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
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be an effective way to kill more tumor cells.
PUR... | OBJECTIVES:
Primary
* To evaluate the efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix
Secondary
* To document any side effects directly attributed to local administration of gemcitabine hydrochloride.
OUTLINE: Patients undergo application of topical gemcitabine hydro... | Cervical Cancer Endometrial Cancer Ovarian Cancer | recurrent cervical cancer cervical cancer endometrial carcinoma ovarian epithelial cancer recurrent ovarian epithelial cancer recurrent endometrial carcinoma | null | 1 | arm 1: CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tis... | [
0
] | 2 | [
0,
3
] | intervention 1: Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device. intervention 2: hysterectomy | intervention 1: topical gemcitabine hydrochloride intervention 2: therapeutic conventional surgery | 1 | Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00610740 |
[
0
] | 16 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 1FEMALE | false | The purpose of this study is to examine the efficacy of atomoxetine (ATX) treatment for the mild to moderate cognitive disturbances frequently experienced by women during the menopause transition. In addition, we seek to determine, using the Brown Attention Deficit Disorder Scale (BADDS), whether and to what degree per... | Decline in cognitive function, and in particular memory, is a frequent complaint for which menopausal women seek clinical intervention. While there is a wealth of preclinical evidence demonstrating the neuroprotective and cognitive enhancing role of estradiol (Wise et al., 1999; Jezierski \& Sohrabji, 2001), recent pub... | Menopause Cognitive Disturbances | Menopause Cognition | null | 2 | arm 1: Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washo... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. intervention 2: Subjects will receive placebo equiva... | intervention 1: atomoxetine intervention 2: placebo | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00611533 |
[
4
] | 117 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | null | To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or o... | null | Relapsing Multiple Sclerosis | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Form... | intervention 1: Rebif New Formulation + prophylactic Ibuprofen intervention 2: Rebif New Formulation + ibuprofen PRN | 2 | Paris | N/A | France | 2.3488 | 48.85341
Munich | N/A | Germany | 11.57549 | 48.13743 | 0 | NCT00619307 | |
[
3
] | 24 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 1FEMALE | false | This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT). | null | Osteoporosis | null | 3 | arm 1: Oral Tablet arm 2: Oral Tablet arm 3: Nasal Spray | [
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4. intervention 2: 0.15 mgs recombinant salmon calcitonin, single oral dose intervention 3: 0.2mgs recombinant salmon calcitonin, single oral tablet intervention 4: 200 IU recombinant salmon calcitonin, single in... | intervention 1: Recombinant Salmon Calcitonin (rsCT) intervention 2: Oral Tablet intervention 3: Oral Tablet intervention 4: Nasal Spray | 1 | Springfield | Missouri | United States | -93.29824 | 37.21533 | 0 | NCT00620854 | |
[
3
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections | null | Infectious Skin Diseases Bacterial Skin Diseases Staphylococcal Skin Infections Streptococcal Infections Abscess | null | 3 | arm 1: Radezolid 450 mg PO QD arm 2: Radezolid 450 mg PO BID arm 3: Linezolid 600 mg PO BID | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: 450mg PO QD intervention 2: 450mg PO BID intervention 3: 600mg PO BID | intervention 1: Radezolid intervention 2: Radezolid intervention 3: Linezolid | 19 | Montgomery | Alabama | United States | -86.29997 | 32.36681
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | California | United States | -118.14452 | 34.14778
Sylmar | California | United States | -118.44925 | 34.30778
Atlantis ... | 0 | NCT00646958 | |
[
4
] | 607 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone) | This will be a Phase III, randomized, double-blind, parallel-group study in subjects with moderate-to-severe SAR. The study will be conducted at 8 investigational sites during the 2007-2008 Texas Mountain Cedar allergy season. After a 7-day Placebo Lead-In Period (Day -7 to Day 1), subjects will be instructed to take p... | Seasonal Allergic Rhinitis | null | 4 | arm 1: azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray arm 2: azelastine Hcl 548 mcg nasal spray arm 3: fluticasone propionate 200 mcg nasal spray arm 4: placebo nasal spray | [
0,
1,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day intervention 2: azelastine Hcl nasal spray one spray per nostril two times a day intervention 3: fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day intervention 4: placebo ... | intervention 1: MP29-02 intervention 2: azelastine Hcl intervention 3: fluticasone propionate intervention 4: placebo | 7 | Austin | Texas | United States | -97.74306 | 30.26715
New Braunfels | Texas | United States | -98.12445 | 29.703
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Waco | Texas | United States |... | 0 | NCT00660517 | |
[
4
] | 536 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone. | null | Seasonal Allergic Rhinitis | null | 2 | arm 1: Placebo arm 2: 0.15% Azelastine Hydrochloride | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Placebo intervention 2: 0.15% Azelastine Hydrochloride 822 mcg | intervention 1: Placebo intervention 2: 0.15% Azelastine Hydrochloride | 6 | Austin | Texas | United States | -97.74306 | 30.26715
Austin | Texas | United States | -97.74306 | 30.26715
New Braunfels | Texas | United States | -98.12445 | 29.703
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Waco | Texas | United States | -97.... | 0 | NCT00660829 | |
[
4
] | 60 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model. | Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is ... | Healthy Subjects Partial Denture Wearers Caries | remineralization enamel fluoride caries in situ | null | 5 | arm 1: Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 2: Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm... | [
1,
0,
1,
1,
2
] | 2 | [
0,
0
] | intervention 1: Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F intervention 2: Fluoride free toothpaste (0 ppm F) | intervention 1: Sodium fluoride toothpaste intervention 2: Placebo toothpaste | 0 | null | 0 | NCT00708123 |
[
5
] | 250 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for... | Same as above. | Plaque Psoriasis | null | 2 | arm 1: clobetasol propionate spray 0.05% arm 2: clobetasol propionate ointment 0.05% | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Apply twice daily intervention 2: Apply twice daily | intervention 1: clobetasol propionate spray intervention 2: clobetasol propionate ointment | 6 | Fremont | California | United States | -121.98857 | 37.54827
Vallejo | California | United States | -122.25664 | 38.10409
Detroit | Michigan | United States | -83.04575 | 42.33143
