAC) inhibitor therapy. | null | Cutaneous T-Cell Lymphoma | Cutaneous T-Cell Lymphoma adults Mycosis Fungoides Sézary Syndrome CTCL | null | 1 | arm 1: Participants received panobinostat, 20 milligrams (mg), capsules, orally, thrice weekly on alternate Days 1, 3, and 5 per week of a 28-day treatment cycle until unacceptable toxicity, disease progression, and/or physician's discretion to discontinue the treatment. | [
0
] | 1 | [
0
] | intervention 1: Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly. | intervention 1: Panobinostat | 18 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Aurora | Colorado | United States | -104.83192 | 39.72943
Miami | Florida | United States | -80.19366 | 25.77427
Augusta | Georgia | United States | -81.97484 | 33.47097
Chicago | Illinois | Unit... | 0 | NCT00490776 |
[
2,
3
] | 9 | NON_RANDOMIZED | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | true | This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can... | All patients will receive the 2 courses of chemotherapy unless medical complications prevent the administration of some of the drugs. Treatment for the first 2 courses of therapy will last about 2 months.
Treatment on this study will consist of a combination of 8 anti-cancer medications. The 8 anticancer medicines are... | Recurrent Pediatric ALL Relapsed Pediatric ALL Acute Lymphoblastic Leukemia Refractory Pediatric ALL | Acute Lymphoblastic Leukemia Pediatrics Relapsed Recurrence ABT-751 Therapeutic Advances in Childhood Leukemia Investigational Childhood ALL Relapsed ALL Refractory ALL Relapsed pediatric ALL Refractory pediatric ALL TACL | null | 7 | arm 1: Treatment Dose of ABT-751 is 80 mg/m2/day
Tx Course 1:
• ABT-751, Dexamethasone, PEG-asparaginase, Doxorubicin, Cytarabine, IT Methotrexate
Tx Course 2:
• Cyclophosphamide, 6-Thioguanine, IT Methotrexate, Cytarabine, PEG-asparaginase, ABT-751
Tx Courses 3-12 (maintenance courses):
• ABT-751, IT Methotrexat... | [
0,
0,
0,
0,
0,
0,
0
] | 8 | [
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Treatment Course 1:
Oral capsule to be given daily for 21 days at assigned dose.
Treatment Course 2:
ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.
Treatment Course 3:
ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week o... | intervention 1: ABT-751 intervention 2: Dexamethasone intervention 3: PEG-asparaginase intervention 4: Doxorubicin intervention 5: Cytarabine intervention 6: Methotrexate intervention 7: Cyclophosphamide intervention 8: 6-thioguanine | 5 | Los Angeles | California | United States | -118.24368 | 34.05223
Palo Alto | California | United States | -122.14302 | 37.44188
San Francisco | California | United States | -122.41942 | 37.77493
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00439296 |
[
3
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is an open-label, multicenter study to assess the systemic exposure to calcitriol in the adolescent population. Calcitriol 3µg/g ointment (2 mg/cm² per application) is to be applied twice daily to involved skin (10 - 35% BSA involved, excluding face, scalp and intertriginous areas) for 56 days (8 weeks). Full Phar... | null | Chronic Plaque Psoriasis | Calcitriol Psoriasis PK Adolescents | null | 1 | arm 1: Participants receive calcitriol 3 micrograms per gram (mcg/g) ointment applied topically twice daily for 56 days. | [
0
] | 1 | [
0
] | intervention 1: Calcitriol 3mcg/g ointment applied twice daily for 56 weeks. | intervention 1: Calcitriol 3mcg/g | 7 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
San Diego | California | United States | -117.16472 | 32.71571
Eagan | Minnesota | United States | -93.16689 | 44.80413
Houston | Texas | United States | -95.36327 | 29.76328
Webster | Texas | United States | -95.11826 | 29.53773
St. John's | Newfoundland an... | 0 | NCT00419666 |
[
2,
3
] | 66 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics | Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though side effects have been reported. New asthma medications, includin... | Asthma | Asthma alternative medicine complementary medicine herbal therapy | null | 3 | arm 1: ASHMI 4 capsules twice a day arm 2: ASHMI 12 capsules twice a day arm 3: Placebo 6 capsules twice a day | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 4 capsules orally twice a day intervention 2: 12 capsules orally twice a day intervention 3: Placebo 6 capsules twice a day | intervention 1: ASHMI 4 intervention 2: ASHMI 12 intervention 3: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00712296 |
[
2
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 2MALE | false | The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least one dose of MK-1064 that is generally safe and well t... | Two panels (Panels A and B), will receive alternating single rising oral doses of MK-1064/placebo (i.e., order of administration will be Panel A 5 mg, Panel B 10 mg, Panel A 25 mg, Panel B 50 mg, and continuing in this alternating sequence). Following dosing for a given treatment period, a minimum of 3 days will elapse... | Pharmacokinetics | null | 11 | arm 1: Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant. arm 2: Within each of up to 4 treatment periods, 6 participants were randoml... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths) intervention 2: Dose for each period administered as oral placebo tablets matching active MK-1064 tablets | intervention 1: MK-1064 intervention 2: Placebo | 0 | null | 0 | NCT02549014 | |
[
5
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone. | We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments that those who did not. There are also some scientific studies that included physical exercise in the treatment for panic disorder and compared them to other s... | Panic Disorder | Panic disorder Exercise Alprazolam Aerobic | null | 2 | arm 1: Patients assigned to the pharmacological plan arm 2: Patients assigned to mix plan | [
1,
1
] | 2 | [
0,
0
] | intervention 1: The patients assigned to the pharmacological plan will receive 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they have their first baseline psychiatric control, where all the patients are tested.
Then, at the same visit, all the patients are indicated 4 mg of alprazolam. The d... | intervention 1: Alprazolam intervention 2: Alprazolam + Aerobic exercise | 1 | Buenos Aires | Buenos Aires F.D. | Argentina | -58.37723 | -34.61315 | 0 | NCT00803400 |
[
4
] | 1,250 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.
