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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 74 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo. | null | Type 2 Diabetes Mellitus | Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Metformin | null | 4 | arm 1: MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893. arm 2: MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matchin... | [
0,
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 10 mg and 100 mg tablets intervention 2: 500 mg metformin tablets intervention 3: Placebo tablets matching MK-0893 intervention 4: Placebo tablets matching metformin | intervention 1: MK-0893 intervention 2: Metformin intervention 3: Placebo intervention 4: Placebo | 0 | null | 0 | NCT02004886 |
[
4
] | 93 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6 weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with doubling the dose of simvastatin to 40 mg alone in reducing low-density lipoprotein-cholesterol (LDL-C... | null | Hypercholesterolemia Diabetes Mellitus, Type 2 Coronary Disease | null | 2 | arm 1: Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet. arm 2: Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-... | [
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 1 x 10-mg tablet, provided as blinded study treatment intervention 2: 1 x 20-mg tablet, provided as open-label study treatment intervention 3: 1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment intervention 4: 1 x 20-mg tablet, provided as blinded study treatment intervention ... | intervention 1: Ezetimibe 10 mg intervention 2: Simvastatin 20 mg intervention 3: Ezetimibe Placebo intervention 4: Simvastatin 20 mg intervention 5: Simvastatin Placebo | 0 | null | 0 | NCT00423488 | |
[
3,
4
] | 118 | RANDOMIZED | PARALLEL | null | 2DOUBLE | false | 0ALL | null | The primary objective of this study is:
* To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period.
The secondary objectives of this study are:
* To compare the safety and ocular tolerance of Nova2200... | null | Conjunctivitis, Vernal | vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin | null | 3 | arm 1: four times daily arm 2: four times daily arm 3: administered four times daily | [
0,
0,
3
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Cyclosporine NOVA22007 0.05% intervention 2: Cyclosporine NOVA22007 0.1% intervention 3: Vehicle | 1 | Paris | N/A | France | 2.3488 | 48.85341 | 0 | NCT00328653 |
[
4
] | 91 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE. | null | Hereditary Angioedema (HAE) | null | 2 | arm 1: DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections. arm 2: Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections. intervention 2: given as three 1mL subcutaneous injections. | intervention 1: ecallantide intervention 2: Phosphate Buffer Saline (PBS), | 1 | Wheaton | Maryland | United States | -77.05526 | 39.03983 | 0 | NCT00262080 | |
[
5
] | 1,000 | RANDOMIZED | PARALLEL | 0TREATMENT | null | false | 0ALL | false | The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine | null | Rhinitis, Allergic, Seasonal | once daily mountain cedar fexofenadine allergic rhinitis fluticasone furoate | null | 0 | null | null | 1 | [
0
] | intervention 1: Fluticasone furoate and fexofenadine | intervention 1: Fluticasone furoate and fexofenadine | 6 | Austin | Texas | United States | -97.74306 | 30.26715
Austin | Texas | United States | -97.74306 | 30.26715
Kerrville | Texas | United States | -99.14032 | 30.04743
New Braunfels | Texas | United States | -98.12445 | 29.703
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States |... | 0 | NCT00435461 |
[
4
] | 273 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | null | The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes. | null | Type 2 Diabetes Mellitus | null | 3 | arm 1: sitagliptin 100 mg arm 2: rosiglitazone 8 mg arm 3: placebo | [
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks. intervention 2: Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks. intervention 3: placebo - administered as one placebo tablet to match Sitagliptin 100 mg and... | intervention 1: Sitagliptin intervention 2: Comparator: Rosiglitazone intervention 3: Comparator: Placebo intervention 4: Comparator: Metformin | 0 | null | 1 | NCT00541775 | |
[
5
] | 491 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression. | Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psyc... | Depression Depressive Disorder | null | 3 | arm 1: Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) arm 2: Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine) arm 3: Could be switch... | [
0,
1,
1
] | 3 | [
5,
5,
0
] | intervention 1: brief supportive psychotherapy intervention 2: psychotherapy developed for chronic depression intervention 3: antidepressant medication | intervention 1: Brief Supportive Psychotherapy intervention 2: CBASP intervention 3: Medication Only | 8 | Tucson | Arizona | United States | -110.92648 | 32.22174
Palo Alto | California | United States | -122.14302 | 37.44188
Atlanta | Georgia | United States | -84.38798 | 33.749
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
Pittsburgh | Pennsylvania |... | 0 | NCT00057551 | |
[
3
] | 103 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate... | null | Non-Small Cell Lung Cancer | Tarceva NSCLC EGFR ECOG Performance Status 2 erlotinib Non-Small Cell Lung Cancer OSI-774 | null | 2 | arm 1: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy arm 2: Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy intervention 2: Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles | intervention 1: Tarceva (Trademark) (erlotinib HCl, OSI-774) intervention 2: Combination carboplatin and paclitaxel | 19 | Greenbrae | California | United States | -122.5247 | 37.94854
San Diego | California | United States | -117.16472 | 32.71571
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Miami | Florida | United States | -80.19366 | 25.77427
Miami Beach | Florida | United States | -80.13005 | 25.79065
Evanston | Ill... | 0 | NCT00085839 |
[
2,
3
] | 51 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this trial is: - To characterize the safety profile of motesanib when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in patients with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic (PK) profile of motesanib when it is use... | This was a multicenter, open-label, dose-finding clinical trial examining the safety and PK of once or twice daily motesanib administered with CP or with CP and panitumumab in chemotherapy naïve patients, and with panitumumab in patients with no more than one prior chemotherapy regimen for NSCLC.
Participants were enr... | Lung Cancer Non-Small Cell Lung Cancer | Lung cancer, Non-small cell lung cancer, NSCLC Clinical Trial, Panitumumab, AMG 706 Anti-angiogenesis Immunex, Abgenix, Amgen Stage IIIB, Stage IV, Unresectable | null | 3 | arm 1: Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter. The initial dose of ... | [
0,
0,
0
] | 4 | [
2,
0,
0,
0
] | intervention 1: 9.0 mg/kg on Day 1 of each 21-day cycle administered by intravenous infusion over approximately 60 minutes. intervention 2: Dose-finding with an initial dose of 50 mg once daily and up to 125 mg once daily. 75 mg twice daily was also to be tested. intervention 3: Paclitaxel 200 mg/m\^2 administered by I... | intervention 1: Panitumumab intervention 2: Motesanib diphosphate intervention 3: Paclitaxel intervention 4: Carboplatin | 0 | null | 0 | NCT00094835 |
[
3
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this trial is to determine if combination therapy with rosiglitazone and bexarotene might have a synergistic effect in the treatment of patients with CTCL. | Treatment options for CTCL include both skin-directed and systemic therapies. Topical treatments are effective for early-stage disease that is localized to the skin. However, disease involving the lymph nodes or visceral sites can be palliated but rarely cured, even with the most aggressive regimens of systemic chemoth... | Cutaneous T-cell Lymphoma Mycosis Fungoides Sezary Syndrome | Cutaneous T-cell Lymphoma CTCL Mycosis Fungoides Sezary Syndrome Bexarotene Targretin Rosiglitazone Avandia | null | 0 | null | null | 1 | [
0
] | intervention 1: rosiglitazone added to bexarotene capsules | intervention 1: Rosiglitazone and Bexarotene | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00178841 |
[
3
] | 20 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | true | Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are at greater risk for having a substance use disorder compared to people who do not have ADHD. Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults who do not have ADHD. Some clinicians sugg... | ADHD is a neurologic disorder that is thought to be caused by chemical imbalances of certain neurotransmitters in the brain. The disorder can cause inattention, hyperactivity, and impulsivity. Cocaine abuse rates in adults with ADHD are significantly higher than they are in adults who do not have the disorder. This may... | Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders | ADHD Cocaine Abuse | null | 1 | arm 1: Atomoxetine | [
0
] | 1 | [
0
] | intervention 1: At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well. | intervention 1: Atomoxetine | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00218543 |
[
3
] | 290 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the dose-response of OPC-12759 ophthalmic suspension in dry eye patients. | null | Dry Eye Syndromes | OPC-12759 Dry eye syndromes | null | 4 | arm 1: 0.5% OPC-12759 (rebamipide) ophthalmic suspension arm 2: 1% OPC-12759 (rebamipide) ophthalmic suspension arm 3: 2% OPC-12759 (rebamipide) ophthalmic suspension arm 4: placebo of OPC-12759 (rebamipide) ophthalmic suspension | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: 0.5% OPC-12759 intervention 2: 1% OPC-12759 intervention 3: 2% OPC-12759 intervention 4: placebo | 1 | Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00234078 |
[
4
] | 530 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus. | null | Type 2 Diabetes Mellitus | null | 2 | arm 1: sitagliptin 100 mg arm 2: placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks. intervention 2: placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks | intervention 1: sitagliptin phosphate intervention 2: Comparator: placebo | 0 | null | 0 | NCT00289848 | |
[
4
] | 261 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients. | null | Hypertension | null | 2 | arm 1: Losartan arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Placebo to losartan once daily for 4 weeks in run-in period. Then, losartan 50 mg for 4 weeks, then titrate to losartan 100 mg at Week 4, then titrate to losartan 100 mg + hydrochlorothiazide (HCTZ) 12.5 mg at Week 8, and finally titrate to losartan 100 mg + HCTZ 25 mg at Week 12. Duration of treatment ... | intervention 1: Comparator: losartan +/- HCTZ intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00289887 | |
[
4
] | 38 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients. | The objective of this clinical trial (STAMP: Safety and Tolerability of Alpha-1 Modified Process) is to study the safety and tolerability of Alpha-1 MP in adult Alpha 1-antitrypsin deficient subjects as reported over 20 weeks of therapy. The primary objective is to describe the nature and frequency of treatment-emergen... | Alpha 1-Antitrypsin Deficiency | alpha 1-Antitrypsin Deficiency alpha 1-Antitrypsin pulmonary emphysema | null | 1 | arm 1: Study the safety and tolerability of weekly infusions of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP, 60 mg/kg) over 20 weeks of therapy in adult Alpha-1 antitrypsin deficient subjects. | [
0
] | 1 | [
0
] | intervention 1: 60 mg/kg weekly for 20 weeks | intervention 1: alpha-1 proteinase inhibitor (human) | 10 | Denver | Colorado | United States | -104.9847 | 39.73915
Gainesville | Florida | United States | -82.32483 | 29.65163
Miami | Florida | United States | -80.19366 | 25.77427
New York | New York | United States | -74.00597 | 40.71427
Cleveland | Ohio | United States | -81.69541 | 41.4995
Philadelphia | Pennsylvania | Uni... | 0 | NCT00301366 |
[
5
] | 24 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | true | 0ALL | null | This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder. The first two weeks will be a fixe... | Specific Aims:
This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective disorder.