Fridley | Minnesota | United States | -93.26328 | 45.08608
Rochester | New York | United States | -77.61556 | 43.15478
Dallas | Texas | Unit... | 0 | NCT00733954 | |
[
4
] | 25 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products. | The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control. | Gingival Diseases | null | 3 | arm 1: None arm 2: None arm 3: None | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Brush twice daily intervention 2: Half mouth toothbrushing twice daily for 4 days intervention 3: Mouth rinsing twice a day for 4 days | intervention 1: Fluoride intervention 2: Triclosan/Fluoride intervention 3: Chlorhexidine Gluconate | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00759187 | |
[
4
] | 39 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis. | null | Gingival Diseases | null | 2 | arm 1: Fluoride toothpaste (Colgate Great Regular Flavor) is the control for this study. All study toothpastes contain fluoride. The study is evaluating the additional ingredients in the other toothpastes. arm 2: fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste) | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Brush twice daily for 6 weeks intervention 2: Brush twice daily | intervention 1: Fluoride intervention 2: Fluoride, triclosan | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00763048 | |
[
5
] | 111 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks. | To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks. | Glaucoma | Glaucoma | null | 2 | arm 1: Travoprost 0.004% arm 2: Timolol 0.5% | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Travoprost at 9 AM + Placebo \& 9 PM intervention 2: Timolol in each eye, twice daily at 9 AM \& 9 PM | intervention 1: Travoprost 0.004% Ophthalmic Solution (Travatan) intervention 2: Timolol 0.5% Ophthalmic Solution (Timoptic) | 1 | Fort Worth | Texas | United States | -97.32085 | 32.72541 | 0 | NCT00763061 |
[
2
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test). | null | Healthy | certolizumab pegol Cimzia bioequivalence Comparison Bioequivalence Study | null | 2 | arm 1: pre-filled syringe (reference) arm 2: Auto-injection device (test) | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections intervention 2: Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections | intervention 1: Certolizumab pegol intervention 2: Certolizumab pegol | 1 | Rennes | N/A | France | -1.67429 | 48.11198 | 0 | NCT00845663 |
[
0
] | 54 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine which pain management strategy continuous analgesic pump or orally-should be used in the management of children with cerebral palsy. | A prospective randomized controlled trial will be performed on up to 150 subjects who will undergo a tendoachilles lengthening, Strayer's procedure, epiphysiodesis of the femur or femoral osteotomy metal work removal.
Subjects will be randomized into two groups: the first group will have an anesthetic pain pump device... | Cerebral Palsy | Pain Pain management Cerebral Palsy | null | 2 | arm 1: Group 1 will receive oral analgesic only arm 2: Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia | [
1,
1
] | 2 | [
0,
0
] | intervention 1: per clinical standard of care intervention 2: per clinical standard of care | intervention 1: oral analgesic intervention 2: intravenous analgesic per pump | 1 | Aurora | Colorado | United States | -104.83192 | 39.72943 | 0 | NCT00884650 |
[
5
] | 234 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants wit... | This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater... | Arthritis, Rheumatoid | Arthritis, Rheumatoid Infliximab Methotrexate | null | 2 | arm 1: Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score \[DAS\] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable ... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22. intervention 2: MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks. | intervention 1: Infliximab intervention 2: Methotrexate | 0 | null | 0 | NCT00896168 |
[
4
] | 98 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation. | null | Dental Plaque | null | 3 | arm 1: Winterfresh Gel arm 2: Positive control (Total toothpaste) arm 3: test toothpaste | [
2,
1,
0
] | 3 | [
0,
0,
10
] | intervention 1: Brush twice daily intervention 2: Brush twice daily intervention 3: Brush twice daily | intervention 1: Fluoride intervention 2: Triclosan, fluoride intervention 3: Metal salt | 1 | Cedar Knolls | New Jersey | United States | -74.44876 | 40.82204 | 0 | NCT00926029 | |
[
2
] | 158 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors.
The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response ... | null | Carcinoma | Sorafenib Advanced Solid Tumors Maximum tolerated dose Carboplatin and paclitaxel chemotherapy combination | null | 5 | arm 1: Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 2: Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). ... | [
0,
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet) intervention 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet) intervention 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet) intervention 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg... | intervention 1: Sorafenib 100 mg (50-mg tablet) intervention 2: Sorafenib 200 mg (50-mg tablet) intervention 3: Sorafenib 400 mg (50-mg tablet) intervention 4: Sorafenib 400 mg (200-mg tablet) intervention 5: Sorafenib 400 mg (Expansion) | 3 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Nashville | Tennessee | United States | -86.78444 | 36.16589
Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00941863 |
[
0
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Although Attention Deficit/ Hyperactive Disorder (ADHD) is a common comorbidity in individuals diagnosed with Substance Use Disorder (SUD), little data currently exists on the utility of screening tools in large samples of adult patients with SUD in inpatient treatment. This was a 10-week, 2-phase, open label trial of ... | Phase 1: Patients with SUD who were either newly admitted (abstinent for \<1 week) or in treatment in the RTF (abstinent \<3 months) were administered the Adult ADHD Self-Report Scale Symptom Checklist (ASRS) v. 1.1 Screener. Patients who screened positive(\>= 4 out 6 significant items) were then administered the Adult... | Attention Deficit Hyperactivity Disorder | ADHD Substance Use Disorder Residential Treatment Facility | null | 1 | arm 1: Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 120 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side-effects. All patients receiving atomoxetine gave written i... | [
0
] | 1 | [
0
] | intervention 1: In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant at the optimized level for the final 6 weeks of the trial. | intervention 1: Atomoxetine | 0 | null | 0 | NCT00953862 |
[
4
] | 22 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse | Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available. | Dental Plaque | null | 3 | arm 1: negative control toothpaste arm 2: positive control toothpaste (Total toothpaste) arm 3: positive control oral rinse | [