Long Term Ext... | null | Rheumatoid Arthritis | null | 3 | arm 1: Short Term: Abatacept was dosed by weight with participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. Participants continued treatment with methotrexate (MTX) either orally or parenterally at a mini... | [
0,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Intravenous (IV) Solution, - Weight Titered (500 mg \< 60 kg); (750 mg 60-100 kg), )1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year intervention 2: Tablets, Oral, \>= 15 mg, weekly, 1 year intervention 3: IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days ther... | intervention 1: Abatacept intervention 2: Methotrexate intervention 3: Placebo | 48 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Corona | California | Unit... | 1 | NCT00048568 | |
[
4
] | 1,795 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications. | This was a multinational, multicenter, randomized, double-blind, 2-arm, parallel-dosing designed study. The treatment period was 12 months. Eligible participants were randomized to 1 of 2 treatment groups: abatacept fixed dose approximating 10 mg/kg (based on participant's body weight; 500 mg for participants weighing ... | Rheumatoid Arthritis | null | 3 | arm 1: Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants ... | [
1,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Concentrate and diluted in a solution, IV, 500 mg (body weight \< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \> 100 Kg), Once daily, Day 1, 15, and 29. intervention 2: Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29. intervention 3: Concentrate and dilute... | intervention 1: Double-blind Abatacept intervention 2: Double-blind Placebo intervention 3: Open-label Abatacept | 44 | Decatur | Alabama | United States | -86.98334 | 34.60593
Paradise | Arizona | United States | -109.21895 | 31.93481
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
San Francisco | California | United States | -122.41942 | 37.77493
Loveland | Colorado | ... | 1 | NCT00048932 | |
[
4
] | 1,783 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to diseas... | Melanoma accounts for approximately 5% of all skin cancers in the United States, but it accounts for about 75% of all skin cancer deaths. In 2004, the expected prevalence of melanoma is 627,252, with about 119,178 of these cases being Stage III or IV (metastatic melanoma). First line treatments for metastatic melanoma,... | Melanoma Metastases | melanoma metastatic melanoma skin cancer | null | 3 | arm 1: Melanoma Peptide Vaccine (MDX-1379) (gp100) + Placebo arm 2: MDX-010 (ipilimumab) + MDX-1379 (gp100) (Melanoma Peptide Vaccine) arm 3: MDX-010 (ipilimumab) + Placebo | [
1,
0,
1
] | 2 | [
0,
2
] | intervention 1: 3mg/kg (intravenous \[iv\] infusion over 90 minutes), every 3 weeks for 4 doses intervention 2: 2mL (2 subcutaneous injections of 2 mL each, 1 to each thigh), every 3 weeks for 4 doses. | intervention 1: MDX-010 (anti-CTLA4) monoclonal antibody intervention 2: MDX-1379 (gp100) Melanoma Peptide Vaccine | 209 | Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Duarte | California | United States | -117.97729 | 34.13945
Encinitas | California | United States | -117.29198 | 33.03699
La Jolla | California | United States | -117.2742 | 32.84727
La Jolla | California ... | 1 | NCT00094653 |
[
4
] | 9,306 | RANDOMIZED | FACTORIAL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline... | null | Diabetes Mellitus, Type 2 | Prevention Diabetes type 2 valsartan nateglinide | null | 4 | arm 1: For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily, ante cibum \[ac\] before meals) and valsartan 80 mg (once daily \[od\] in the morning). After 2 weeks, patients were up-titrated to nateglinide 60 mg ac and valsartan 160 mg od. arm 2: For the first 2 weeks of ... | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: The double-blinding of the randomized study medication was maintained by the use of identical placebo and active tablets and capsules for nateglinide and valsartan, respectively. Patients were instructed not to take the morning dose of either medication nor to eat breakfast on the day of a scheduled stu... | intervention 1: Valsartan 160 mg + nateglinide 60 mg intervention 2: Valsartan 160 mg + nateglinide placebo intervention 3: Nateglinide 60 mg + valsartan placebo intervention 4: Valsartan placebo + nateglinide placebo | 38 | Multiple Locations | New Jersey | United States | N/A | N/A
Investigative Site | N/A | Argentina | N/A | N/A
Investigative Site | N/A | Australia | N/A | N/A
Multiple Locations | N/A | Austria | N/A | N/A
Investigative Site | N/A | Belgium | N/A | N/A
Investigative Site | N/A | Brazil | N/A | N/A
Investigative Site | N... | 1 | NCT00097786 |
[
4
] | 225 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Respo... | This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone versus DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with new... | Multiple Myeloma | Multiple myeloma Newly diagnosed multiple myeloma Thalidomide Dexamethasone DOXIL Pegylated liposomal hydrochloride doxorubicin injection | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered f... | intervention 1: Thalidomide intervention 2: Dexamethasone intervention 3: DOXIL | 58 | Fountain Valley | California | United States | -117.95367 | 33.70918
Greenbrae | California | United States | -122.5247 | 37.94854
La Verne | California | United States | -117.76784 | 34.10084
Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Colorado | United States | -104.9847 | 39.73915
New L... | 1 | NCT00097981 |
[
4
] | 1,553 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).
Study participants ... | null | Attention Deficit Hyperactivity Disorder | null | 1 | arm 1: Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose. | [
0
] | 1 | [
0
] | intervention 1: 0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years | intervention 1: atomoxetine | 100 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
El Centro | California | United States | -115.56305 | 32.792
Irvine | California | United States | -117.82311 | 33.66946
Lafayette | California | United States | -122.11802 | 37.88576
Los Angeles | Cali... | 1 | NCT00190684 | |
[
5
] | 502 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of at... | The initial study was 34 weeks long; however, the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks (38 weeks total). | Attention Deficit Hyperactivity Disorder | null | 2 | arm 1: Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally arm 2: Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally intervention 2: Placebo is administered QD, orally for 24 weeks. At the end of 24 weeks, the placebo arm is ... | intervention 1: Atomoxetine Hydrochloride intervention 2: Placebo | 21 | Irvine | California | United States | -117.82311 | 33.66946
Gainesville | Florida | United States | -82.32483 | 29.65163
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Libertyville | Illinois | United States | -87.95313 | 42.28308
Indianapolis | Indiana | U... | 1 | NCT00190775 | |
[
5
] | 1,270 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate. | null | Bipolar Disorder | Bipolar I Disorder with a recent manic or mixed episode | null | 2 | arm 1: /Active Comparator arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, once daily
lithium 250-2100 mg/day
valproate 250-2500mg/day
Placebo once daily intervention 2: Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks)
lithium 250-2100 mg/day
valproate 250-2500mg/day
aripiprazole 15-30 mg/day | intervention 1: Lithium or Valproate with placebo (PBO) intervention 2: Lithium or Valproate with Aripiprazole | 83 | Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Anaheim | California | United States | -117.9145 | 33.83529
Cerritos | California | United States | -118.06479 | 33.85835
Costa Mesa | California | United States | -117.91867 | 33.64113
Costa Mesa | California | United States | -117.91867 | 33.64113
Long Beach... | 1 | NCT00261443 |
[
5
] | 566 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a randomized, multi-center, parallel-group, active-controlled, double-blind study evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the averaged baseline value (the average of the two... | null | Asthma | null | 4 | arm 1: MF DPI 400 mcg once a day (QD) in the evening (PM) arm 2: MF DPI 200 mcg QD PM arm 3: Fluticasone propionate (FP) metered dose inhaler (MDI) 250 mcg twice a day (BID) arm 4: ML 10 mg QD PM | [
0,
0,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year. intervention 2: 200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year. intervention 3: 250 mcg FP... | intervention 1: mometasone furoate dry powder inhaler intervention 2: mometasone furoate dry powder inhaler intervention 3: fluticasone propionate hydrofluoroalkane (HFA) intervention 4: montelukast | 0 | null | 1 | NCT00394355 | |
[
5
] | 1,531 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors. | null | Hypertension Hypercholesterolemia | null | 1 | arm 1: Open label caduet added to usual care regimen followed by investigators. | [
0
] | 1 | [
0
] | intervention 1: Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion | intervention 1: Amlodipine besylate/atorvastatin calcium single pill combination | 125 | Desamparados | Provincia de San José | Costa Rica | -84.06345 | 9.89747
Heredia | N/A | Costa Rica | -84.11587 | 9.99872
San José | N/A | Costa Rica | -84.08489 | 9.93388
Breznički Hum | N/A | Croatia | 16.27667 | 46.10722
Crikvenica | N/A | Croatia | 14.69278 | 45.17722
Čakovec | N/A | Croatia | 16.43389 | 46.38444
Ka... | 1 | NCT00407537 | |
[
4
] | 308 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy | null | Partial Epilepsies | Adjunctive treatment in epilepsy add-on treatment for epilepsy partial seizures AEDs antiepileptic drugs seizures | null | 1 | arm 1: Up to 800 mg/day lacosamide (flexible dosing) | [
0
] | 1 | [
0
] | intervention 1: 50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial | intervention 1: lacosamide | 60 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
San Francisco | Cal... | 1 | NCT00522275 |
[
3
] | 40 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 y... | null | Candidiasis Candidemia | Open-Label Pharmacokinetics Intravenous to oral switch Safety Voriconazole Immunocompromise Children High Risk For Systemic Fungal Infection. | null | 1 | arm 1: Immunocompromised children aged 2 to \<12 years who are at high risk for systemic fungal infection. | [
0
] | 1 | [
0
] | intervention 1: Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h
Notes:
1. If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
2. Only morning oral dose will be given on Day 14 (or ... | intervention 1: voriconazole (Vfend) | 14 | Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Orange | California | United States | -117.85311 | 33.78779
Jacksonville | Florida | United States | -81.65565 | 30.33218
Atlanta | Georgia | United States | -84.38798 | 33.749
Atlanta | Georgia | United St... | 1 | NCT00739934 |
[
4
] | 565 | RANDOMIZED | FACTORIAL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | false | Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women | The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:
G-ER 1200mg daily (single evening dose)
G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg PM)
compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashe... | Hot Flashes | Hot Flashes Hot Flushes Postmenopausal symptoms Vasomotor symptoms | null | 3 | arm 1: Gabapentin extended-release (G-ER) 1200 mg arm 2: Gabapentin extended-release (G-ER) 1800 mg arm 3: Placebo 1200 mg or 1800 mg | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: G-ER 1200 mg daily dosage given as two 600-mg tablets. intervention 2: G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening. intervention 3: Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the mor... | intervention 1: Gabapentin Extended-Release (G-ER) 1200 mg intervention 2: Gabapentin Extended-Release (G-ER) 1800 mg intervention 3: Placebo | 45 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Chandler | Arizona | United States | -111.84125 | 33.30616
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Foothill Ranch | California | United States | -117.66088 | 33.68641
San Diego ... | 1 | NCT00777023 |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Vitamin D in the diet undergoes changes in the liver and kidneys to several forms. Patients suffering from disorders with Vitamin D resistance are unable to absorb calcium from food. Patients diagnosed with these disorders will be evaluated and treated with high doses of another form of Vitamin D (1,25-dihydroxyvitamin... | Patients with extreme resistance to 1,25-dihydroxyvitamin D will be evaluated and treated with high doses of 1,25-dihydroxyvitamin D3.