STUDY PROCEDURES:... | Schizophrenia | Schizophrenia Ziprasidone Diabetes Insulin Resistance | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Ziprasidone | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00351000 |
[
2,
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | Since men are less likely to develop multiple sclerosis, the hypothesis was that testosterone might be protective in MS. Men with MS for followed untreated for 6 months, followed by a 12 month treatment period with Androgel. | Background: Men are less susceptible to many autoimmune diseases including multiple sclerosis (MS). Possible causes for this include sex hormones and/or sex chromosome effects. Testosterone treatment ameliorates experimental allergic encephalomyelitis (EAE), an animal model of MS, but the effect of testosterone supplem... | Multiple Sclerosis | multiple sclerosis testosterone | null | 1 | arm 1: 6 months pretreatment, 12 months treatment intervention with Androgel 10 grams of gel containing 100mg of testosterone | [
0
] | 1 | [
0
] | intervention 1: testosterone gel | intervention 1: Androgel 10 grams of gel containing 100 mg of testosterone | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00405353 |
[
3
] | 237 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 3TRIPLE | false | 0ALL | false | The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of t... | Safety issues are addressed in the Adverse Events section | Brain Diseases Spinal Cord Diseases | Contrast Agents | null | 3 | arm 1: Participant received one dose of 0.03 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg body weight (BW) of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush ... | [
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. intervention 2: Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a po... | intervention 1: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 3: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) intervention 4: OptiMARK~0.1 mmol/kg BW | 27 | Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Jacksonville | Florida | United States | -81.65565 | 30.33218
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indi... | 0 | NCT00862459 |
[
2
] | 32 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 2MALE | false | Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design | Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design:
Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases;
Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in la... | Epilepsy | null | 2 | arm 1: Day 1 to 2: Pre-treatment 1: 600 mg ESL Day 3 to 8: Treatment 1: 1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ 100 mg PHT Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT arm 2: Day 1 to 2: Pre-treatment 2: 100 mg PHT Day 3 to 8: Treatment 2: 300 mg PHT Day 9 to 10: Treatm... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: BIA 2-093 intervention 2: Phenytoin | 0 | null | 0 | NCT02283827 | |
[
3
] | 45 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 1FEMALE | false | 45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characte... | 45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. Using CSE technique, 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic... | Anesthesia | regionel anesthesia levobupivacaine ceserean section | null | 3 | arm 1: Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Injection Surgical anaesthesia
Adult: Epidural block: 50-100 mg (10-20 ml)... | [
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: this used in intratechal area and for spinal anesthesia in ceserean section intervention 2: this used in intratechal area and for spinal anesthesia in ceserean section intervention 3: this used in intratechal area and for spinal anesthesia in ceserean section intervention 4: this used in intratechal are... | intervention 1: Levobupivacaine intervention 2: Fentanyl intervention 3: Sufentanil intervention 4: Levobupivacaine intervention 5: Levobupivacaine | 0 | null | 0 | NCT02430090 |
[
4
] | 52 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevofluran... | null | Anesthesia, General | null | 2 | arm 1: After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered. arm 2: After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a ... | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium intervention 2: Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium intervention 3: Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization. in... | intervention 1: Sugammadex intervention 2: Rocuronium intervention 3: Sevoflurane intervention 4: Propofol | 0 | null | 0 | NCT00559468 | |
[
4
] | 593 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation. | Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to... | Schizophrenia | Schizophrenia Atypical antipsychotic Psychosis | null | 3 | arm 1: Oral iloperidone arm 2: Oral ziprasidone arm 3: Oral placebo | [
0,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Iloperidone intervention 2: Ziprasidone intervention 3: Placebo | 42 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | United States | -117.9145 | 33.83529
Cerritos | California | United States | -118.06479 | 33.85835
Garden Grove | California | United States | -117.94145 | 33.77391
Glendale | California | United States | -118.25508 | 34.14251
Los Ange... | 0 | NCT00254202 |
[
4
] | 326 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder. | null | Bipolar Disorder | null | 2 | arm 1: Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID). On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1. intervention 2: Placebo fast dissolving SL tablets, BID | intervention 1: Asenapine intervention 2: Placebo | 0 | null | 1 | NCT00145470 | |
[
4
] | 149 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU). | null | Diabetes Mellitus, Type 2 | rosiglitazone Avandia type 2 diabetes mellitus diabetes | null | 1 | arm 1: study drug | [
0
] | 1 | [
0
] | intervention 1: study drug | intervention 1: Rosiglitazone (BRL49653C) | 4 | Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kumamoto | N/A | Japan | 130.69181 | 32.80589
Ōita | N/A | Japan | 131.6 | 33.23333
N/A | N/A | N/A | N/A | N/A | 0 | NCT00432679 |
[
3
] | 200 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy. | null | Anemia | null | 1 | arm 1: Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks. | [
0
] | 1 | [
0
] | intervention 1: All participants will receive epoetin beta at a dose of 30000 International Units (IU) as SC injection once every week for a total of 12 weeks. Adjustments in the dose will be implemented based on the participant's blood hemoglobin levels. | intervention 1: Epoetin Beta | 27 | Arezzo | N/A | Italy | 11.88068 | 43.46276
Ascoli Piceno | N/A | Italy | 13.57395 | 42.85351
Bussolengo VR | N/A | Italy | N/A | N/A
Busto Arsizio | N/A | Italy | 8.84914 | 45.61128
Casale Monferrato | N/A | Italy | 8.4525 | 45.13338
Catania | N/A | Italy | 15.07041 | 37.49223
Catanzaro | N/A | Italy | 16.60086 | 38.88... | 0 | NCT02761642 | |
[
3
] | 227 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA). | null | Rheumatoid Arthritis | arthritis joint pain Methotrexate | null | 3 | arm 1: Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. arm 2: Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. arm 3: Participants received placebo subcutaneous injections on Day 1 and at Month 6. | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: placebo subcutaneous injection intervention 2: For subcutaneous injection | intervention 1: placebo intervention 2: denosumab | 0 | null | 0 | NCT00095498 |
[
4
] | 166 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA). | CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalatio... | Cystic Fibrosis | Cystic Fibrosis Pseudomonas aeruginosa Pulmonary Cystic Fibrosis | null | 2 | arm 1: None arm 2: None | [
2,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: AZLI 75 mg three times a day (TID) intervention 2: Placebo three times a day (TID) | 53 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Anchorage | Alaska | United States | -149.90028 | 61.21806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | Cal... | 0 | NCT00112359 |
[
4
] | 218 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed... | null | Bipolar Disorder | null | 2 | arm 1: Asenapine 5-10 mg twice daily for 40 weeks arm 2: Olanzapine 5-20 mg once daily for 40 weeks | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Asenapine, 40 weeks intervention 2: Olanzapine, 40 weeks | intervention 1: asenapine intervention 2: Olanzapine | 0 | null | 0 | NCT00159783 | |
[
4
] | 169 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up. | Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period. | Superficial Basal Cell Carcinoma | Superficial Basal Cell Carcinoma Aldara | null | 1 | arm 1: Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks | [
0
] | 1 | [
0
] | intervention 1: Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks | intervention 1: Imiquimod 5% cream | 18 | Concord | New South Wales | Australia | 151.10381 | -33.84722
Randwick | New South Wales | Australia | 151.24895 | -33.91439
Benowa | Queensland | Australia | 153.38583 | -28.0077
Carina Heights | Queensland | Australia | 153.09126 | -27.50721
Gulliver | Queensland | Australia | 146.77691 | -19.28814
Woolloongabba | Qu... | 0 | NCT00189306 |
[
4
] | 661 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety. | This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, ... | Benign Prostatic Hyperplasia | benign prostatic hyperplasia, alpha blocker | null | 1 | arm 1: Silodosin 8 mg per day with food | [
0
] | 1 | [
0
] | intervention 1: 8 mg daily | intervention 1: Silodosin | 79 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Carmichael | California | United States | -121.32828 | 38.61713
Culver City | Califo... | 0 | NCT00224133 |
[
0
] | 13 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | An epidemiologic study of patients with asthma has shown that increased intake of soy isoflavones correlates with less severe asthma. In experimental animals, treatment with the soy isoflavone genistein reduces airways inflammation and hyper-responsiveness. In vitro studies performed by us have shows that genistein red... | This is a prospective pilot study to be conducted in 20 subjects with asthma. The participant will undergo the following procedures:
1. Completion of a questionnaire that asks for information about asthma including symptoms, medications, and ability to participate in activities.