2,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Brush half mouth twice daily for four days. intervention 2: Brush twice daily intervention 3: Rinse mouth twice a day | intervention 1: Fluoride intervention 2: Triclosan, fluoride intervention 3: Chlorhexidine Gluconate | 1 | Paramus | New Jersey | United States | -74.07542 | 40.94454 | 0 | NCT01024738 | |
[
0
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye. The disease can cause different symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients respond to a gluten-free diet. However some ... | A symptom questionnaire will be administered at study initiation, 2 weeks and 12 weeks. Patients will undergo a breath test which involves drinking a sugar (lactulose) solution and breathing into a machine. This technique will identify the presence of bacteria in the small intestine. They will be randomly selected to r... | Celiac Disease | Gastrointestinal Symptom Rating Scale (GSRS) Poorly responsive Refractory Small intestine bacterial overgrowth Breath test | null | 2 | arm 1: Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days. arm 2: Placebo pills given 3 times a day for 10 days. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Rifaximin 400mg orally three times a day for 10 days total intervention 2: Placebo orally three times a day for 10 days total | intervention 1: Rifaximin intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT01137955 |
[
3,
4
] | 230 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose. | Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV)... | Type 2 Diabetes Mellitus | Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 3: Alogliptin placebo-match... | intervention 1: Alogliptin and voglibose intervention 2: Alogliptin and voglibose intervention 3: Voglibose | 0 | null | 0 | NCT01263483 |
[
3
] | 56 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions ... | This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (Each group of participants will be treated at the same time), comparison study to... | Schizophrenia | Schizophrenia Paliperidone Palmitate JNS010 | null | 4 | arm 1: Paliperidone palmitate 50 milligram (mg) intramuscular (into the muscle) injection on Days 1, 8, 36 and 64. arm 2: Paliperidone palmitate 100 mg intramuscular injection on Days 1, 8, 36 and 64. arm 3: Paliperidone palmitate 150 mg intramuscular injection on Days 1, 8, 36 and 64. arm 4: Paliperidone palmitate 150... | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: Paliperidone palmitate aqueous suspension for injection 0.5, 1.0, 1.5 milliliter equivalent to 50, 100, 150 mg paliperidone respectively as intramuscular injection on Days 1, 8, 36 and 64. | intervention 1: Paliperidone palmitate | 1 | Ichikawa | N/A | Japan | 139.9065 | 35.73413 | 0 | NCT01606254 |
[
3
] | 174 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Reco... | null | Parkinson's Disease | SPM 962 rotigotine Parkinson's disease concomitant use of L-dopa | null | 2 | arm 1: SPM 962 transdermal patch arm 2: Placebo transdermal patch | [
0,
2
] | 2 | [
0,
0
] | intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day intervention 2: Placebo transdermal patch | intervention 1: SPM 962 intervention 2: Placebo | 7 | Chubu Region | N/A | Japan | N/A | N/A
Hokkaido Region | N/A | Japan | N/A | N/A
Kanto Region | N/A | Japan | N/A | N/A
Kinki Region | N/A | Japan | N/A | N/A
Kyushu Region | N/A | Japan | N/A | N/A
Shikoku Region | N/A | Japan | N/A | N/A
Tohoku Region | N/A | Japan | N/A | N/A | 0 | NCT01628848 |
[
3
] | 56 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 3TRIPLE | false | 0ALL | true | The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery. | The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients in either group. Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation cri... | Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma | Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma Pediatrics Clonidine Bupivacaine Greater Auricular Nerve Block Regional Anesthesia | null | 2 | arm 1: This is our standard of care concentration arm 2: These are not two separate drugs, but a mixture of Bupivacaine and Clonidine. | [
4,
0
] | 1 | [
0
] | intervention 1: Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine | intervention 1: 0.25% Bupivacaine + Clonidine | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT01638052 |
[
4
] | 14 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded acces... | This is an open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than 1 center) study to assess the PK of bortezomib and to provide expanded access to bortezomib for 14 Taiwanese participants with multiple myeloma who have received at least 2 previous lines of therap... | Multiple Myeloma | Multiple Myeloma Bortezomib Velcade | null | 1 | arm 1: Bortezomib 1.3 milligram (mg) per meter square (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles. | [
0
] | 1 | [
0
] | intervention 1: Bortezomib 1.3 mg per (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles. | intervention 1: Bortezomib | 0 | null | 0 | NCT01801436 |
[
3
] | 18 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months. | null | Breast Cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles intervention 2: 75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles intervention 3: 950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks | intervention 1: bevacizumab [Avastin] intervention 2: docetaxel intervention 3: capecitabine [Xeloda] | 1 | Salzburg | N/A | Austria | 13.04399 | 47.79941 | 0 | NCT02005549 | |
[
5
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 indivi... | null | Colorectal Cancer | null | 1 | arm 1: Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study. | [
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor. intervention 2: Bevacizumab will be administered IV 5 mg/kg every ... | intervention 1: 5-Fluorouracil intervention 2: Bevacizumab intervention 3: Irinotecan intervention 4: Oxaliplatin | 8 | Chai Yi | N/A | Taiwan | N/A | N/A
Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626
Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Tainan City | N/A | Taiwan | 120.21333 | 22.99083
Tainan City | N/A | Taiwan | 120.21333 ... | 0 | NCT02582970 | |
[
3
] | 12 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 2MALE | false | Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men. | Five period cross-over study in which subjects received a single day of dosing in each period. Dosing was either QD or BID with one of two T esters (T-enanthate (TE) or T-undecanoate (TU)). Dosing was within 5 minutes of meals (breakfast and for BID dosing dinner). There was a minimum of a 5-day washout between periods... | Hypogonadism | testosterone male hypogonadism low testosterone | null | 2 | arm 1: Period 2 - 200 mg T (as TU) QD Period 3 - 200 mg T (as TU) BID (100 mg/dose) Period 4 - 400 mg T (as TU) BID (200 mg/dose) arm 2: Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Single-day dose as QD or BID for 3 of 5 crossover periods intervention 2: Single-day dose for 2 of 5 crossover periods | intervention 1: Testosterone undecanoate intervention 2: Testosterone enanthate | 2 | Los Angeles | California | United States | -118.24368 | 34.05223