Plan: In previously untreated patients the study will be divided into a control and one or more treatment periods. During the control period, parathyroid status will be assessed by par... | Hypocalcemia Rickets | Calciferol Hypocalcemia Rickets | null | 1 | arm 1: 1,25-Dihydroxycholecalciferol 5 ug orally per day for 2 years | [
0
] | 1 | [
0
] | intervention 1: Usual doses of 1,25-dihydroycholecalciferol are 0.25-1 ug per day. All patients in this study received very high doses or 5-20 ug per day. | intervention 1: 1,25-Dihydroxycholecalciferol | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00001151 |
[
4
] | 1,050 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | The HALT-C Trial is a National Institute of Diabetes and Digestive and Kidney Diseases sponsored, randomized clinical trial of long-term use of Peginterferon alfa-2a (pegylated interferon) in patients who failed to respond to prior interferon treatment. All patients who enter the trial will be treated for 6 months with... | null | Chronic Hepatitis c Cirrhosis, Liver Fibrosis, Liver Hepatic Cirrhosis | liver disease hepatitis c virus antiviral agent cirrhosis | null | 2 | arm 1: Peg-interferon alfa-2a 90 mcg/week arm 2: Standard of care followup | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Peginterferon alfa-2a 180 mcg/week injection, for 24 weeks, plus 1000-1200 mg Ribavirin oral (prescribed according to weight \<75 kg, \>75 kg) daily in two divided doses for 24 weeks intervention 2: 90 mcg/week injection, for 3.5 years | intervention 1: Peginterferon alfa-2a + Ribavirin intervention 2: Peginterferon alfa-2a | 11 | Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Colorado | United States | -104.9847 | 39.73915
Farmington | Connecticut | United States | -72.83204 | 41.71982
Bethesda | Maryland | United States | -77.10026 | 38.98067
Boston | Ma... | 0 | NCT00006164 |
[
4
] | 208 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve).... | null | Breast Cancer | null | 2 | arm 1: Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase. arm 2: 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 4mg/kg iv loading dose, followed by 2mg/kg iv weekly intervention 2: 1 mg tablet taken orally daily | intervention 1: trastuzumab (Herceptin®) intervention 2: anastrazole (Arimidex®) | 132 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Los Angeles | California | United States | -118.24368 | 34.05223
Vallejo | California | United States | -122.25664 | 38.10409
Gainsville | Florida | United States | N/A | N/A
Miami | Florida | United ... | 0 | NCT00022672 | |
[
3
] | 97 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells.
PURPOSE: Randomized phase II trial t... | OBJECTIVES:
* Compare the pathologic complete response rate in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with radiotherapy with pre- and post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan.
* Compare the survival outcome in patients treated with these regi... | Esophageal Cancer Gastric Cancer | stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus | null | 2 | arm 1: Days 1 - 35 : Concurrent radiation therapy (RT) and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy
D... | [
0,
0
] | 5 | [
0,
0,
0,
3,
4
] | intervention 1: Days 1 - 35 : Cisplatin 30 mg/m² days 1, 8, 15, 22, 29
Days 63 - 77 : cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles intervention 2: Days 1 - 35 : Irinotecan 65 mg/m² days 1, 8, 22, 29
Days 63 - 77 : irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles intervention 3... | intervention 1: cisplatin intervention 2: irinotecan hydrochloride intervention 3: paclitaxel intervention 4: conventional surgery intervention 5: radiation therapy | 23 | Denver | Colorado | United States | -104.9847 | 39.73915
Newark | Delaware | United States | -75.74966 | 39.68372
Gainesville | Florida | United States | -82.32483 | 29.65163
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Urbana | Illinois | United St... | 0 | NCT00033657 |
[
3
] | 108 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be... | null | Breast Neoplasms | breast neoplasms | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Letrozole 2.5 mg daily + Temsirolimus (CCI-779) 10 mg daily intervention 2: Letrozole 2.5 mg daily + Temsirolimus (CCI-779) intermittent 30 mg daily for five days every 2 weeks intervention 3: Letrozole 2.5 mg daily | intervention 1: Letrozole / Temsirolimus (CCI-779) intervention 2: Letrozole / Temsirolimus (CCI-779) intervention 3: Letrozole | 0 | null | 0 | NCT00062751 |
[
3
] | 56 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as vinorelbine, work in different ways to s... | OBJECTIVES:
Primary
* Determine the efficacy of multiepitope autologous dendritic cell vaccine, trastuzumab (Herceptin\^®), and vinorelbine by measuring the change in the largest dimension of metastatic lesions, in women with locally recurrent or metastatic breast cancer that does not overexpress human epidermal grow... | Breast Cancer | recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer | null | 1 | arm 1: Dendritic Cells: Dosage: 20 x 106 dendritic cells (DCs) given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly | [
0
] | 3 | [
2,
2,
0
] | intervention 1: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and ... | intervention 1: therapeutic autologous dendritic cells intervention 2: trastuzumab intervention 3: vinorelbine ditartrate | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00088985 |
[
3
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | The purpose of this study is to compare the progression-free survival of two treatment regimens for relapsed ovarian cancer. | Primary Objective
The primary objective of the study is to compare the progression-free survival of two treatment regimens:
Taxotere® 30 mg/m2 IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression. (A patient who has completed 6 cycles of tre... | Ovarian Cancer | Relapsed ovarian cancer | null | 2 | arm 1: Docetaxel 30mg/m2 mg IV on Days 1 and 8, in combination with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression arm 2: Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression. Once subjects have completed 6 cycles of docetaxel... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: For Arm 1: 30mg/m2 mg IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression combined with carboplatin
For Arm 2: 30mg/m2 IV on Days 1 and 8 repeated every 21 days for six cycles until disease progression followed by carboplatin intervention 2: Arm 1: AUC 6 IV on Days 1 and ... | intervention 1: Docetaxel intervention 2: Carboplatin | 19 | Fort Myers | Florida | United States | -81.84059 | 26.62168
Jupiter | Florida | United States | -80.09421 | 26.93422
Orlando | Florida | United States | -81.37924 | 28.53834
Bettendorf | Iowa | United States | -90.51569 | 41.52448
Iowa City | Iowa | United States | -91.53017 | 41.66113
Baltimore | Maryland | United Sta... | 0 | NCT00090610 |
[
3
] | 172 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain. | This is a 6-month randomized, double-blind, placebo controlled trial of 25 mg naltrexone for smoking cessation in a sample of 270 male and female weight-concerned smokers. Participants also receive transdermal nicotine replacement therapy during the first 8 weeks of the study, which they begin on their quit date. Naltr... | Nicotine Dependence | Tobacco Smoking Weight Weight perception Naltrexone | null | 2 | arm 1: Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day arm 2: Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day... | [
0,
2
] | 3 | [
0,
0,
5
] | intervention 1: Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks intervention 2: Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day intervention 3: Brief behav... | intervention 1: Naltrexone intervention 2: Transdermal nicotine replacement intervention 3: Behavioral counseling | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00105482 |
[
2,
3