2. Measurement of exhaled nitric oxide ... | Asthma | Asthma Soy isoflavones Eosinophils Exhaled nitric oxide | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Soy isoflavones | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00277446 |
[
3
] | 254 | NA | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months. | This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for \>=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, CF101 4 mg, or p... | Rheumatoid Arthritis | Rheumatoid Arthritis RA | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: CF101 | 35 | Peoria | Arizona | United States | -112.23738 | 33.5806
Albany | New York | United States | -73.75623 | 42.65258
Cleveland | Ohio | United States | -81.69541 | 41.4995
Perrysburg | Ohio | United States | -83.62716 | 41.557
Sugar Land | Texas | United States | -95.63495 | 29.61968
Plovdiv | N/A | Bulgaria | 24.75 | 42.1... | 0 | NCT00280917 |
[
4
] | 152 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral... | This is a randomized, double-blind, placebo controlled, multiple cross-over study. Eligible subjects will be treated with open label BEMA fentanyl over a period of up to two weeks. Doses will be titrated upward, starting at 200 μg, until a dose is identified that produces satisfactory pain relief for at least 2 episode... | Pain Cancer | Breakthrough Pain in Patients with Cancer | null | 2 | arm 1: Placebo arm 2: BioErodible MucoAdhesive (BEMA) Fentanyl | [
2,
0
] | 2 | [
0,
0
] | intervention 1: BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the... | intervention 1: BEMA™ intervention 2: Placebo | 1 | Wilmington | North Carolina | United States | -77.94604 | 34.23556 | 0 | NCT00293033 |
[
5
] | 88 | RANDOMIZED | FACTORIAL | 0TREATMENT | 1SINGLE | true | 0ALL | true | The purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. One strategy, resistance training, is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ agonist, is designed to enhance the loss of fat f... | In this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at risk for disability and with indications for weight loss according to NIH guidelines. All will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period. All will receive sup... | Obesity Overweight With Indications for Weight Loss | Body Composition Sarcopenia Weight loss trials Intervention studies Elderly | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
1,
1,
1
] | 4 | [
0,
5,
5,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Pioglitazone intervention 2: Resistance exercise training to maximize muscle power intervention 3: Hypocaloric diet intervention 4: Placebo | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00315146 |
[
3
] | 12 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | true | The investigators hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of sulfonylurea (SU) we hope to restore the insulinotropic effect of GIP. | null | Diabetes Mellitus, Type 2 | Type 2 diabetes mellitus Glucose dependent insulinotropic polypeptide Sulfonylurea compounds insulin secretion Sulfonylurea receptor subunit-SUR1 Impaired incretin effect | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: Sulfonylurea | 1 | Hellerup, Copenhagen | N/A | Denmark | N/A | N/A | 0 | NCT00321321 |
[
0
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.
Primary outcomes: Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients. | * Single-center, open label study of pioglitazone in clinically stable patients with mild to moderate CF lung disease
* Induced sputum will be obtained from each subject at enrollment (Baseline) and again following 28 days of pioglitazone treatment (End of Treatment)
* Changes in markers of inflammation in the sputum s... | Cystic Fibrosis | Prescription drugs Administration, oral Durable medical equipment Kinetics | null | 1 | arm 1: All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda | [
0
] | 1 | [
0
] | intervention 1: All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily. | intervention 1: pioglitazone | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00322868 |
[
3
] | 311 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or pla... | null | Asthma Common Cold Picornavirus Infection Rhinovirus | null | 2 | arm 1: Participants will receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses. arm 2: Participants will receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril. intervention 2: Placebo nasal suspension | intervention 1: Pleconaril intervention 2: Placebo to Pleconaril | 0 | null | 0 | NCT00394914 | |
[
4
] | 147 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 1SINGLE | false | 0ALL | false | The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin. | The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial. | Central Nervous System Diseases | Gadovist Gadavist Contrast agent Brain Spine disease Magnetic Resonance Imaging | null | 2 | arm 1: Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec) arm 2: Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1,0M, intra venous injection at a dose of 0,1 ml/kg BW (= 0,1 mmol Gd/kg BW) intervention 2: 0,5M, intra venous injection at a dose of 0,2 ml/kg BW (= 0,1 mmol Gd/kg BW) | intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Magnevist | 4 | Nanjing | Jiangsu | China | 118.77778 | 32.06167
Xi'an | Shaanxi | China | 108.92861 | 34.25833
Beijing | N/A | China | 116.39723 | 39.9075
Shanghai | N/A | China | 121.45806 | 31.22222 | 0 | NCT00395460 |
[
4
] | 36 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis Pharma (formerly Axcan). | This is a Phase III, multicenter, randomized, double-blind, two-period cross-over, placebo-controlled study designed to compare the efficacy and safety of Ultrase® MT20 to placebo in participants with CF and pancreatic insufficiency. The study consists of a screening period (up to 11 days) and two treatment periods (6-... | Cystic Fibrosis Exocrine Pancreatic Insufficiency | Cystic Fibrosis Exocrine Pancreatic Insufficiency Ultrase® MT20 | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period. intervention 2: Placebo matched to Ultrase®... | intervention 1: Ultrase® MT20 intervention 2: Placebo | 4 | Grand Rapids | Michigan | United States | -85.66809 | 42.96336
Cleveland | Ohio | United States | -81.69541 | 41.4995
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00408317 |
[
5
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if rosiglitazone treatment improves integrated cardiovascular performance in patients at risk for congestive heart failure. A second aim of this study is to determine if treatment with rosiglitazone decreases intracellular (ectopic) triglyceride (TG) deposition in cardiomyocyte... | Cardiovascular disease (CVD), including congestive heart failure (CHF), accounts for over 75% of deaths among patients with diabetes. Thus, it is imperative to rigorously evaluate existing and emerging hypoglycemic therapies with regard to their cardiovascular consequences. The thiazolidinedione (TZD) class of drugs, a... | Diabetes Mellitus, Type 2 | Diabetes Mellitus, Type 2 Congestive Heart Failure Cardiopulmonary exercise testing intracellular cardiomyocyte triglycerides thiazolidinedione rosiglitazone nuclear magnetic resonance | null | 2 | arm 1: 4mg titrated to 8mg daily arm 2: blinded matching placebo treatment | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 6 months of treatment of blinded study drug intervention 2: blinded treatment with matching placebo | intervention 1: rosiglitazone intervention 2: placebo | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00424762 |
[
5
] | 26 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline t... | null | Asthma | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks intervention 2: Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks | intervention 1: Asmanex twisthaler intervention 2: Placebo for Asmanex twisthaler | 0 | null | 0 | NCT00442351 | |
[
5
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The study aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients. The study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms, as well as assess tolerability and ... | This is a ten-week, parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 2, 3. 4, 5, 6, 7, 8 \& 10 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia.