San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT02697188 |
[
2
] | 11 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic Lymphoma (SLL). | This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of CAT-8015 in relapsed or refractory participants with CLL, PLL, or SLL. Participants in the initial dose cohort were to receive CAT-8015 at a dose of 5 microgram per kilogram (mcg/kg) CAT-8015, incr... | Leukemia, Lymphoma, Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Small Lymphocytic Lymphoma, Moxetumomab Pasudotox | Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Small Lymphocytic Lymphoma Moxetumomab pasudotox | null | 3 | arm 1: Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. arm 2: Participants received a single intravenous infusion of 10 mcg... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. intervention 2: Participants received a single intravenous ... | intervention 1: CAT-8015 5 mcg/kg intervention 2: CAT-8015 10 mcg/kg intervention 3: CAT-8015 20 mcg/kg | 3 | Indianapolis | Indiana | United States | -86.15804 | 39.76838
Bethesda | Maryland | United States | -77.10026 | 38.98067
Lodz | N/A | Poland | 19.47395 | 51.77058 | 0 | NCT00587457 |
[
4
] | 207 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack. | null | Migraine | null | 2 | arm 1: Active Drug arm 2: Matching Pbo Comparator | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack intervention 2: Matching placebo; one dose, treatment of a single migraine attack | intervention 1: Comparator: rizatriptan benzoate intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00516737 | |
[
2
] | 24 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of telcagepant and sumatriptan is similar to that following administration of sumatriptan alone. That ... | null | Migraine Disorders | null | 4 | arm 1: Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dos... | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Single oral dose of 2 x 300 mg capsules. intervention 2: single oral dose of 100 mg sumatriptan intervention 3: single oral dose intervention 4: single oral dose of 2 MK-0974 placebo capsules | intervention 1: telcagepant potassium intervention 2: sumatriptan intervention 3: sumatriptan placebo intervention 4: telcagepant potassium placebo | 0 | null | 0 | NCT00701389 | |
[
2
] | 12 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | true | 1FEMALE | false | An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. | This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B... | Healthy | PK Pharmacokinetics | null | 3 | arm 1: Single dose of Proellex 25 mg formulation A, fed arm 2: Single dose of Proellex 25 mg formulation B, fed arm 3: Single dose of Proellex 25 mg formulation B, fasted | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: One Proellex 25 mg formulation A capsule intervention 2: One 25 mg Proellex capsule formulation B administered both fed and fasted | intervention 1: Proellex 25 mg formulation A intervention 2: Proellex 25 mg formulation B | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00620503 |
[
5
] | 719 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | null | This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also recei... | null | Post-Menopausal Osteoporosis | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 150mg po monthly for 3 years intervention 2: 100mg po monthly for 3 years | intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] | 31 | Loma Linda | California | United States | -117.26115 | 34.04835
Lakewood | Colorado | United States | -105.08137 | 39.70471
Omaha | Nebraska | United States | -95.94043 | 41.25626
Livingston | New Jersey | United States | -74.31487 | 40.79593
Portland | Oregon | United States | -122.67621 | 45.52345
Liège | N/A | Belgi... | 1 | NCT00081653 | |
[
5
] | 948 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the... | null | Hepatitis C, Chronic | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: 1000/1200mg po daily for 72 weeks intervention 2: 1000/1200mg po daily for 48 weeks intervention 3: 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks intervention 4: 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks. intervent... | intervention 1: Ribavirin intervention 2: Ribavirin intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: peginterferon alfa-2a [Pegasys] intervention 5: peginterferon alfa-2a [Pegasys] intervention 6: peginterferon alfa-2a [Pegasys] | 104 | Mobile | Alabama | United States | -88.04305 | 30.69436
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Los Angeles | California | United States | -118.24368 | 34.05223
Pasadena | California | United States | -118.14452 | 34.14778
San Diego | California | United States | -117.16472 | 32.71571
Ukiah | Calif... | 1 | NCT00087646 | |
[
4
] | 11,506 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population. | null | Hypertension | cardiovascular morbidity cardiovascular mortality benazepril amlodipine high risk population | null | 2 | arm 1: Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a force... | [
0,
1
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily. intervention 2: Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily. intervention 3: Benazepril hydrochloride (HCl)/amlodipine besylate: 40/10 mg cap... | intervention 1: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1 intervention 2: Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2 intervention 3: Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter intervention 4: Benazepril/hydrochlorothiazide 20/1... | 5 | East Hanover | New Jersey | United States | -74.36487 | 40.8201
Denmark | N/A | Denmark | N/A | N/A
Finland | N/A | Finland | N/A | N/A
Norway | N/A | Norway | N/A | N/A
Sweden | N/A | Sweden | N/A | N/A | 0 | NCT00170950 |
[
3
] | 78 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insuffic... | null | Stomach Neoplasms | null | 1 | arm 1: 50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed | [
0
] | 1 | [
0
] | intervention 1: 50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed | intervention 1: Sunitinib | 18 | Nanjing | Jiangsu | China | 118.77778 | 32.06167
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Guangzhou | N/A | China | 113.25 | 23.11667
Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
Shatin | N/A | Hong Kong | 114.18333 | 22.38333
Ancona | N/A | Italy | 13.5103 | 43.6071... | 1 | NCT00226811 | |
[
4
] | 1,428 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebe... | null | Hepatitis C, Chronic | null | 2 | arm 1: Slow responders (defined as being polymerase chain reaction \[PCR\] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48. arm 2: Slow responders (defined as being PCR positive at Week 12 with at least 2 log reducti... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks
2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks intervention 2: 1. Powder for injection in vial or Redipen (50, 80, 100,... | intervention 1: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) intervention 2: Combination of pegylated interferon alfa-2b and ribavirin | 0 | null | 1 | NCT00265395 | |