] | 14 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to find out if patients with high risk disease because of age or kidney status can be treated more safely with a drug called Busulfex® followed by autologous transplant compared to treatment with the standard drug called melphalan, which has been shown to be quite difficult to tolerate in p... | This trial will determine the maximal dose of Busulfex® that can be given in a two, three, or four day period with acceptable toxicity to myeloma patients, who either are \> or = 65 years of age or have renal insufficiency, defined as creatinine \> 3g/dL or creatinine clearance \< 30 ml/min. | Multiple Myeloma | Myeloma, MM | null | 1 | arm 1: study-specific treatment: Busulfex according to study design: Level I 3.2 mg/kg over 6 hours x 2 days Level II 3.2 mg/kg over 6 hours x 3 days Level III 3.2 mg/kg over 6 hours x 4 days Level IV 4.3 mg/kg over 6 hours x 3 days Level V 5.6 mg/kg over 6 hours x 2 days Level VI 6.4 mg/kg over 6 hours x 2 days | [
0
] | 1 | [
0
] | intervention 1: Dexamethasone 40 mg PO 1-4 Thalidomide 200 mg PO 1-6 Cisplatin\* 10 mg/m, Continuous infusion 1-4 Adriamycin\*\* 10 mg/m2, Continuous infusion 1-4 Cyclophosphamide 400 mg/2, Continuous infusion 1-4 Etoposide 40 mg/m2, Continuous infusion 1-4 All doses will be based on calculated body weight (actual weig... | intervention 1: Busulfan | 2 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 0 | NCT00113919 |
[
3
] | 88 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 2MALE | false | The purpose of the study is to assess the effects of sustained aromatase inhibitor therapy to reduce estrogen levels in elderly men with mild hypogonadism (a decreased level of sex hormones). | It has long been accepted that aging in men is associated with a slow, steady decline in gonadal androgen (male sex hormone) production. Several studies have explored androgen replacement, but the safety and efficacy of testosterone administration remains controversial. Aromatase inhibitors may provide a particularly u... | Hypogonadism | Aging | null | 2 | arm 1: anastrozole arm 2: placebo | [
0,
2
] | 1 | [
0
] | intervention 1: 1 mg QD | intervention 1: anastrozole | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00136695 |
[
2
] | 48 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide var... | null | Waldenstrom's Macroglobulinemia Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma | Hematological Proteasome Myeloma Lymphoma | null | 11 | arm 1: Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles. arm 2: Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Administered as an IV bolus dose intervention 2: Administered orally prior to carfilzomib | intervention 1: Carfilzomib intervention 2: Dexamethasone | 5 | Beverly Hills | California | United States | -118.40036 | 34.07362
Tampa | Florida | United States | -82.45843 | 27.94752
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00150462 |
[
5
] | 394 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The dev... | null | Renal Transplantation | Renal transplantation, everolimus, calcineurin inhibitors, GFR | null | 3 | arm 1: Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids arm 2: Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose. arm 3: Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001)... | [
1,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Everolimus (RAD001) intervention 2: Calcineurin Inhibitors (CNI) intervention 3: Mycophenolate acid (MPA)/Azathioprine (AZA) intervention 4: Steroids | 1 | Basel | N/A | Switzerland | 7.57327 | 47.55839 | 0 | NCT00170846 |
[
3
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Drugs used in chemotherapy, such as epirubicin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin together with vinorelbine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well gi... | OBJECTIVES:
* Assess the efficacy of sequential use of epirubicin hydrochloride followed by vinorelbine ditartrate in patients with stage IIB, IIIA, IIIB, or IV breast cancer.
* Measure the biological response to this regimen in sequential tumor biopsies and peripheral mononuclear cells from these patients.
* Correlat... | Breast Cancer | recurrent breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IV breast cancer male breast cancer | null | 1 | arm 1: For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of ca... | [
0
] | 2 | [
0,
0
] | intervention 1: Epirubicin (100 mg/m2) will be given on Day 1 intervention 2: Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17. | intervention 1: epirubicin intervention 2: vinorelbine | 1 | New Brunswick | New Jersey | United States | -74.45182 | 40.48622 | 0 | NCT00176488 |
[
4
] | 1,469 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from ... | Study M03-658 was a continuation study for participants with moderate to severe psoriasis who had participated in a prior psoriasis adalimumab study. Study M03-658 consisted of three sequential treatment periods. The first period was Period O, in which participants received open-label treatment with adalimumab (40 mg e... | Psoriasis | null | 1 | arm 1: None | [
5
] | 1 | [
0
] | intervention 1: 40 mg every other week or 40 mg every week by subcutaneous injection | intervention 1: adalimumab | 104 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Buckner 13075 PI | Alabama | United States | N/A | N/A
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Bakersfield | California ... | 0 | NCT00195676 | |
[
3
] | 53 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The standard treatment for non-small cell lung cancer, stage IV or IIIB malignant pleural effusion is chemotherapy. The decision to use a regimen is currently determined by toxicity or by physician's preference. In this protocol, the treatment regimen will be assigned based on the patients' tumor molecular profile. A t... | Evaluation at study entry will include blood tests, computerized tomography (CT) scans or other types of scans needed to measure other disease sites. A biopsy of one tumor is required for tumor analysis. If the patient's cancer has spread to other locations that may be easier to obtain tissue from and be less invasive,... | Carcinoma, Non-Small-Cell Lung | malignant pleural effusion | null | 1 | arm 1: Molecular Analysis-Directed Chemotherapy Assignment based on gene expression of ERCC1 and RRM1. | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Ribonucleotide reductase subunit 1(RRM1)above 16.5 and Excision repair cross-complementing group 1 gene(ERCC1)above 8.7: Treat patients with Docetaxel and Vinorelbine (DV). DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. intervention 2... | intervention 1: Vinorelbine intervention 2: Docetaxel intervention 3: Gemcitabine intervention 4: Carboplatin | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 0 | NCT00215930 |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | A study to determine the effect on renal function in renal transplant patients with biopsy proven Chronic allograft nephropathy (CAN) nephropathy who are switched from a Calcinerin inhibitor (CI) triple drug regimen to a Rapamycin based triple drug regimen or maintained on their CI protocol | null | Kidney Transplant | null | 2 | arm 1: pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin arm 2: Patient will remain on calcineruin inhibitor | [
1,
4
] | 1 | [
0
] | intervention 1: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15 | intervention 1: Rapamycin | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00223678 | |
[
3
] | 19 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells.
PURPOSE: This phase II tri... | OBJECTIVES:
Primary
* Determine the objective response rate in patients with stage IV breast cancer treated with gemcitabine hydrochloride and genistein.
Secondary
* Determine the duration of response and survival of patients treated with this regimen.
* Determine the time to disease progression in patients treated... | Breast Cancer | stage IV breast cancer recurrent breast cancer | Prot_SAP_000.pdf:
D-2597
Page 1 of 32
Karmanos Cancer Institute
Wayne State University
Phase II trial of gemcitabine and genistein in metastatic breast cancer patients,
with biomarker assays
PRINCIPAL INVESTIGATOR:
Amy M. Weise, D.O.