Specific aims:
1. Assess the effects of a single do... | Schizophrenia | schizophrenia cognition d-cycloserine memory | null | 2 | arm 1: 50 mg d-cycloserine arm 2: 50 mg placebo | [
0,
2
] | 1 | [
0
] | intervention 1: 50mg dose d-cycloserine v placebo | intervention 1: d-cycloserine | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00455702 |
[
2,
3
] | 21 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis. | The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC \< 2x10\^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (\<= 1.0 mf/kf/day, a maximum dose of 8... | Lupus Nephritis | Lupus nephritis Deoxyspergualin Immunosuppression | null | 1 | arm 1: NKT-01 | [
0
] | 1 | [
0
] | intervention 1: SC, 0.5 mg/kg/day, consecutive 14 days administrations, 1 week rest, 9 cycles. | intervention 1: NKT-01 | 6 | Prague | N/A | Czechia | 14.42076 | 50.08804
Berlin | N/A | Germany | 13.41053 | 52.52437
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Heidelberg | N/A | Germany | 8.69079 | 49.40768
Mannheim | N/A | Germany | 8.46694 | 49.4891
Regensburg | N/A | Germany | 12.10161 | 49.01513 | 0 | NCT00709722 |
[
4
] | 210 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 0ALL | false | The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo. | To determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo. | Diarrhea | TD traveller's diarrhea campylobacter shigella salmonella E. coli diarrhea | null | 2 | arm 1: Rifaximin arm 2: Placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Rifaximin intervention 2: Placebo | 1 | Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738 | 0 | NCT00742469 |
[
2
] | 26 | RANDOMIZED | CROSSOVER | 5SCREENING | 0NONE | true | 0ALL | null | * Objective:
* Compare the bioequivalence of a test topiramate formulation (Torrent Pharmaceuticals Limited) to an equivalent oral dose of the commercially available topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) in a test population of 26 adult subjects under fasted conditions.
* Clinical Design:
* Studie... | null | Healthy | null | 2 | arm 1: tablet containing 25 mg of topiramate (Torrent Pharmaceuticals) arm 2: tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.) | [
0,
1
] | 1 | [
0
] | intervention 1: Topiramate (brand name Topamax) is an anticonvulsant (antiepilepsy) drug. IUPAC name 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate | intervention 1: Topiramate | 1 | Saint Charles | Missouri | United States | -90.48123 | 38.78394 | 0 | NCT00939692 | |
[
3
] | 47 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single do... | null | Acute Low Back Pain | Back Pain | null | 1 | arm 1: 1 Tramadol Contramid® OAD 200mg tablet daily. | [
0
] | 1 | [
0
] | intervention 1: 1 Tramadol Contramid® OAD 200mg tablet daily. | intervention 1: Tramadol Contramid® OAD 200mg | 0 | null | 0 | NCT00952068 |
[
2
] | 36 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 1FEMALE | false | The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the reference Activella® (1 mg estradiol/0.5 mg norethindrone acetate) Tablets under fasting condi... | Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods | Healthy | Healthy Bioequivalence Post-Menopausal | null | 2 | arm 1: Estradiol/Norethindrone acetate 1/0.5 mg Tablets arm 2: Activella® 1/0.5 mg Tablets | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1/0.5 mg Tablets intervention 2: 1/0.5 mg Tablets | intervention 1: Estradiol/Norethindrone acetate intervention 2: Activella® | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT01157182 |
[
4
] | 83 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks. | Randomized subjects treated for a qualifying attack were eligible to receive rescue dosing with 1,000 U of C1INH-nf if they did not achieve beginning of substantial relief of the defining symptom within 4 hours after initial treatment with blinded study drug, or if at any time the attack progressed to include airway co... | Hereditary Angioedema | Hereditary angioedema HAE C1 esterase inhibitor (human) C1INH-nf | null | 2 | arm 1: 1,000 Units (U) of C1INH-nf administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered. arm 2: Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placeb... | [
0,
2
] | 2 | [
2,
0
] | intervention 1: None intervention 2: None | intervention 1: C1 esterase inhibitor [human] (C1INH-nf) intervention 2: Placebo (saline) | 37 | Hoover | Alabama | United States | -86.81138 | 33.40539
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
Walnut Creek | California | United States | -122.06496 | 37.90631
Fort Laud... | 0 | NCT00289211 |
[
3
] | 1,415 | RANDOMIZED | PARALLEL | 0TREATMENT | null | false | 0ALL | false | The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion. | null | Sepsis | severe sepsis septic shock Gram-negative infection phospholipid emulsion | null | 0 | null | null | 2 | [
0,
10
] | intervention 1: None intervention 2: None | intervention 1: Intravenous GR270773- Phospholipid Emulsion intervention 2: Placebo | 390 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Bentonville | Arkansas | United States | -94.20882 | 36.37285
Little Rock | Arkansas | U... | 0 | NCT00089986 |
[
5
] | 116 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with schizophrenia or schizoaffective disorder. | Little research has been conducted on the use of psychotropic agents in children and adolescents with early onset schizophrenia spectrum disorders. This study will compare antipsychotic agents with different mechanisms of action in children and adolescents who have schizophrenia or schizoaffective disorder with active ... | Schizophrenia | Psychotic Disorders Schizophreniform Disorder | null | 3 | arm 1: oral olanzapine 5-20mg per day for up to 52 weeks arm 2: oral risperidone 0.5mg to 6mg daily for up to 52 weeks arm 3: oral molindone from 10-140mg/daily for up to 52 weeks | [
1,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: oral risperidone 0.5mg to 6mg daily for up to 52 weeks intervention 2: oral olanzapine 5-20mg per day for up to 52 weeks intervention 3: oral molindone from 10-140mg/daily for up to 52 weeks | intervention 1: Risperidone intervention 2: Olanzapine (enrollment closed in this treatment) intervention 3: Molindone | 4 | Medford | Massachusetts | United States | -71.10616 | 42.41843
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Cleveland | Ohio | United States | -81.69541 | 41.4995
Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00053703 |
[
4
] | 1,172 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes). | The duration of treatment is 104 weeks. | Diabetes Mellitus, Type 2 | null | 2 | arm 1: Sitagliptin 100 mg oral tablets of sitagliptin once daily. arm 2: Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Sitagliptin 100 mg oral tablets of sitagliptin once daily. intervention 2: Glipizide 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control. | intervention 1: sitagliptin (MK0431) intervention 2: Comparator: glipizide | 0 | null | 0 | NCT00094770 | |
[
4
] | 312 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safet... | null | Major Depressive Disorder | Major Depressive Disorder Depression Adolescents Escitalopram Pediatrics | null | 2 | arm 1: Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks arm 2: Placebo once daily for up to 8 weeks | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks intervention 2: Placebo once daily for up to 8 weeks | intervention 1: Escitalopram intervention 2: Placebo | 28 | Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Gainesville | Florida | United States | -82.32483 | 2... | 0 | NCT00107120 |
[
5
] | 551 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacen... | This was a Phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions, conducted at 31 investigational sites in the United States.
This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 1... | Keratosis | actinic keratosis lesions large head torso extremities actinic keratosis | null | 1 | arm 1: Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets. | [
0
] | 1 | [
0
] | intervention 1: imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles | intervention 1: imiquimod cream | 32 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Encino | California | United States | -118.50119 | 34.15917
Los Angeles | California | United States | -118.24368 | 34.05223
Riverside | California | United States | -117.39616 | 33.95335
San Diego | California | United States | -117.16472 | 32.71571
Santa Monic... | 0 | NCT00116649 |
[
4
] | 771 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia. | null | Bacterial Pneumonia | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Telavancin 10 mg/kg/day IV for up to 21 days intervention 2: Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days | intervention 1: Telavancin intervention 2: Vancomycin | 1 | Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096 | 0 | NCT00124020 | |
[
3
] | 142 | NA | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | false | The purpose of this project is to assess the change in dopamine transporter density in Parkinson's disease subjects during a sixty month period including a nine month treatment trial of levodopa. Dopamine transporter will be assessed using \[123I\]ß-CIT SPECT (single photon emission computed tomography) imaging, a mark... | All subjects will be imaged at the Institute for Neurodegenerative Disorders.