[
4
] | 3,608 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will... | null | Deep Vein Thrombosis Pulmonary Embolism | Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery | null | 2 | arm 1: \+ placebo arm 2: \+ placebo | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period intervention 2: Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period | intervention 1: Enoxaparin + Placebo intervention 2: Apixaban + Placebo | 107 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Aurora | Colorado | United States | -104.83192 | 39.72943
Denver | Colorado | ... | 1 | NCT00371683 |
[
3
] | 235 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to compare hemoglobin response rates between two PROCRIT (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving chemotherapy | This is an open-label (both the physician and the patient know which treatment is being provided), multi-center study of up to 16 weeks duration in which 450 patients will be randomly assigned (patients are assigned to a specific study group by chance) to one of three treatment groups in a 1:1:1 ratio. Patients will re... | Neoplasms Anemia Cancer | Anemia Cancer Chemotherapy-Induced Anemia Epoetin alfa Darbepoetin alfa | null | 3 | arm 1: epoetin alfa (PROCRIT) 120,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks arm 2: epoetin alfa (PROCRIT) 80,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks arm 3: darbepoetin alfa (ARANESP) 500 mcg injected subcutaneously the skin once every 3 weeks for up to 13 we... | [
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: 80,000 Units and 120,000 Units of epoetin alfa (PROCRIT) injected subcutaneously once every 3 weeks for up to 13 weeks intervention 2: 500 mcg of darbepoetin alfa (ARANESP) injected subcutaneously the skin once every 3 weeks for up to 13 weeks | intervention 1: epoetin alfa intervention 2: darbepoetin alfa | 76 | Glendale | Arizona | United States | -112.18599 | 33.53865
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | United States | -117.9145 | 33.83529
Bakersfield | California | United States | -119.01871 | 35.37329
Corona | Califo... | 1 | NCT00386152 |
[
3
] | 342 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus). | null | Diabetes Mellitus, Type 2 | null | 6 | arm 1: MK0893 tablets totaling 80 mg once daily. arm 2: MK0893 tablets totaling 60 mg once daily. arm 3: MK0893 40 mg tablet once daily. arm 4: MK0893 20 mg tablet once daily. arm 5: Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks. arm 6: PLA tablets. 12 week treatment perio... | [
0,
0,
0,
0,
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose. intervention 2: Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks. intervention 3: Dose-matched placebo tablets to MK0893; taken orally once daily. intervention 4: Dose-m... | intervention 1: MK0893 intervention 2: Metformin intervention 3: Placebo to MK0893 intervention 4: Placebo to Metformin | 0 | null | 1 | NCT00479466 | |
[
3
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway g... | OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and toleranc... | Visual Pathway Glioma | visual pathway glioma not amenable to standard therapy visual pathway glioma not responding to standard therapy | null | 1 | arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. | [
0
] | 1 | [
0
] | intervention 1: Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal). | intervention 1: Antineoplaston therapy (Atengenal + Astugenal) | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00003477 |
[
3
] | 26 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells.
PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer. | OBJECTIVES:
* Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b.
* Determine the toxicity of this regimen in these patients.
* Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies.
OUTLINE... | Kidney Cancer | stage IV renal cell cancer recurrent renal cell cancer | null | 1 | arm 1: Weekly ATRA-IV with recombinant interferon alfa | [
0
] | 2 | [
2,
0
] | intervention 1: None intervention 2: None | intervention 1: recombinant interferon alfa intervention 2: tretinoin liposome | 2 | New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00003656 |
[
4
] | 186 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating patients who have stage III or stage IV non-small cell lung cancer. Chemotherapeutic agents are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse and growth even after initial response to t... | PRIMARY OBJECTIVES:
I. To determine whether oral administration of the carboxyaminoimidazole (CAI) is more effective than placebo in prolonging the overall survival in patients with non-small cell lung cancer stage III or stage IV non-small cell lung cancer who have been stable or had tumor regression following chemot... | Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer | null | 2 | arm 1: Patients receive oral carboxyamidotriazole daily. arm 2: Patients receive oral placebo daily | [
0,
2
] | 4 | [
0,
10,
3,
10
] | intervention 1: Given PO intervention 2: Given PO intervention 3: Ancillary studies intervention 4: Correlative studies | intervention 1: carboxyamidotriazole intervention 2: placebo intervention 3: quality-of-life assessment intervention 4: laboratory biomarker analysis | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00003869 | |
[
3
] | 34 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to da... | OBJECTIVES:
* Determine the feasibility and safety of paclitaxel, estramustine, carboplatin, and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer.
* Determine the progression-free survival and time to prostate specific antigen failure in patients treated with ... | Prostate Cancer | adenocarcinoma of the prostate stage III prostate cancer | null | 1 | arm 1: Patients with localized high-risk prostate cancer were treated with 4 cycles (16 weeks) of continuous weekly paclitaxel at 80 mg/m\^2 intravenously with estramustine at 280 mg orally 3 times a day for 5 days a week and carboplatin (area under the curve of 6) on Day 1 of every cycle followed by 3-dimensional conf... | [
0
] | 5 | [
0,
0,
0,
4,
0
] | intervention 1: AUC=6 week one of each 4 week cycle intervention 2: 2 tablets tid PO 5 of 7 days per week each 4 week cycle intervention 3: 80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle intervention 4: 77.4 Gy in 1.8 Gy fractions intervention 5: 7.5 mg IM injection once every 4 weeks for 6 months | intervention 1: carboplatin intervention 2: estramustine intervention 3: paclitaxel intervention 4: radiation therapy intervention 5: leuprolide or goserelin acetate | 23 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Baltimore | Maryland | United States | -76.61219 | 39.29038
Baltimore | Maryland | United States | -76.61219 | 39.29038
Worcester | Massachusetts | United States | ... | 0 | NCT00016913 |
[
3
] | 41 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer. | OBJECTIVES:
* Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma.
* Evaluate the safety and tolerability, in terms of the toxicity profile, of this drug in these patients.