KARMANOS CANCER INSTITUTE
WAYNE STATE UNIVERSITY
4100 Joh... | 1 | arm 1: Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days. | [
0
] | 3 | [
7,
0,
3
] | intervention 1: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days. intervention 2: Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days intervention 3: Biopsy of tumor prior to dose of genistein (Novasoy) | intervention 1: genistein intervention 2: gemcitabine intervention 3: Tumor biopsy | 1 | Detroit | Michigan | United States | -83.04575 | 42.33143 | 0 | NCT00244933 |
[
5
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | false | To evaluate the efficacy, safety, and tolerability of combination therapy with intramuscular interferon beta-1a and oral doxycycline, a potent inhibitor of matrix metalloproteinases, in patients with relapsing remitting multiple sclerosis (RRMS) having breakthrough disease activity. | Eligible individuals were evaluated monthly for 3 months while taking intramuscular interferon beta-1a, 30 micrograms weekly, then monthly for 4 months while receiving intramuscular interferon beta-1a, 30 micrograms and oral doxycycline, 100 mg daily. | Multiple Sclerosis | null | 1 | arm 1: Interferon beta 1a, oral doxycycline | [
0
] | 1 | [
0
] | intervention 1: Patients took intramuscular interferon beta 1a, 30 micrograms, for 3 months then added oral doxycycline, 100 daily with the interferon for 4 months. | intervention 1: Interferon beta 1a, oral doxycycline | 1 | Shreveport | Louisiana | United States | -93.75018 | 32.52515 | 0 | NCT00246324 | |
[
4
] | 833 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant. | null | Kidney Transplantation Graft Rejection | Renal transplantation, kidney, and organ transplant Renal transplant rejection | null | 3 | arm 1: 1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.
The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-... | [
0,
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: oral, bis in diem/twice a day (bid) intervention 2: 2 oral capsules of mycophenolic acid 360mg administered bid intervention 3: CsA dose adjustments were based on CsA trough levels (C0). intervention 4: All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was t... | intervention 1: Everolimus intervention 2: Mycophenolic Acid (MPA) intervention 3: Cyclosporine A (CsA) intervention 4: Basiliximab intervention 5: Corticosteroids | 1 | East Hanover | New Jersey | United States | -74.36487 | 40.8201 | 0 | NCT00251004 |
[
4
] | 64 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | The purpose of this study is to test whether the drug, atorvastatin, will be able to reduce the rate of return of the abnormal beats after using cardioversion. Atorvastatin is a drug approved by the Food and Drug Administration (FDA) for the treatment of high cholesterol but is not approved for preventing abnormal hear... | Atrial fibrillation (AF) and its related disorder, atrial flutter (AFlut), are common abnormal heartbeats. Because they are similar and AFlut is rare compared to AF, they are usually treated similarly and discussed as one disorder. AF is an extremely common arrhythmia affecting more that 5% of the population over 65 ye... | Atrial Fibrillation Inflammation | Reactive Oxgen Speers Atrial Fibrillation Oxidative Stress Inflammation | null | 2 | arm 1: Placebo taken daily arm 2: Atorvastatin at a dose of 80 mg daily | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 80 mg of Atorvastatin intervention 2: None | intervention 1: Atorvastatin intervention 2: Placebo | 3 | Atlanta | Georgia | United States | -84.38798 | 33.749
Atlanta | Georgia | United States | -84.38798 | 33.749
Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00252967 |
[
2,
3
] | 60 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a peripheral stem cell transplant may be ... | OBJECTIVES:
Primary Phase
* Determine the best dose of treosulfan when administered with fludarabine as a reduced-intensity conditioning regimen followed by allogeneic hematopoietic stem cell transplantation, in terms of incidence of severe to fatal toxicity to major organ systems and incidence of graft failure, in p... | Leukemia Myelodysplastic Syndromes | adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia se... | null | 0 | null | null | 3 | [
0,
0,
3
] | intervention 1: 30 mg/m2, IV for 5 days intervention 2: 12 or 14 g/m2, IV for 5 days intervention 3: bone marrow or peripheral blood stem cells | intervention 1: fludarabine intervention 2: treosulfan intervention 3: allogeneic blood or bone marrow transplantation | 3 | Portland | Oregon | United States | -122.67621 | 45.52345
Seattle | Washington | United States | -122.33207 | 47.60621
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00253513 |
[
4
] | 86 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 2MALE | true | This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. ... | This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patients will be randomized to either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer.... | Prostate Neoplasm | Estrogen Receptor Isoflavones Prostate Neoplasm Soy Supplementation | null | 2 | arm 1: Placebo arm 2: Soy Supplement | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice). intervention 2: Placebo will consist of a capsule without the... | intervention 1: Soy Supplement intervention 2: Placebo | 1 | Kansas City | Missouri | United States | -94.57857 | 39.09973 | 0 | NCT00255125 |
[
4
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that leads to a decrease in the blood level of functional "C... | A prospectively planned interim analysis will be performed on the double-blind data. | Hereditary Angioedema Angioneurotic Edema Genetic Disorders | null | 2 | arm 1: 100 IU/kg recombinant human C1 inhibitor arm 2: Saline solution | [
0,
2
] | 2 | [
0,
0
] | intervention 1: IV intervention 2: IV | intervention 1: recombinant human C1 inhibitor intervention 2: Placebo | 2 | Leiden | N/A | Netherlands | 4.49306 | 52.15833
Târgu Mureş | N/A | Romania | 24.55747 | 46.54245 | 0 | NCT00262301 | |
[
3
] | 17 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase II study will test the response rate of combined oxaliplatin and capecitabine treatment when administered at a given dose and schedule, in patients with Head and Neck cancer for which there is no curative treatment. | The optimal dose and schedule for the combined treatment with oxaliplatin and capecitabine have not been defined. The aim of this Phase II study is to determine the response rate of combined oxaliplatin and capecitabine treatment at a given dose and schedule in patients with Head and Neck cancer for which there is no c... | Head or Neck Cancer | null | 1 | arm 1: Treatment with combination of oxaliplatin and capecitabine using study dose and schedule. | [
0
] | 1 | [
0
] | intervention 1: Agent, DOSE AND SCHEDULE (28-days cycle):
Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21 | intervention 1: Oxaliplatin, Capecitabine | 1 | Louisville | Kentucky | United States | -85.75941 | 38.25424 | 0 | NCT00266279 | |
[
5
] | 402 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The main objective of this study is to compare three strategies of evening insulin glargine dosing to preoperative glucose values in patients with diabetes undergoing surgery to determine which dosing strategies most often achieves the admission target study values of 100-179 mg/dl. | There are no evidence-based guidelines for insulin glargine (Lantus) dosing in the perioperative setting. Insulin glargine provides peakless 24-hour coverage of basal insulin needs for people with both Type 1 and Type 2 diabetes. Insulin glargine may be used as the sole insulin or in combination with other rapid-acting... | Diabetes Surgery | Diabetes Insulin Glargine Surgery | null | 3 | arm 1: Patients in Group 1 will administer 80% of their usual insulin glargine dose. arm 2: Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose. arm 3: Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percen... | [
0,
1,
0
] | 3 | [
0,
10,
0
] | intervention 1: Patients in Group 1 will administer 80% of their usual insulin glargine dose. intervention 2: Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose intervention 3: Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. W... | intervention 1: Lantus intervention 2: Insulin intervention 3: Lantus | 2 | Royal Oak | Michigan | United States | -83.14465 | 42.48948
Troy | Michigan | United States | -83.14993 | 42.60559 | 0 | NCT00309465 |
[
3,
4
] | 58 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer.
Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participant... | The study included:
* A Thirty (30)-day screening phase
* The double blind treatment period for a minimum of 60 days. Day 1 of the double-blind treatment period was defined as the date of the qualifying paracentesis (ie, withdrawal of \>= 1 Liter of ascitic fluid). Participants were randomized after adequate recovery ... | Ovarian Neoplasms Ascites | Ovarian neoplasm Ascites Angiogenesis inhibitor Vascular Endothelial Growth Factor A Recombinant fusion protein | null | 2 | arm 1: Participants with advanced ovarian cancer administered placebo in the double-blind (DB) period.