Subjects will be evaluated sequentially with \[123I\]ß-CIT SPECT and standardized clinical rating scales during a sixty month period. The subjects involved in this study will have had \[123I\]ß-CIT and SPECT scans at baseline and return for ... | Parkinson Disease | parkinson brain imaging | null | 1 | arm 1: To assess\[123I\]B-CIT SPECT imaging in early Parkinson's disease subjects on placebo compared to early verses later Levodopa. Subjects on Levodopa 150mg/day, Levodopa 300 mg/day, and Levodopa 600 mg/day will be assessed. | [
0
] | 1 | [
0
] | intervention 1: To assess \[123I\]B-CIT SPECT imaging | intervention 1: [123I]B-CIT SPECT imaging | 0 | null | 0 | NCT00134784 |
[
3
] | 81 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Cocaine is one of the most widely abused drugs in the United States. Memantine is a type of drug called an NMDA receptor antagonist. It works by decreasing normal excitement in the brain. NMDA receptor antagonists have shown to reduce cocaine-induced dopamine release in animal models, as well as lessen conditioned coca... | Memantine is a non-competitive NMDA receptor antagonist that works by decreasing normal excitement in the brain. Dopamine plays a role in the rewarding and addictive properties of cocaine, however, past clinical studies have not been successful in using dopamine agonists in treating cocaine dependent individuals. Non-c... | Cocaine-Related Disorders | Cocaine dependence treatment memantine | null | 2 | arm 1: Memantine arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Memantine intervention 2: placebo | intervention 1: Memantine intervention 2: placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00134901 |
[
5
] | 548 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 0ALL | true | Compared to standard treatment goals achieving lower targets for LDL cholesterol (bad cholesterol) and blood pressure in people with diabetes will slow the progression of atherosclerosis as measured by carotid artery thickness, and reduce clinical cardiovascular events such as heart attacks and strokes. This study is a... | Diabetes incidence is increasing rapidly in the United States. Diabetes increases the risk for CVD, the major cause of death in diabetic individuals. The conventional cardiovascular risk factors of hyperlipidemia and hypertension add to the progression of diabetic vascular disease. Appropriate treatment targets for LDL... | Cardiovascular Disease Hypertension Hyperlipidemia Diabetes Carotid Atherosclerosis | lowering LDL and BP below current targets LDL cholesterol treatment blood pressure treatment carotid intimal medial thickness prevent progression of CVD | null | 2 | arm 1: Standard Treatment for blood pressure and cholesterol arm 2: FDA approved drugs to treat blood pressure and cholesterol | [
4,
1
] | 1 | [
0
] | intervention 1: None | intervention 1: FDA approved drugs to treat blood pressure and cholesterol | 4 | Chinle | Arizona | United States | -109.55261 | 36.15445
Phoenix | Arizona | United States | -112.07404 | 33.44838
Lawton | Oklahoma | United States | -98.39033 | 34.60869
Rapid City | South Dakota | United States | -103.23101 | 44.08054 | 0 | NCT00147251 |
[
0
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of the study is to examine the effectiveness of mifepristone treatment in patients with refractory depression. Refractory depression is defined as clinical depression that is unimproved after treatment with at least 2 different antidepressants of adequate dose and time trial. Mifepristone will augment curre... | Study Procedures:
This study will be a double-blind placebo-controlled 5-week trial.
Thirty patients with treatment refractory major depression will be studied over a one year period. Patients will be screened for eligibility, no more than two weeks prior to enrollment, which will involve psychiatric interviews (incl... | Depression | null | 2 | arm 1: Patients received mifepristone for 6 days arm 2: Patients received placebo for 6 days | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Glucocorticoid antagonist intervention 2: Inactive placebo tab | intervention 1: Mifepristone intervention 2: Placebo Oral Tablet | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00186056 | |
[
2,
3
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The aims of this protocol are:
1. To study the safety and tolerability of the combination of etanercept and gemcitabine in patients with advanced pancreatic cancer:
2. To estimate the anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation. | Rationale: The standard treatment for pancreatic cancer is gemcitabine. This study combines gemcitabine with etanercept, a drug that binds with tumor necrosis factor (TNF) molecules and blocks their activity through inhibiting their interaction with cell surface TNF receptors. TNF is the name for a protein in the body ... | Pancreatic Neoplasms Adenocarcinoma | Advanced Stage Chemotherapy Naive | null | 2 | arm 1: Patients received entanercept 25 mg subcutaneously twice weekly with gemcitabine. arm 2: Patients with pancreatic cancer for which treatment with gemcitabine as a single agent is planned will be asked to participate in this trial as a control group. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment. intervention 2: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days ... | intervention 1: Gemcitabine intervention 2: Etanercept | 1 | Columbus | Ohio | United States | -82.99879 | 39.96118 | 0 | NCT00201838 |
[
4
] | 390 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine the efficacy and safety of alogliptin, once daily (QD), taken in combination with insulin for the treatment of Type 2 Diabetes. | There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, ... | Diabetes Mellitus | Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks. | intervention 1: Alogliptin and insulin intervention 2: Alogliptin and insulin intervention 3: Insulin | 60 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Artesia | California | United States | -118.08312 | 33.86585
Fresno | California | United States | -119.77237 | 36.74773
Mission Viejo | California | United States | -117.672 | 33.60002
Northridge | Cal... | 0 | NCT00286429 |
[
2
] | 9 | NON_RANDOMIZED | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | false | This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary study objective was to determine the biodistribution and pharmacokinetics (PK) of 111-In-CMD-193 (i.e., CMD-193 tagged with... | Subjects received a single infusion of 111-In-CMD-193 on Day 1. Collection of blood for PK and whole body gamma camera imaging for assessment of biodistribution and tumor uptake were performed on Days 1, 2, 3 or 4, 5 or 6, and 7 or 8 following the 111-In-CMD-193 infusion. Subjects were evaluated for safety for 3 hours ... | Neoplasms | null | 2 | arm 1: Subjects received 111-In-CMD-193 on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 1.0 mg/m\^2 on Day 1 of subsequent 21-day cycles. arm 2: Subjects received 111-In-CMD-193 on Day 1 of Cycle 1. Subjects received CMD-193 at a dose of 2.6 mg/m\^2 on Day 1 of subsequent 21-day cycles. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 111-In-CMD-193 (3-7 mCi) was administered as an IV infusion over 60 (± 5) minutes. intervention 2: CMD-193 was administered as an IV infusion over 60 (± 5) minutes. | intervention 1: 111-Indium-CMD-193 intervention 2: CMD-193 | 2 | Herston | Queensland | Australia | 153.01852 | -27.44453
Heidelberg (Melbourne) | Victoria | Australia | 145.06667 | -37.75 | 0 | NCT00293215 | |
[
3
] | 1,737 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 0ALL | null | The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite P. fal... | null | Malaria | null | 8 | arm 1: Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part o... | [
0,
0,
0,
0,
1,
1,
1,
1
] | 6 | [
2,
2,
2,
2,
0,
0
] | intervention 1: IM injection in the deltoid muscle intervention 2: IM injection in the deltoid muscle intervention 3: IM injection in the deltoid muscle intervention 4: IM injection in the deltoid muscle intervention 5: 1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance intervention 6: 1 dose oral... | intervention 1: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 intervention 2: Engerix™-B intervention 3: Hiberix® intervention 4: Prevnar™ intervention 5: sulfadoxine-pyrimethamine intervention 6: amodiaquine | 1 | Maputo | N/A | Mozambique | 32.58322 | -25.96553 | 0 | NCT00323622 | |
[
5
] | 142 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to th... | null | HIV Infections | null | 1 | arm 1: Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following th... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: As prescribed intervention 2: As prescribed intervention 3: 90mg sc bid | intervention 1: Background ARVs intervention 2: PI intervention 3: enfuvirtide [Fuzeon] | 38 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Bakersfield | California | United States | -119.01871 | 35.37329
Beverly Hills | California | United States | -118.40036 | 34.07362
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
... | 0 | NCT00326963 | |
[
3
] | 71 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 \[NCT00245765\] and Week 12 of re-treatment in this study. | null | Psoriasis | Moderate to severe chronic plaque psoriasis anti TNF α CDP 870 Cimzia® certolizumab pegol retreatment | null | 2 | arm 1: Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter. arm 2: Subcutaneous injections of 400 mg every 2 weeks. | [
0,
0
] | 1 | [
0
] | intervention 1: * Pharmaceutical Form: Solution for injection in pre-filled syringe
* Route of Administration: Subcutaneous use
* Dose and Administration details :
2 x 1 mL Certolizumab Pegol at Week 0, followed by
* 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 2... | intervention 1: Certolizumab Pegol (Cimzia®) | 14 | Besançon | N/A | France | 6.01815 | 47.24878
Créteil | N/A | France | 2.46569 | 48.79266
Nice | N/A | France | 7.26608 | 43.70313
Paris | N/A | France | 2.3488 | 48.85341
Pierre-Bénite | N/A | France | 4.82424 | 45.70359
Berlin | N/A | Germany | 13.41053 | 52.52437
Bonn | N/A | Germany | 7.09549 | 50.73438
Essen | N/A ... | 0 | NCT00329303 |
[
4
] | 522 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to compare the efficacy and safety of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP). | Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly l... | Pneumonia | Pneumonia Respiratory Infection Infectious Advanced Life Sciences Lung Pulmonary Cethromycin Clarithromycin Biaxin | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Cethromycin 300 mg once per day (QD) for 7 days, administered orally intervention 2: Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally | intervention 1: Cethromycin intervention 2: Clarithromycin | 13 | Woodridge | Illinois | United States | -88.05034 | 41.74697