* Determine the biologic activity of this drug, in terms of early disease progression, progression-free s... | Kidney Cancer | recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. | intervention 1: OSI-774 | 1 | San Antonio | Texas | United States | -98.49363 | 29.42412 | 0 | NCT00045487 |
[
3
] | 271 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma. | This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients ... | Liposarcoma Leiomyosarcoma | Trabectedin Yondelis ET-743 Ecteinascidin Anthracycline Ifosfamide Dexamethasone Intravenous Cancer Malignant Metastatic | null | 2 | arm 1: Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion. arm 2: Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infu... | [
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. intervention 2: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle. intervention 3: Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondel... | intervention 1: Yondelis intervention 2: Yondelis intervention 3: Dexamethasone intervention 4: Dexamethasone | 39 | Los Angeles | California | United States | -118.24368 | 34.05223
Aurora | Colorado | United States | -104.83192 | 39.72943
Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768
Park Ridge | Illinois | United States | -87.84062 | 42.01114
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Louisville |... | 0 | NCT00060944 |
[
4
] | 150 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This study will examine whether the addition of cognitive behavioral therapy can improve the efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder. Patients with social anxiety disorder will undergo a 12-week open trial with paroxetine. Those who complete the open trial hav... | Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified. Paroxetine is effective in treating the acute symptoms of social anxiety, but many patients achieve less than optimal response. CBT has also been effective in treating social anxiety disorder; ... | Social Anxiety Disorder | Social Phobia | null | 2 | arm 1: Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. arm 2: Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) f... | [
0,
0
] | 2 | [
0,
5
] | intervention 1: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. intervention 2: CBT will consist of 16 weekly treatment sessions. | intervention 1: Paroxetine intervention 2: Cognitive behavioral therapy (CBT) | 2 | New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00074802 |
[
3
] | 49 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | false | 1FEMALE | true | RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy.
PURPOSE: This randomized phase II trial is studying how well triptorelin works ... | OBJECTIVES:
Primary
* Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy.
Secondary
* Determine the rate of chemotherapy-rela... | Breast Cancer Hormone Changes Drug Toxicity | drug/agent toxicity by tissue/organ hormone changes stage I breast cancer stage II breast cancer | null | 2 | arm 1: GnRH analogue (triptorelin) during chemotherapy arm 2: No GnRH analogue (triptorelin) during chemotherapy | [
0,
4
] | 1 | [
0
] | intervention 1: 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection | intervention 1: triptorelin | 9 | Oakland | California | United States | -122.2708 | 37.80437
Tampa | Florida | United States | -82.45843 | 27.94752
Augusta | Georgia | United States | -81.97484 | 33.47097
Chicago | Illinois | United States | -87.65005 | 41.85003
Springfield | Missouri | United States | -93.29824 | 37.21533
Springfield | Missouri | Uni... | 0 | NCT00090844 |
[
3
] | 77 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome (MeS). | Individuals with the Metabolic Syndrome (MeS) are at increased risk for developing cardiovascular diseases. This increased risk may, in part, be related to abnormalities in the blood vessels. MeS is defined as having 3 or more of the following 5 criteria:
* Abdominal obesity (waist measurement \>39.8 inches in men, \>... | Obesity Hypertension Hypercholesterolemia Hyperglycemia | Metabolic Syndrome triglycerides HDL LDL High Blood Pressure High Cholesterol High Blood Sugar | null | 2 | arm 1: placebo arm 2: Metformin 850 mg twice daily | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 850mg tablet once a day for one month, then twice a day for 3 months intervention 2: placebo tablet once a day for one month, then twice a day for 3 months | intervention 1: Metformin intervention 2: Placebo | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00105066 |
[
4
] | 12,064 | RANDOMIZED | FACTORIAL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | SEARCH is a randomised, double-blind, multi-centre United Kingdom (UK) trial of 12,064 patients with myocardial infarction (MI) prior to study entry which aims to demonstrate whether a more intensive cholesterol lowering regimen using 80 mg simvastatin daily produces a larger and worthwhile reduction in cardiovascular ... | In observational studies, lower blood cholesterol concentrations are associated with lower coronary risk, without any clear threshold below which lower levels are not associated with lower risk. Cholesterol reduction with statins reduces such risk but there is uncertainty about whether greater reductions with more inte... | Cardiovascular Disease | Myocardial infarction Coronary heart disease Cholesterol Stroke | null | 4 | arm 1: Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily arm 2: Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily arm 3: Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo v... | [
1,
1,
1,
1
] | 4 | [
0,
7,
0,
0
] | intervention 1: Simvastatin 20 mg tablet once daily intervention 2: Folic acid 2 mg + vitamin B12 1 mg tablet once daily intervention 3: Simvastatin 80 mg tablet once daily intervention 4: Placebo vitamin B12/folic acid tablet once daily | intervention 1: Simvastatin 20 mg daily intervention 2: Folic acid 2 mg + vitamin B12 1 mg daily intervention 3: Simvastatin 80 mg daily intervention 4: Placebo | 1 | Oxford | Oxon | United Kingdom | -1.25596 | 51.75222 | 0 | NCT00124072 |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This study will examine the safety and effectiveness of a monoclonal antibody called humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis (JIA). Monoclonal antibodies are genetically engineered pr... | Pediatric uveitis represents 5-10 % of all patients with uveitis. Uveitis refers to intraocular inflammatory diseases. The most common type of non-infectious pediatric uveitis, associated with a systemic disease, is JIA-associated chronic, anterior uveitis. Therapeutic considerations for pediatric uveitis are often ver... | Anterior Uveitis Arthritis, Juvenile Idiopathic Iritis Immunosuppression | Anterior Uveitis Arthritis, Juvenile Idiopathic Daclizumab Iritis Immunosuppression Chronic Inflammatory Eye-Disease Juvenile Idiopathic Arthritis | null | 1 | arm 1: IV daclizumab | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Daclizumab | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00130637 |
[
5
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 1FEMALE | true | This study will determine the effects of St. John's wort, a common herbal remedy, on metabolism of the female contraceptive hormone levonorgestrel. | In the last decade, St. John's wort has become one of the most commonly used botanicals. Levonorgestrel is a form of progesterone, a female hormone involved in conception. It can be given as both a pill and an injection and is used for contraception and for the treatment of endometriosis. However, evidence suggests tha... | Contraception | Menstruation Complementary Therapies Pharmacokinetics Hypericum St. John's wort Levonorgestrel Women | null | 4 | arm 1: This group had baseline pharmacokinetic studies after an oral dose of levonorgestrel (LNG) 1.5 mg, then took a placebo herb daily for 4-6 weeks, during which time pharmacokinetic studies were repeated after an oral dose of LNG 1.5 mg arm 2: This group had baseline pharmacokinetic studies after an oral dose of le... | [
2,
1,
1,
1
] | 3 | [
7,
7,
0