In the open-label (OL) period, participants had the option to receive aflibercept or be withdrawn from the study. arm 2: Participants with advanced ovarian cancer administered aflibercept in the double-blind (DB) per... | [
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: 4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period. intervention 2: Placebo was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period. intervention 3: 4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour on... | intervention 1: aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) intervention 2: Placebo intervention 3: aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) | 9 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Vienna | N/A | Austria | 16.37208 | 48.20849
Diegem | N/A | Belgium | 4.43354 | 50.89727
Laval | N/A | Canada | -73.692 | 45.56995
Budapest | N/A | Hungary | 19.04045 | 47.49835
Mumbai | N/A | India | 72.88261 | 19.07283
Netanya | N/A | Israel | 34.85992 |... | 0 | NCT00327444 |
[
5
] | 1,004 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting. | Anxiety disorders are highly prevalent, distressing, and disabling. Most patients with anxiety disorders who do receive mental health treatment receive it in primary care settings, where the quality of care is generally insufficient. This intervention is geared towards testing the clinical effectiveness of a care-manag... | Post-traumatic Stress Disorder Generalized Anxiety Disorder Panic Disorder Social Anxiety Disorder | Anxiety Disorders Post-traumatic Stress Disorder Generalized Anxiety Disorder Panic Disorder Social Anxiety Disorder Stress Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Mental Health Disorders | null | 2 | arm 1: Participant choice of:
Cognitive Behavioral Therapy (CBT) Psychotropic (anti-anxiety) medication optimization arm 2: Participants assigned to TAU with their primary care provider (PCP) | [
0,
1
] | 3 | [
5,
0,
5
] | intervention 1: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist. intervention 2: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to... | intervention 1: Cognitive-behavioral therapy intervention 2: Psychotropic medication optimization intervention 3: Treatment as Usual | 4 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00347269 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Giving chemotherapy drugs, such as busulfan, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of tumor cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marr... | OBJECTIVES:
* Evaluate disease-free and overall survival of patients with high-risk tumors of the Ewing's family treated with unmodified T-cell depleted allogeneic hematopoietic stem cell transplantation after cytoreduction comprising busulfan, melphalan, and thiotepa.
* Determine the regimen-related morbidity and mor... | Sarcoma | metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor | null | 1 | arm 1: * Myeloablative preparative regimen: Patients receive busulfan IV over 2 hours every 6 hours on days -8 to -6, melphalan IV over 20 minutes on days -5 to -3, and thiotepa IV over 4 hours on day -2.
* Allogeneic hematopoietic stem cell transplant: Patients undergo allogeneic bone marrow or T-cell depleted periphe... | [
0
] | 7 | [
2,
0,
0,
0,
3,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None | intervention 1: graft versus host disease prophylaxis/therapy intervention 2: busulfan intervention 3: melphalan intervention 4: thiotepa intervention 5: allogeneic bone marrow transplantation intervention 6: allogeneic hematopoietic stem cell transplantation intervention 7: peripheral blood stem cell transplantation | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00357396 |
[
4
] | 32 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.
... | This will be a multi-center, randomized, double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in 30 untreated patients with Gaucher disease. Patients will receive IV infusion of prGCD every two weeks at the selected medical center. The duration of the study will be nine months. At... | Gaucher Disease | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Intravenous infusion every two weeks for 9 months intervention 2: Intravenous infusion every 2 weeks for 9 months | intervention 1: Plant cell expressed recombinant glucocerebrosidase (prGCD) intervention 2: Plant cell expressed recombinant glucocerebrosidase (prGCD) | 11 | Coral Springs | Florida | United States | -80.2706 | 26.27119
Decatur | Georgia | United States | -84.29631 | 33.77483
New York | New York | United States | -74.00597 | 40.71427
Toronto | Ontario | Canada | -79.39864 | 43.70643
Santiago | N/A | Chile | -70.64827 | -33.45694
Haifa | N/A | Israel | 34.99928 | 32.81303
Je... | 0 | NCT00376168 | |
[
3
] | 64 | RANDOMIZED | FACTORIAL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine whether aspirin and simvastatin are safe and effective for the treatment of pulmonary arterial hypertension (PAH). | PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. In PAH, in situ thrombosis may occur in the lungs, and pulmonary endothelial dysfunction is well-recognized. As aspirin inhibits platelet aggregation, there may be value in using aspirin to treat PAH. Simvastatin has benef... | Hypertension, Pulmonary | Pulmonary Arterial Hypertension | null | 4 | arm 1: Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months
Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months arm 2: Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months
Placebo taken orally, once a day for 6 months arm 3: Placebo taken orally, once a day for 6 months
Simvastati... | [
1,
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Simvastatin 40 mg, taken orally, once a day for 6 months intervention 2: Aspirin 81 mg, taken orally, once a day for 6 months intervention 3: Placebo, taken orally, once a day for 6 months | intervention 1: Simvastatin intervention 2: Aspirin intervention 3: Placebo | 4 | Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00384865 |
[
3
] | 46 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study investigates the safety and tolerability as well as the efficacy and pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic malignancies and proven or probable invasive aspergillosis. | Due to its efficacy and a broad antifungal spectrum against relevant fungal pathogens, lack of cross-resistance to azoles and amphotericin B, documented efficacy against human Aspergillus infections, favorable pharmacokinetic properties, and excellent tolerability according to the current data, caspofungin is a highly ... | Invasive Aspergillosis | aspergillosis caspofungin maximum tolerated dose | null | 4 | arm 1: 70mg caspofungin 1x/day arm 2: 100mg caspofungin 1x/day arm 3: 150mg caspofungin 1x/day arm 4: 200mg caspofungin 1x/day | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: i.v. | intervention 1: caspofungin | 4 | Leuven | N/A | Belgium | 4.70093 | 50.87959
Berlin | N/A | Germany | 13.41053 | 52.52437
Cologne | N/A | Germany | 6.95 | 50.93333
Münster | N/A | Germany | 7.62571 | 51.96236 | 0 | NCT00404092 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | The primary objective is to determine whether the addition of bevacizumab to a regimen of carboplatin plus paclitaxel significantly improves Progression Free Survival (PFS) for patient with Stage III suboptimally cytoreduced or Stage IV ovarian, primary peritoneal or fallopian tube carcinomas. | The aim of this study is to determine if the addition of bevacizumab to a regimen of carboplatin/paclitaxel increases the time to disease recurrence (longer remission for patients) in women that have Stage III suboptimally reduced or Stage IV ovarian cancer.
The hypothesis is that the addition of bevacizumab to a carb... | Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Stage 3 Cancer Stage 4 Cancer | ovarian cancer fallopian tube cancer peritoneal cancer | null | 1 | arm 1: This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: cycle 2 (6 cycles re-evaluated and follow up) intervention 2: cycle #1 and continuous through entire regimen; treated every 3 weeks intervention 3: cycle #1 and continuous through entire regimen; treated every 3 weeks | intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Paclitaxel | 1 | Farmington | Connecticut | United States | -72.83204 | 41.71982 | 0 | NCT00408070 |
[
3
] | 78 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Objectives:
1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.
1.2 To determine the rate of measureable clinical response in patients treated with Thalidomid... | Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing.