Woodridge | Illinois | United States | -88.05034 | 41.74697
Woodridge | Illinois | United States | -88.05034 | 41.74697
Woodridge | Illinois | United States | -88.05034 | 41.74697
Woodridge | Illinois | United States | -88.05034 | 41.74697
Woodridge | Illinois... | 0 | NCT00336544 |
[
4
] | 789 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks. | null | Overactive Bladder | OAB, anticholineric, oxybutynin, urge urinary incontinence | null | 2 | arm 1: Oxybutynin topical gel arm 2: placebo topical gel | [
0,
2
] | 2 | [
0,
10
] | intervention 1: 1 application daily to skin for 12 weeks intervention 2: 1 application daily to skin for 12 weeks | intervention 1: Oxybutynin topical gel intervention 2: Placebo topical gel | 63 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Homewood | Alabama | United States | -86.80082 | 33.47177
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United States | -86.29997 | 32.36681
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United St... | 0 | NCT00350636 |
[
4
] | 158 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy. | null | Epilepsy | Epilepsy Keppra® XR Levetiracetam XR Extended release | null | 2 | arm 1: Keppra® extended release formulation -XR arm 2: placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 500mg extended release oral tablet, 2 tablets once daily intervention 2: oral tablets, 2 tablets once daily | intervention 1: Keppra® extended release formulation - XR intervention 2: Placebo | 34 | Curitiba | N/A | Brazil | -49.27306 | -25.42778
Kuopio | N/A | Finland | 27.67703 | 62.89238
Tampere | N/A | Finland | 23.78712 | 61.49911
Turku | N/A | Finland | 22.26869 | 60.45148
Chennai | N/A | India | 80.27847 | 13.08784
Chennai | N/A | India | 80.27847 | 13.08784
Gandhinagar | N/A | India | 72.68333 | 23.21667
H... | 0 | NCT00368069 |
[
3
] | 9 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number ... | This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if 240 µg/kg plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minim... | Multiple Myeloma | Multiple Myeloma Stem cell mobilization apheresis | null | 1 | arm 1: Participants with MM who were eligible for autologous peripheral blood stem cell transplantation. | [
0
] | 1 | [
0
] | intervention 1: Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4\*10\^6 CD34+ cells/kg body weight had been collected. | intervention 1: plerixafor | 2 | New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00396383 |
[
0
] | 12 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The main purpose of this study is to examine the effect of tipranavir combined with ritonavir, medications for the treatment of HIV-infection, on buprenorphine/naloxone (BUP) in people who have been receiving the same dose of buprenorphine/naloxone for at least 3 weeks before study entry. | A large number of people with HIV-infection obtained HIV through injection drug use. Some of these people are currently being treated with buprenorphine/naloxone (BUP) for their addiction and with medications for HIV infection. Tipranavir is a medication that was recently approved by the Food and Drug Administration (F... | HIV Infections | HIV Pharmacokinetics Buprenorphine Tipranavir HIV Seronegativity | null | 1 | arm 1: None | [
5
] | 1 | [
0
] | intervention 1: After determining buprenorphine/naloxone pharmacokinetics over a 24-hour period, tipranavir/ritonavir and buprenorphine/naloxone will be coadministered for 7 days. | intervention 1: Buprenorphine, Tipranavir and ritonavir | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00486330 |
[
4
] | 285 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | false | Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study. | null | Other Osteoporosis | null | 2 | arm 1: Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years arm 2: 35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years | [
2,
0
] | 2 | [
0,
0
] | intervention 1: one placebo once a week for two years followed by one 35 mg risedronate once a week for two years intervention 2: one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years | intervention 1: Placebo tablet intervention 2: Risedronate | 23 | Palm Desert | California | United States | -116.37697 | 33.72255
Lakewood | Colorado | United States | -105.08137 | 39.70471
Stuart | Florida | United States | -80.25283 | 27.19755
St Louis | Missouri | United States | -90.19789 | 38.62727
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Portland | Oregon | Uni... | 0 | NCT00619957 | |
[
4
] | 327 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX. | null | Rheumatoid Arthritis | Rheumatoid Arthritis RA Infliximab TA-650 Remicade | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46. intervention 2: 3 mg/kg of TA-650 will be intravenously infused over a period of... | intervention 1: TA-650 3 mg/kg intervention 2: TA-650 6 mg/kg intervention 3: TA-650 10 mg/kg | 0 | null | 0 | NCT00691028 |
[
3
] | 176 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Eligible subjects will be randomly assigned to one of three dose regimens of oral R115866 or placebo for the treatment of severe plaque psoriasis for 12 twelve weeks. The safety and efficacy of R115866 will be evaluated during the treatment period and the 8-week post treatment follow-up period. | null | Psoriasis | Psoriasis | null | 4 | arm 1: Talarozole 0.5 mg arm 2: Talarozole 1.0 mg arm 3: Talarozole 2.0 mg arm 4: Talarozole matching Placebo | [
1,
1,
1,
2
] | 1 | [
0
] | intervention 1: Oral Capsule Once Daily | intervention 1: Talarozole | 22 | Augsburg | N/A | Germany | 10.89851 | 48.37154
Berlin | N/A | Germany | 13.41053 | 52.52437
Dresden | N/A | Germany | 13.73832 | 51.05089
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Hamburg | N/A | Germany | 9.99302 | 53.55073
Salzwedel | N/A | Germany | 11.1525 | 52.85435
Cork | N/A | Ireland | -8.47061 | 51.89797... | 0 | NCT00716144 |
[
4
] | 221 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | To evaluate superiority of HDC in comparison to placebo in the treatment of chronic low-back pain in relation to pain, functional impairment, quality of life, and state of health during a 15-week treatment period. | Low-back pain is often provoked by inflammatory edema in the region of the facet joints. In naturopathy, a fixed homeopathic drug combination (HDC) is established in the treatment of edema and swellings. For the first time, the efficacy of HDC was investigated in the treatment of low-back pain.
Objective: To examine t... | Low Back Pain | low-back pain chronic constitution diathesism homoeopathy fixed combination herbal preparation chronic low back pain lasting more than 6 months | null | 2 | arm 1: HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks. arm... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X),10 drops t.i.d. for 15 weeks. inte... | intervention 1: HDC intervention 2: Placebo solution | 1 | Hattingen | N/A | Germany | 7.18557 | 51.39894 | 0 | NCT01049373 |
[
3
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the possible efficacy of low dose, orally administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF). | This is a pilot study to determine if oral administration of low doses of Interferon alpha might be effective in treating Idiopathic Pulmonary Fibrosis (IPF). This is a disease that damages the lungs leading to marked decreases in the quality of life and death within 3-5 years after diagnosis. The cause is unknown. The... | Respiratory Tract Diseases Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis Interferon alpha | null | 0 | null | null | 1 | [
0
] | intervention 1: dose form - oral lozenge dose - 150 International Units (IU) frequency - 3 times a day duration - at least 1 year | intervention 1: Interferon alpha oral lozenge | 1 | Lubbock | Texas | United States | -101.85517 | 33.57786 | 0 | NCT01442779 |
[
2
] | 50 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 0ALL | false | Subjects to compare the single dose bioavailability of Torrent's Zolpidem Tartrate Tablets 10mg and Ambien® Tablets 10 mg of Sanofi-Synthelabo Inc. | An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Zolpidem Tartrate Tablets containing Zolpidem Tartrate 10 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Ambien® Tablets 10 mg containing Zolpidem Tartrate 10 mg (Reference , Sanofi-Synthelab... | Healthy | null | 2 | arm 1: Torrent's Zolpidem TartrateTablets 10 mg arm 2: Sanofi-Synthelabo Inc's Ambient® Tablets 10 mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Zolpidem Tartrate Tablets 10 mg intervention 2: 'Sanofi-Synthelabo Inc's Ambien® Tablets 10 mg | 1 | Mumbai | Maharashtra | India | 72.88261 | 19.07283 | 0 | NCT00939367 | |
[
2
] | 15 | NON_RANDOMIZED | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | false | The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NC... | This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned.
Patients, with advanced or metastatic solid tumor previously treated with a non cumulative dose of doxorubicin (\<300 mg/sqm in order to allow an a... | Cancer | NGR-hTNF doxorubicin solid tumors | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: 0.2, 0.4, 0.8 and 1.6 μg/m²as 60-minute intravenous infusion every 3 weeks intervention 2: 75 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion) | intervention 1: NGR-hTNF intervention 2: Doxorubicin | 4 | Rozzano | Milan | Italy | 9.1559 | 45.38193
Genova | N/A | Italy | 11.87211 | 45.21604
Milan | N/A | Italy | 9.18951 | 45.46427
Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 | 0 | NCT00305084 |
[
3
] | 68 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects ... | A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 administered once daily in the morning via DISKUS™ dry-powder inhaler) compared with SEREVENT (salmeterol) (50mcg administered twi... | Pulmonary Disease, Chronic Obstructive | Chronic Obstructive Pulmonary Disease (COPD) COPD | null | 4 | arm 1: Twice daily in the morning. arm 2: Twice daily in the morning. arm 3: Twice daily. arm 4: Twice daily | [
1,
1,
1,
2
] | 2 | [
0,
10
] | intervention 1: GW642444H intervention 2: Placebo administered twice daily | intervention 1: GW642444 intervention 2: Placebo | 14 | Camperdown | New South Wales | Australia | 151.17642 | -33.88965
Nedlands | Western Australia | Australia | 115.8073 | -31.98184
Rousse | N/A | Bulgaria | 25.9534 | 43.84872
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Weinheim | Baden-Wurttemberg | Germany | 8.66697 | 49.54... | 0 | NCT00372112 |
[
3
] | 33 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | Objectives:
The primary objective of this trial was to evaluate the patients response rate at the end of the study.