] | intervention 1: Placebo herb three times daily (ground cellulose) for 4-6 weeks intervention 2: St. John's Wort (Hypericum perforatum) orally or 4-6 weeks intervention 3: Levonorgestrel in a single oral dose | intervention 1: Placebo Control (Placebo Herb) intervention 2: St. John's Wort intervention 3: Levonorgestrel | 1 | Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00131885 |
[
5
] | 43 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 0ALL | true | This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress disorder in acutely traumatized individuals. | Posttraumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of f... | Post-Traumatic Stress Disorder | Post-Traumatic Stress Disorder Prevention Propranolol Psychophysiology | null | 2 | arm 1: Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 da... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Propranolol short-acting or long-acting capsule intervention 2: Placebo-matching propranolol short-acting or long-acting capsule | intervention 1: Propranolol intervention 2: Placebo | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00158262 |
[
5
] | 233 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available. To evaluate the long-term safety and efficacy of deferasirox by measuring treatment success, change in liver iron content (LIC) and change in serum ferriti... | Iron accumulation is an inevitable consequence of chronic blood transfusions and results in serious complications in the absence of chelation treatment to remove excess iron. Deferasirox (Exjade, ICL670) is an oral chelator with high iron-binding potency and selectivity. This extension study aimed at collecting efficac... | Beta-thalassemia Major Hemosiderosis Iron Overload Rare Anemia | Transfusional hemosiderosis Beta-thalassemia major Deferasirox iron overload rare anemia iron overload due to transfusion | null | 1 | arm 1: Deferasirox was given orally once daily (10 to 20 mg/kg) to participants 2 years and older based on participant's body weight. | [
0
] | 1 | [
0
] | intervention 1: Deferasirox was administered orally once daily. Deferasirox was available as 125 mg, 250 mg, and 500 mg tablets. | intervention 1: Deferasirox | 5 | Cairo | N/A | Egypt | 31.24967 | 30.06263
Beirut | N/A | Lebanon | 35.50157 | 33.89332
Muscat | N/A | Oman | 58.40778 | 23.58413
Riyadh | N/A | Saudi Arabia | 46.72185 | 24.68773
Damascus | N/A | Syria | 36.29128 | 33.5102 | 0 | NCT00171301 |
[
3
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | RATIONALE: Licorice root extract contains ingredients that may slow the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving licorice root extract together with docetaxel may ... | OBJECTIVES:
Primary
* Determine the efficacy and toxicity of licorice root extract in combination with docetaxel in patients with hormone-refractory metastatic prostate cancer.
Secondary
* Determine the ability of licorice root extract to alter surrogate markers of estrogen activity and cytotoxicity in these patien... | Prostate Cancer | adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer | null | 1 | arm 1: None | [
0
] | 2 | [
7,
0
] | intervention 1: Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle. intervention 2: All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle. | intervention 1: licorice root extract intervention 2: docetaxel | 1 | New Brunswick | New Jersey | United States | -74.45182 | 40.48622 | 0 | NCT00176631 |
[
5
] | 69 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 0ALL | true | This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia. | The overall aim of this research study is to compare the symptoms, experiences and laboratory sleep characteristics of young adults with and without insomnia. Insomnia is a pattern of difficulty falling asleep, staying asleep or feeling poorly rested despite an adequate amount of time for sleep, which occurs nearly eve... | Sleep Disorders | Primary Insomnia Insomnia Placebo-Controlled Double-Blind Polysomnography PET Studies Escitalopram Zolpidem | null | 3 | arm 1: The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if ... | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to... | intervention 1: Zolpidem intervention 2: Escitalopram intervention 3: Placebo | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 0 | NCT00177216 |
[
4
] | 468 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two ... | The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare Pharmaceuticals Inc..
Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial. | Multiple Sclerosis | null | 2 | arm 1: Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase arm 2: Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial) | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase intervention 2: Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (=... | intervention 1: Interferon beta-1b (Betaseron, BAY86-5046) intervention 2: Interferon beta-1b (Betaseron, BAY86-5046) | 94 | Graz | N/A | Austria | 15.45 | 47.06667
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Vienna | N/A | Austria | 16.37208 | 48.20849
Brussels | N/A | Belgium | 4.34878 | 50.85045
Ghent | N/A | Belgium | 3.71667 | 51.05
Leuven | N/A | Belgium | 4.70093 | 50.87959
Liège | N/A | Belgium | 5.56749 | 50.63373
Calgary | Albe... | 0 | NCT00185211 | |
[
4
] | 394 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs. | 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. | Menopause | null | 1 | arm 1: Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defi... | [
0
] | 1 | [
0
] | intervention 1: LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical ana... | intervention 1: LNG IUS | 12 | Ghent | N/A | Belgium | 3.71667 | 51.05
Huy | N/A | Belgium | 5.23284 | 50.51894
Espoo | N/A | Finland | 24.6522 | 60.2052
Turku | N/A | Finland | 22.26869 | 60.45148
Turku | N/A | Finland | 22.26869 | 60.45148
Heerlen | N/A | Netherlands | 5.98154 | 50.88365
Venlo | N/A | Netherlands | 6.16806 | 51.37
Zaandam | N/A | ... | 0 | NCT00185458 | |
[
4
] | 139 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and ODD symptoms in patients non responders t... | null | Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder | null | 2 | arm 1: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval. arm 2: placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to swit... | [
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) intervention 2: None intervention 3: atomoxetine 1.2 mg/kg/day QD, PO intervention 4: atomoxetine 1.2 - 1.4 mg/kg/day QD, PO | intervention 1: atomoxetine 0.5 mg/kg/day intervention 2: placebo intervention 3: atomoxetine 1.2 mg/kg/day intervention 4: atomoxetine 1.2-1.4 mg/kg/day | 12 | Alessandria | N/A | Italy | 8.61007 | 44.90924
Bari | N/A | Italy | 16.86982 | 41.12066
Cagliari | N/A | Italy | 9.11917 | 39.23054
Genova | N/A | Italy | 11.87211 | 45.21604
Messina | N/A | Italy | 15.55256 | 38.19394
Napoli | N/A | Italy | 14.5195 | 40.87618
Padua | N/A | Italy | 11.88586 | 45.40797
Pavia | N/A | Ita... | 0 | NCT00192023 | |
[
3
] | 60 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer. | Upon determination of eligibility, all patients will be receive:
* Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab
Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 2... | Lung Cancer | null | 1 | arm 1: Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restagi... | [
0
] | 4 | [
0,
0,
0,
4
] | intervention 1: 50mg/m2 days 1 \& 8 each 21-day cycle 1 \& 2, 28-day cycle 3 \& 4 intervention 2: AUC 5 intervention 3: 10mg/kg IV every 2 weeks for 10 doses starting week 16 intervention 4: None | intervention 1: Irinotecan intervention 2: Carboplatin intervention 3: Bevacizumab intervention 4: Radiation | 0 | null | 0 | NCT00193375 | |
[
5
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study uses a computerized method of musical instrument digital interface (MIDI) quantification of performance before and after treatment with botulinum toxin type B (Myobloc ®, Solstice Neurosciences). Myobloc is a purified and diluted form of botulinum toxin used medically to relax unwanted muscle spasms and move... | Dystonia represents a group of clinical disorders characterized by various combinations of sustained involuntary muscle contractions, abnormal postures and movements, tremors and pain. Dystonia can occur at rest but is more likely to appear during voluntary activity.