All participants will take thalidomide capsules by mouth every evening at bedtime. Yo... | Glioblastoma Multiforme Glioma | Glioblastoma Multiforme Glioma Thalidomide Thalomid CPT-11 Irinotecan malignant glioma | null | 1 | arm 1: Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest. | [
0
] | 4 | [
0,
0,
3,
3
] | intervention 1: 100 mg PO (by mouth) daily for 8 weeks intervention 2: 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest intervention 3: Dynamic MRI scan with dye injection through vein, every 6 weeks intervention 4: QST, every 12 weeks, to check for any nerve problems that may be present... | intervention 1: Thalidomide intervention 2: CPT-11 intervention 3: MRI Scan intervention 4: Quantitative Sensory Tests (QST) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00412542 |
[
3
] | 120 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | true | The goal of this clinical research study is to compare the effectiveness of liposomal amphotericin B given three times per week , versus liposomal amphotericin B given once per week, versus oral voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome... | Ambisome and voriconazole are drugs that have been used to fight fungal infections, which typically occur during chemotherapy as a result of lowered immune system functioning. Ambisome works by binding to the sterol component of the fungal cell membrane. This causes "holes" to appear in the membrane, which leads to dea... | Acute Myelogenous Leukemia Myelodysplastic Syndrome | Voriconazole Vfend Liposomal amphotericin B Ambisome Acute Myelogenous Leukemia Myelodysplastic Syndrome AML MDS | null | 3 | arm 1: 3 mg/kg intravenously (IV) three times per week arm 2: 9 mg/kg IV once per week arm 3: 400 mg oral twice daily day 1 followed by 200 mg twice daily | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily intervention 2: 3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes intervention 3: 9 mg/kg intravenously once per week over 2 hours +/- 15 minutes | intervention 1: Voriconazole intervention 2: Liposomal amphotericin B intervention 3: Liposomal amphotericin B | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00418951 |
[
4
] | 56 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at W... | null | Hepatitis C, Chronic | null | 2 | arm 1: Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 16 weeks of treatment arm 2: Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 40 weeks of trea... | [
0,
1
] | 1 | [
0
] | intervention 1: 1. Powder for Solution in Redipen® (pegylated interferon alfa-2b) (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks
2. 200 mg ribavirin capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks | intervention 1: Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV) | 0 | null | 0 | NCT00423800 | |
[
3
] | 274 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The study investigated the magnitude of effect as well ... | null | Rheumatoid Arthritis | Active Rheumatoid Arthritis anti-interleukin-1beta monoclonal antibody methotrexate | null | 4 | arm 1: Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreas... | [
0,
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Canakinumab intervention 2: Placebo | 17 | Anniston | Alabama | United States | -85.83163 | 33.65983
Birmingham | Alabama | United States | -86.80249 | 33.52066
Peoria | Arizona | United States | -112.23738 | 33.5806
Tucson | Arizona | United States | -110.92648 | 32.22174
Palm Harbor | Florida | United States | -82.76371 | 28.07807
Palm Harbor | Florida | Unit... | 0 | NCT00424346 |
[
5
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate t... | null | Rheumatoid Arthritis | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 1g iv on days 1 and 15 intervention 2: 10-25mg po/week | intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate | 3 | Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Debrecen | N/A | Hungary | 21.62444 | 47.53167 | 0 | NCT00424502 | |
[
3
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This is an open label dose adjusted phase II trial of the oral farnesyltransferase inhibitor (FTI) lonafarnib (SCH66336) for patients with HGPS and progeroid laminopathies. | Hutchinson-Gilford Progeria Syndrome (HGPS) is a rare "premature aging" disease in which all children die at an average age of thirteen years (range 8-20 years) of severe atherosclerosis leading to strokes and heart attacks. It is a multisystem disease with objective clinical markers for disease progression. These incl... | Progeria Hutchinson-Gilford Syndrome | Hutchinson-Gilford Progeria Syndrome HGPS Progeria FTI Farnesyltransferase Inhibitor Lonafarnib | null | 1 | arm 1: All subjects initiated oral Lonafarnib twice daily at a dose of 115mg/m2 and escalated to 150 mg/m2. Two subjects de-escalated to 115mg/m2 following toxicity. | [
0
] | 1 | [
0
] | intervention 1: Lonafarnib will be taken orally, twice per day, by all patients enrolled on this study. The drug is supplied to patients in capsule form, and for patients who are unable to swallow pills, the drug may be dissolved into solution. Every patient will start lonafarnib therapy at a dose of 115mg/kg. The stud... | intervention 1: Lonafarnib | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00425607 |
[
3
] | 23 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Primary Objective:
* To determine the progression free survival (PFS) of the preparative regimen rituximab, etoposide and total body irradiation (TBI), in patients with acute lymphoblastic leukemia (ALL) receiving allogeneic hematopoietic stem cell transplantation (SCT).
Secondary Objectives:
* To determine the effe... | Disease relapse and GVHD are 2 factors that significantly impact survival in ALL patients who receive SCT. GVHD occurs when donor cells (graft) attack the stem cell recipient's (host's) cells. The term "acute" refers to the time it takes for the GVHD to appear after the transplant. This time frame is usually within the... | Leukemia | Acute Lymphoblastic Leukemia Leukemia Total Body Irradiation Etoposide Rituximab Rituxan TBI ALL | null | 2 | arm 1: Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks arm 2: Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days | [
0,
0
] | 3 | [
0,
4,
0
] | intervention 1: 60 mg/kg IV Daily Over 4 Hours for 1 Day intervention 2: 3 Gy Daily for 4 Days intervention 3: 375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks | intervention 1: Etoposide intervention 2: Total Body Irradiation intervention 3: Rituximab | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00427791 |
[
5
] | 71 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product. | null | Anemia Secondary Hyperparathyroidism | Anemia Intact Parathyroid Hormone (iPTH) Secondary Hyperparathyroidism (SHPT) | null | 1 | arm 1: Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was \> 31.8 pmol/L (300 pg/mL) unless t... | [
0
] | 1 | [
0
] | intervention 1: Cinacalcet tablets | intervention 1: Cinacalcet | 0 | null | 0 | NCT00431496 |
[
4
] | 321 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration. | null | Macular Degeneration Choroidal Neovascularization | Age-related macular degeneration; AMD choroidal neovascularization verteporfin ranibizumab | null | 3 | arm 1: Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as need... | [
0,
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 (Standard Fluence rate) or 25 J/cm\^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion. intervention 2: Ra... | intervention 1: Verteporfin Photodynamic Therapy intervention 2: Ranibizumab intervention 3: Verteporfin Placebo intervention 4: Ranibizumab Placebo | 43 | Tucson | Arizona | United States | -110.92648 | 32.22174
Beverly Hills | California | United States | -118.40036 | 34.07362
Oakland | California | United States | -122.2708 | 37.80437
Pasadena | California | United States | -118.14452 | 34.14778
Sacramento | California | United States | -121.4944 | 38.58157
San Francis... | 0 | NCT00436553 |
[
3
] | 12 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | Background:
* Vandetanib is a drug that attacks a group of proteins on the surface of many cells, especially blood vessel cells and tumor cells.
* Tumors require the development of new blood vessels in order to grow and spread.
* In laboratory experiments, vandetanib slowed the growth of certain tumors and regulated t... | Background:
* Epithelial ovarian cancer requires neovascularization for growth and metastasis. Anti-angiogenesis agents have been shown to have promise in the treatment of recurrent disease. Expression of vascular endothelial growth factor 2 (VEGFR2) and epidermal growth factor receptor (EGFR) has been demonstrated in... | Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms | Ovarian VEGFR2 EGFR Angiogenesis Tyrosine Kinase Protein Phosphorylation Vandetanib Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer | null | 1 | arm 1: 300 mg daily oral dose, 28 day cycle | [
0
] | 1 | [
0
] | intervention 1: 300 mg daily dose, 28 day cycle | intervention 1: Vandetanib | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00445549 |
[
3
] | 10 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The goal of this clinical research study is to see if RAD001 can help to control the disease in patients with systemic mastocytosis (SM). The safety of this treatment will also be studied. | RAD001 is designed to stop cancer cells from multiplying. It may also stop the growth of new blood vessels that help tumor growth, which may cause the tumor cells to die.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take p... | Systemic Mastocytosis | Systemic Mastocytosis RAD001 | null | 1 | arm 1: Oral 10 mg daily for 30 days | [
0
] | 1 | [
0
] | intervention 1: Oral RAD001 10 mg daily for 30 days | intervention 1: RAD001 (Everolimus) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00449748 |
[
3
] | 59 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in HIV-positive adults.
The hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete remi... | Human papilloma virus (HPV) can cause warts to form in the mouth of infected patients, particularly those with reduced immunity such as people infected with HIV. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges, can... | Papillomatosis HIV Infections | human immunodeficiency virus human papilloma virus warts, oral papillomatosis treatment experienced | null | 2 | arm 1: 500 IU Interferon-alpha lozenges for oral dissolution arm 2: 200 mg lozenges containing anhydrous crystalline maltose | [
0,
2
] | 2 | [
0,
10
] | intervention 1: 500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks intervention 2: 200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks | intervention 1: Interferon-alpha intervention 2: placebo | 12 | San Francisco | California | United States | -122.41942 | 37.77493
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Augusta | Georgia | United States | -81.97484 | 33.47097
Chicago | Illinois | United States | -87.65005 | 41.85003
Lexington | Kentucky | United States | -84.47772 | 37.98869
Baltimore | M... | 0 | NCT00454181 |
[
3
] | 158 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine whether ODSH, when added to conventional treatment, is more effective in treating COPD exacerbations than conventional therapy alone. | The management of acute exacerbations of COPD today is qualitatively the same as it was 40 years ago: bronchodilators, corticosteroids, and antibiotics. Because of the prominent pathophysiological role of neutrophils in exacerbations of COPD, neutrophils and their toxic oxidants and proteases represent therapeutic targ... | Chronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease COPD Heparin ODSH Exacerbations of COPD | null | 3 | arm 1: Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review. arm 2: Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours. arm 3: Sub... | [
0,
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: ODSH administered open-label intervention 2: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride intervention 3: Randomized, Blinded, ODSH Arm | intervention 1: Open-Label intervention 2: Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride intervention 3: ODSH | 38 | Orange | California | United States | -117.85311 | 33.78779
Marietta | Georgia | United States | -84.54993 | 33.9526
Shreveport | Louisiana | United States | -93.75018 | 32.52515
St Louis | Missouri | United States | -90.19789 | 38.62727
Portland | Oregon | United States | -122.67621 | 45.52345
Philadelphia | Pennsylva... | 0 | NCT00457951 |
[
3
] | 46 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG). | A phase II study was performed to assess the efficacy and tolerability of intravesical Vicinium in patients with urothelial carcinoma in situ of the bladder. Bacillus Calmette-Guérin treatment had previously failed in all patients. A total of 46 patients were treated with Vicinium with half being administered 30mg/dose... | Urinary Bladder Cancer Bladder Cancer Bladder Neoplasms Bladder Tumors | null | 2 | arm 1: Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.
If... | [
1,
1
] | 1 | [
0
] | intervention 1: Intravesical administration of Vicinium | intervention 1: Vicinium | 21 | Tallahassee | Florida | United States | -84.28073 | 30.43826
Baltimore | Maryland | United States | -76.61219 | 39.29038
Lawrenceville | New Jersey | United States | -74.7296 | 40.29733
Durham | North Carolina | United States | -78.89862 | 35.99403
Springfield | Oregon | United States | -123.02203 | 44.04624
Myrtle Bea... | 0 | NCT00462488 | |
[
3
] | 123 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of Glatiramer Acetate \[GA\].
The secondary objectives were:
* to estimate the eff... | The duration of the study period for a participant was approximatively 44 weeks broken down as follows:
* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.
'\*' Participants successfully completing the week 24 visit were offered the oppor... | Multiple Sclerosis | MS glatiramer acetate adjunctive therapy relapses | null | 3 | arm 1: Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate (GA) for 24 weeks arm 2: Teriflunomide 7 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks arm 3: Teriflunomide 14 mg once daily concomitantly with glatiramer acetate (GA) for 24 weeks | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Film-coated tablet
Oral administration intervention 2: Film-coated tablet
Oral administration intervention 3: Solution in prefilled syringe for subcutaneous injection | intervention 1: Teriflunomide intervention 2: Placebo (for teriflunomide) intervention 3: Glatiramer Acetate (GA) | 6 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Vienna | N/A | Austria | 16.37208 | 48.20849
Laval | N/A | Canada | -73.692 | 45.56995
Berlin | N/A | Germany | 13.41053 | 52.52437
Milan | N/A | Italy | 9.18951 | 45.46427
Guildford | N/A | United Kingdom | -0.57427 | 51.23536 | 0 | NCT00475865 |
[
2,
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | OncoGel™ is a new, experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel™) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel.
The purpose of this study is to evaluate the safety... | This study is for patients with recurrent glioblastoma multiforme. Because most recurrences are in the area of the original resection, local delivery of a chemotherapeutic agent may prevent or delay additional recurrences. Paclitaxel has demonstrated activity against 9L glioma tumor lines, but has poor central nervous ... | Glioblastoma Multiforme Brain Neoplasms | glioblastoma multiforme recurrent Phase 1 Phase 2 Phase I Phase II brain cancer paclitaxel intracranial tumor local chemotherapy brain tumor brain cancer glioma OncoGel | null | 1 | arm 1: OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel | [
0
] | 1 | [
0
] | intervention 1: OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection. | intervention 1: OncoGel (ReGel/Paclitaxel) | 5 | Chicago | Illinois | United States | -87.65005 | 41.85003
Baltimore | Maryland | United States | -76.61219 | 39.29038
Rochester | New York | United States | -77.61556 | 43.15478
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00479765 |
[
5
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | true | The purpose of this study is to determine whether naratriptan, a medication approved for treatment of migraine, is effective in the treatment of post traumatic headache associated with cognitive dysfunction. | Naratriptan has demonstrated efficacy in relieving headache. Other studies have demonstrated that primary headaches with at least one headache feature are likely to respond to triptans. In addition, there are anecdotal reports of triptans being effective in post traumatic headaches, especially if headache features are ... | Post Traumatic Headache | Post traumatic headache Head trauma Head injury Headache Naratriptan | null | 2 | arm 1: Naratriptan 2.5 mg tablet bid x 30 days arm 2: placebo matching naratriptan 2.5 mg tablet | [
1,
2
] | 1 | [
0
] | intervention 1: naratriptan 2.5mg tablet bid x 30 days OR matching placebo | intervention 1: naratriptan HCl | 3 | Springfield | Missouri | United States | -93.29824 | 37.21533
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00487578 |
[
5
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free... | null | Hepatitis B, Chronic | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 180 micrograms sc weekly for 48 weeks | intervention 1: peginterferon alfa-2a [Pegasys] | 23 | Chelyabinsk | N/A | Russia | 61.42915 | 55.15402
Irkutsk | N/A | Russia | 104.29585 | 52.29795
Kazan' | N/A | Russia | 49.12214 | 55.78874
Krasnoyarsk | N/A | Russia | 92.90765 | 56.02668
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
... | 0 | NCT00487747 | |
[
5
] | 59 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a Phase 3b/4, prospective, open-label, randomized, multicenter study of peginterferon alfa-2b plus ribavirin in participants with chronic hepatitis C, genotype 1. The study consists of two parts: (1) a noninterventional arm (HOMA IR \<= 2) and (2) an interventional arm (HOMA IR \> 2), where HOMA IR is the insul... | null | Hepatitis C, Chronic Insulin Resistance | homeostasis model assessment of insulin resistance | null | 2 | arm 1: HOMA IR (homeostasis model assessment-estimated insulin resistance) of \> 2
These participants received PEG-Intron 1.5 μg /kg subcutaneously (SC) once weekly plus weight based Rebetol 800-1400 mg by mouth (PO) administered twice daily (BID) for a variable period depending on their response to treatment. arm 2: ... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 1. Powder for injection in Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 12 weeks, then up to 4 weeks until HCV PCR results are available, and then for another 36 weeks(Group A) or 60 weeks (Group B) postrandomization.
2. 200 mg capsules, or... | intervention 1: Combination of pegylated interferon alfa-2b and ribavirin intervention 2: Combination of pegylated interferon alfa-2b and ribavirin | 0 | null | 0 | NCT00493805 |
[
5
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. The study was powered to to detect whether VIVITROL atte... | The double-blind phase consisted of 6 visits over a 5- to 6-week period and included 2 telephone contacts and 2 functional magnetic resonance imaging (fMRI) scans.
The optional open-label extension included 2 visits approximately 1 month apart. Subjects who completed both phases participated in a total of 8 scheduled ... | Alcohol Dependence | alcoholism addiction alcohol detoxification | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Administered via intramuscular (IM) injection once during the double-blind phase and for 2 additional injections, 4 weeks apart, during the optional open-label extension. intervention 2: Placebo matching VIVITROL 380 mg was administered by IM injection once during the double-blind phase, only. | intervention 1: VIVITROL 380 mg intervention 2: Placebo | 1 | Belmont | Massachusetts | United States | -71.17867 | 42.39593 | 0 | NCT00511836 |
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