Patients were considered responder if one of the following conditions occurs:
* Disease remission (Powell Tuck ≤ 3 or CDAI \< 150) and withdrawal of oral steroids therapy from at least the second treat... | This was a single-center, placebo-controlled, randomised, phase II explorative study with the aim to investigate the ability of the new steroid delivery system to induce or maintain remission in steroid-dependent or mesalazine refractory patients suffering from Chron's disease (CD) or Ulcerative Colitis (UC) .
Once th... | Ulcerative Colitis | Ulcerative colitis Steroid-dependency Steroid adverse events Erythrocytes | null | 2 | arm 1: In this arm a dose of 20 ml of Dex 2-P solution was administered every 15 or 30 days for a total of 3 or 6 treatment procedures, respectively.
Specifically, steroid-dependant IBD patients had to undergo a total of 6 procedures at one month interval, while active mesalazine refractory UC patients had to undergo ... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: At each procedure 50 ml of patient whole blood was washed with saline solution and centrifugated. The isolated erythrocytes were suspended into 2 hypotonic solutions to make their membrane permeable and incubated with Dex 21-P sodium salt up to obtain a final concentration of 10 mM. The drug loaded eryt... | intervention 1: Dex 21-P intervention 2: Placebo | 1 | San Giovanni Rotondo | N/A | Italy | 15.7277 | 41.70643 | 0 | NCT01171807 |
[
3
] | 32 | RANDOMIZED | CROSSOVER | 0TREATMENT | null | false | 0ALL | false | This current study is planned as a dedicated pharmacodynamic (effect of drug on the body) study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been proven to work (200mcg) or expected to (50mcg) work. This study also aims to investigate the lower end of the predicted therapeutic rang... | null | Rhinitis, Allergic, Seasonal | Seasonal allergic rhinitis, hayfever | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: GSK256066 | 1 | Berlin | N/A | Germany | 13.41053 | 52.52437 | 0 | NCT00464568 |
[
2
] | 24 | RANDOMIZED | CROSSOVER | 4SUPPORTIVE_CARE | 0NONE | true | 0ALL | false | Determine and compare the plasma concentrations and safety and tolerability of Guaifenesin and hydrocodone bitartrate when they are administered alone or in combination to normal healthy male and/or female subjects. | null | Healthy Subjects | null | 3 | arm 1: Guaifenesin (Humibid®) single extended release 1200 mg tablet administered with 240 mL of room temperature water under fasted conditions. arm 2: Hydrocodone Bitartrate of 10 mg in 3 oral doses of a single 3.33 mg tablet in three intervals administered with 240 mL of room temperature water in the fasted state. ar... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Humibid® 1200 mg (single extended release) tablet intervention 2: Hydrocodone Bitartrate (3.33 mg q4h X 3) intervention 3: Humibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3) | intervention 1: Humibid® intervention 2: Hydrocodone Bitartrate intervention 3: Humibid® and Hydrocodone Bitartrate tablet | 0 | null | 0 | NCT03642873 | |
[
3
] | 234 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study was designed to evaluate the efficacy and safety in major depressive disorder patients. | null | Depressive Disorder | MDD | null | 0 | null | null | 1 | [
0
] | intervention 1: Study drug | intervention 1: bupropion hydrochloride | 7 | Fukuoka | N/A | Japan | 130.41667 | 33.6
Hyōgo | N/A | Japan | 144.43333 | 43.36667
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kumamoto | N/A | Japan | 130.69181 | 32.80589
Saitama | N/A | Japan | 139.65657 | 35.90807
Tokyo | N/A | Japan | 139.69171 | 35.6895
N/A | N/A | N/A | N/A | N/A | 0 | NCT00135512 |
[
4
] | 66 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting. | null | Epilepsy, Tonic-clonic | Monotherapy Epilepsy Keppra Levetiracetam | null | 1 | arm 1: Subjects received open-label Levetiracetam. | [
0
] | 1 | [
0
] | intervention 1: Pharmaceutical form: oral tablets Route of administration: Oral use | intervention 1: Levetiracetam | 21 | Beroun | N/A | Czechia | 14.072 | 49.96382
Brno | N/A | Czechia | 16.60796 | 49.19522
České Budějovice | N/A | Czechia | 14.47434 | 48.97447
Prague | N/A | Czechia | 14.42076 | 50.08804
Rychnov nad Kněžnou | N/A | Czechia | 16.27488 | 50.16284
Budapest | N/A | Hungary | 19.04045 | 47.49835
Debrecen | N/A | Hungary | 21... | 0 | NCT00150813 |
[
4
] | 248 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages 10-17 years with Heterozygous Familial Hypercholesterolemia. | This study consisted of 3 distinct periods. In Period 1, subjects received daily treatment for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin monotherapy group. Subjects in the ezetimibe with simvastatin group received one of three treatments: coadministration of ezetimibe 10 ... | Hypercholesterolemia | cholesterol drugs hypercholesterolemia adolescent randomized controlled trials | null | 2 | arm 1: Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg arm 2: Pooled subjects who received ezetimibe matching placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks intervention 2: Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe... | intervention 1: ezetimibe with simvastatin intervention 2: simvastatin | 0 | null | 1 | NCT00129402 |
[
4
] | 2,235 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | true | 1FEMALE | false | This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary. | null | Contraception | pregnancy prevention oral contraceptives | null | 1 | arm 1: Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles. | [
0
] | 1 | [
0
] | intervention 1: Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutive... | intervention 1: DR-1011 | 55 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
San Diego | California | Unite... | 0 | NCT00196326 |
[
3
] | 412 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | null | To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar ... | null | Low Bone Mineral Density | bone loss osteoporosis | null | 9 | arm 1: Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42. arm 2: Participants received denosumab 6 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month ... | [
2,
0,
0,
0,
0,
0,
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Placebo subcutaneous injection intervention 2: Denosumab for subcutaneous injection intervention 3: Alendronate 70 mg tablets | intervention 1: Placebo intervention 2: Denosumab intervention 3: Alendronate | 0 | null | 0 | NCT00043186 |
[
4
] | 211 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis. | On enrollment, participants underwent randomization in a 1:1 ratio to receive placebo or etanercept during the initial double-blind period. Participants could enter an escape group and receive open-label etanercept until week 12 if, at or after week 4, their Psoriasis Area and Severity Index (PASI) score either increas... | Psoriasis | Pediatric Psoriasis | null | 2 | arm 1: Participants received placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baselin... | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week intervention 2: Placebo matching to etanercept administered by subcutaneous injection once a week | intervention 1: Etanercept intervention 2: Placebo | 0 | null | 0 | NCT00078819 |
[
3
] | 512 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | null | The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-resp... | null | Arthroplasty, Replacement, Knee Venous Thrombosis | null | 4 | arm 1: Dabigatran etexilate 110 mg capsule, once a day, oral administration arm 2: Dabigatran etexilate 150 mg capsule, once a day, oral administration arm 3: Dabigatran etexilate 110 mg capsule, 2capsules, once a day, oral administration arm 4: matching placebo capsule, once a day, oral administration | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: Dabigatran etexilate 110 mg capsule, once a day, oral administration intervention 2: Dabigatran etexilate 150 mg capsule, once a day, oral administration intervention 3: Dabigatran etexilate 220 mg capsule, once a day, oral administration intervention 4: matching placebo capsule, once a day, oral admini... | intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Dabigatran Etexilate intervention 4: placebo | 38 | Eniwa, Hokkaido | N/A | Japan | 141.576 | 42.89357
Fukuoka, Fukuoka | N/A | Japan | N/A | N/A
Hachioji, Tokyo | N/A | Japan | N/A | N/A
Hirosaki, Aomori | N/A | Japan | N/A | N/A
Hiroshima, Hiroshima | N/A | Japan | N/A | N/A
Iida, Nagano | N/A | Japan | N/A | N/A
Izumisano, Osaka | N/A | Japan | N/A | N/A
Izunokuni,Sh... | 0 | NCT00246025 | |
[
5
] | 104 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion injuries. There is now increasing evidence that reactive oxygen species cause reperfusion injury. This study was designed to examine the effects... | Initial AMI patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. We compared infarct size, using serial determination of serum biomarkers and Q wave formations, and the incidence of reperfusion arrhythmia between the groups. Cardiovascular event-free curves w... | Myocardial Infarction Reperfusion Injury | Edaravone Randomized Control Trial ST-Elevation Myocardial Infarction Coronary Angioplasty | null | 2 | arm 1: Edaravone Group arm 2: Placebo Group | [
1,
4
] | 1 | [
0
] | intervention 1: intravenous administration of 30mg Edaravone just before reperfusion therapy | intervention 1: edaravone | 1 | Kumamoto | N/A | Japan | 130.69181 | 32.80589 | 0 | NCT00265239 |
[
4
] | 527 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with metformin in adults with type 2 diabetes mellitus. | There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, ... | Diabetes Mellitus | Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks. | intervention 1: Alogliptin and metformin intervention 2: Alogliptin and metformin intervention 3: Metformin | 56 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Artesia | California | United States | -118.08312 | 33.86585
Fresno | California | United States | -119.77237 | 36.74773
Los Angeles | California | United States | -118.24368 | 34.05223
Mission Viejo | ... | 0 | NCT00286442 |
[
4
] | 500 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus. | There are approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies among racial and ethnic populations and has been shown to correlate with age, obesity, family history, history of gestational diabetes, ... | Diabetes Mellitus | Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Dyslipidemia Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks. | intervention 1: Alogliptin and glyburide intervention 2: Alogliptin and glyburide intervention 3: Glyburide | 68 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Anaheim | California | United States | -117.9145 | 33.83529
Artesia | California | United States | -118.08312 | 33.86585
Fresno | California | Uni... | 0 | NCT00286468 |
[
5
] | 44 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | This is a double-blind, randomized, placebo-controlled, five-period crossover study to examine the likability of a repeated administration of immediate release methylphenidate hydrochloride (IR-MPH 40 mg) and OROS®-MPH (CONCERTA® 72 mg) in healthy adults. Hypotheses are as follows:
* Hypothesis 1: the subjective feeli... | The main goal of this study is to assess whether the abuse liability potential of delayed, repeated administrations of different formulations of MPH is moderated by the oral delivery system in which a delivery system with slower onset may be safer than one with more rapid early release. To this end, the investigators w... | Healthy | healthy volunteers | null | 5 | arm 1: OROS-Methylphenidate Will be administered during the first part of the day, and again during the separate part of the day. arm 2: Immediate release methylphenidate will be administered in the first part of the day followed by Immediate release methylphenidate in the second part of the day. arm 3: Placebo will be... | [
0,
0,
2,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Each dose of OROS MPH will be 72 mg which will be supplied as two 36 mg overencapsulated capsules intervention 2: Each dose of IR MPH will be 40 mg which will be supplied as two 20 mg overencapsulated capsules intervention 3: Placebo will be administered during the first part of the day, and again durin... | intervention 1: OROS-Methylphenidate intervention 2: Immediate Release Methylphenidate intervention 3: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00302458 |
[
5
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 1FEMALE | null | This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The an... | null | Post Menopausal Osteoporosis | null | 2 | arm 1: Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months. arm 2: Participants received a matching placebo tablet to Ibandronate once-monthly along wit... | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: po monthly for 6 months intervention 2: As prescribed intervention 3: 150mg po monthly for 6 months | intervention 1: Placebo intervention 2: Vitamin D and calcium supplementation intervention 3: ibandronate [Bonviva/Boniva] | 10 | Beverly Hills | California | United States | -118.40036 | 34.07362
La Jolla | California | United States | -117.2742 | 32.84727
Augusta | Georgia | United States | -81.97484 | 33.47097
Woodbury | Minnesota | United States | -92.95938 | 44.92386
The Bronx | New York | United States | -73.86641 | 40.84985
Hopwood | Penns... | 0 | NCT00303485 | |
[
5
] | 137 | NON_RANDOMIZED | PARALLEL | null | 1SINGLE | false | 0ALL | null | Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora | null | Bacterial Conjunctivitis | null | 2 | arm 1: Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days. arm 2: Healthy Subjects receiving no treatment | [
0,
4
] | 1 | [
0
] | intervention 1: 1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days | intervention 1: VIGAMOX | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00312338 | |
[
3
] | 201 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI). | null | Coronary Artery Disease | null | 2 | arm 1: One time oral loading dose (LD) of 60-mg Prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10-mg Prasugrel and placebo matched to clopidogrel taken orally once a day for 14 days. Patients cross-over to 150 mg clopidogrel and placebo matche... | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally | intervention 1: Prasugrel intervention 2: Clopidogrel intervention 3: Placebo for Prasugrel intervention 4: Placebo for Clopidogrel | 16 | Jacksonville | Florida | United States | -81.65565 | 30.33218
Worcester | Massachusetts | United States | -71.80229 | 42.26259
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Rapid City | South Dakota | United States | -103.23101 | 44.08054
Lille | N/A | France | 3.05858 | 50.63297
Marseille | N/A | France ... | 0 | NCT00357968 | |
[
2,
3
] | 27 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed disodium may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of... | OBJECTIVES:
Primary
* Determine the safety, including dose-limiting toxicities, and feasibility of combining bortezomib with pemetrexed disodium in patients with advanced non-small cell lung cancer (NSCLC) or other solid tumors. (Phase I)
* Determine the response rate in patients with advanced NSCLC treated with this... | Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific | recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific | null | 0 | null | null | 9 | [
0,
0,
6,
6,
6,
6,
10,
10,
10
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None | intervention 1: bortezomib intervention 2: pemetrexed disodium intervention 3: gene expression analysis intervention 4: mutation analysis intervention 5: protein expression analysis intervention 6: reverse transcriptase-polymerase chain reaction intervention 7: flow cytometry intervention 8: immunoenzyme technique inte... | 1 | Sacramento | California | United States | -121.4944 | 38.58157 | 0 | NCT00389805 |
[
3
] | 903 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | null | This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits. | null | Thrombosis Hip Replacement | Anti-coagulant hip replacement hip replacement surgery unilateral hip replacement surgery DeepVein Thrombosis Venous Thromboembolism pulmonary embolism Prevention of Blood Clots | null | 0 | null | null | 1 | [
0
] | intervention 1: None | intervention 1: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor | 29 | Hartford | Connecticut | United States | -72.68509 | 41.76371
Sarasota | Florida | United States | -82.53065 | 27.33643
Austin | Texas | United States | -97.74306 | 30.26715
Ajax | Ontario | Canada | -79.03288 | 43.85012
Cambridge | Ontario | Canada | -80.31269 | 43.3601
Guelph | Ontario | Canada | -80.25599 | 43.54594... | 0 | NCT00398216 |
[
4
] | 34 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture. | Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the o... | Spinal Puncture | Lumbar Puncture Pediatrics Propofol Remifentanil sedation Oncology | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus. intervention 2: Patients in this arm ... | intervention 1: Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg intervention 2: Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00405522 |
[
4
] | 426 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score. | null | Seasonal Allergic Rhinitis | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning intervention 2: Two sprays in each nostril once daily in the morning | intervention 1: mometasone furoate intervention 2: Placebo | 0 | null | 0 | NCT00453063 | |
[
2,
3
] | 48 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | 1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma
3. To determine the effec... | Treatment:
High-dose melphalan followed by a transplant of autologous stem cells is thought to be one of the most effective ways to treat multiple myeloma. However, the number one cause of treatment failure in these patients is the disease coming back.
High-dose melphalan has been used in multiple myeloma for more th... | Multiple Myeloma Stem Cell Transplantation | Multiple Myeloma Ascorbic Acid Vitamin C Arsenic Trioxide Trisenox Melphalan Autologous Stem Cell Transplant Stem Cell Transplantation | null | 1 | arm 1: Arsenic Trioxide + Ascorbic Acid + Melphalan as a preparative regimen for autologous stem cell transplantation (delivered on Day 0) | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Dose Level 1: None; Dose Level 2: 0.15 mg/kg days Intravenous (IV) Days -9 to -3; Dose Level 3: 0.25 mg/kg days IV Days -9 to -3. intervention 2: Dose Levels 1, 2, \& 3: 100 mg/m2 IV Days -4, -3. intervention 3: Dose Levels 1, 2, \& 3: 1000 mg IV Days -9 to -3. | intervention 1: Arsenic Trioxide intervention 2: Melphalan intervention 3: Ascorbic Acid | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00661544 |
[
4
] | 380 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | false | The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain. | This was a 38 week, multicentre, open label (Part A) follow-on study to evaluate, the maintenance of effect of, the development of tolerance through exposure to, and safety of, Sativex® in the treatment of subjects with neuropathic pain. The study provided continued availability of Sativex® to subjects who completed th... | Pain Peripheral Neuropathy | Pain Peripheral Neuropathy | null | 1 | arm 1: Active treatment | [
0
] | 1 | [
0
] | intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours | intervention 1: Sativex® | 1 | Solihull | West Midlands | United Kingdom | -1.78094 | 52.41426 | 0 | NCT00713323 |
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