Focal dystonia affects one body area and includes b... | Focal Dystonia | Myloboc Botulinum Toxin Type B Focal Dystonia Musicians Muscle Relaxants Motor Impairments Motor Performance Tremor Abnormal Postures | null | 1 | arm 1: Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation. | [
0
] | 1 | [
0
] | intervention 1: Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation. | intervention 1: Botulinum toxin, type B | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00208091 |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | African-Americans suffer from increased prevalence of both type 2 diabetes and diabetes complications, reflecting a combination of psychobehavioral factors as well as metabolic dysfunction. In this process, depression may contribute to both the genesis of type 2 diabetes (through impact on neurohormonal activation, inf... | To determine the psychobehavioral and neurohormonal mechanisms of effective treatment, the investigator will conduct a randomized, double-blind, placebo-controlled trial in patients with major depression, who will receive either: (i) computer-based cognitive behavioral therapy (CBT) program entitled "Beating the Blues"... | Diabetes Depression | null | 2 | arm 1: Subjects with type 2 diabetes will be randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months arm 2: Subjects with type 2 diabetes will be randomized to Be... | [
0,
1
] | 3 | [
5,
0,
0
] | intervention 1: Beating the Blues is a computerized cognitive behavioral therapy. intervention 2: Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months. intervention 3: A sugar pill taken as one to two tablets daily for 6 months. | intervention 1: Beating the Blues intervention 2: Escitalopram intervention 3: Placebo | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00209170 | |
[
3
] | 22 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Preoperative induction chemotherapy has been successfully used in a variety of malignancies and provides several advantages over postoperative therapy. Combination of 5-FU/Leucovorin/CPT-11 has demonstrated significantly better response rate than 5-FU/Leucovorin alone. Replacing 5-FU with oral capecitabine in combinati... | OUTLINE: This is a multi-center study.
Biopsy per EUS
* Irinotecan 200 mg/m2 IV, day 1
* Capecitabine 1000\* mg/m2 PO BID day 1-14 Repeat every three weeks for two cycles\* For calculated creatinine clearance of 30-50 mL/min or patients \> 70years old, capecitabine starting dose is 825 mg/m2 PO BID
Beginning at week... | Rectal Cancer | Rectal Cancer | null | 1 | arm 1: * Irinotecan 200 mg/m2 IV, day 1
* Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
* For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid
* EUS
* Neoadjuvant Chemotherapy
* Preoperative Radiation
* Su... | [
0
] | 7 | [
0,
0,
3,
0,
3,
3,
3
] | intervention 1: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles
\*For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid intervention 2: Irinotecan 200 mg/m2 IV, day 1 intervention 3: biopsy per EUS intervention... | intervention 1: Capecitabine intervention 2: Irinotecan intervention 3: EUS intervention 4: Neoadjuvant Chemotherapy intervention 5: Preoperative Radiation intervention 6: Surgery intervention 7: Adjuvant Chemotherapy | 9 | Elkhart | Indiana | United States | -85.97667 | 41.68199
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Goshen | Indiana | United States | -85.83444 | 41.58227
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Muncie | Indiana | Unite... | 0 | NCT00216086 |
[
5
] | 24 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury. | The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two ... | Detrusor Hyperreflexia | null | 1 | arm 1: Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing | [
0
] | 1 | [
0
] | intervention 1: 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration | intervention 1: Oxybutynin transdermal system | 6 | Atlanta | Georgia | United States | -84.38798 | 33.749
The Bronx | New York | United States | -73.86641 | 40.84985
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | ... | 0 | NCT00224029 | |
[
3
] | 27 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia. | Melatonin is a hormone secreted predominantly during the sleep period, suspected to have a strong link to the circadian sleep-wake cycle. Melatonin is also available in a pill form and, when administered during the day, tends to have a sedative effect. Clinical trials that have examined the nocturnal effects of melaton... | Sleep Initiation and Maintenance Disorders | Aged Sleep Insomnia Melatonin Neurobehavioral Manifestations Circadian Rhythms Human Polysomnography Elderly | null | 3 | arm 1: Melatonin 0.4 mg arm 2: Melatonin 4.0 mg arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None | intervention 1: Melatonin 0.4 mg intervention 2: Melatonin 4.0 mg intervention 3: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00230737 |
[
5
] | 43 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 4QUADRUPLE | true | 0ALL | false | The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment... | We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be r... | Healthy | Naltrexone Alcohol | null | 4 | arm 1: alcohol and active naltrexone arm 2: "sham" alcohol and active naltrexone arm 3: placebo naltrexone and alcohol arm 4: placebo naltrexone and placebo (non-alcoholic) alcohol | [
0,
1,
2,
2
] | 4 | [
0,
0,
10,
10
] | intervention 1: 50 mg/day for two days prior to the alcohol challenge session intervention 2: placebo pills intervention 3: 190 proof alcohol prepared to 11% volume mixed with fruit juice. intervention 4: non-alcoholic placebo alcohol | intervention 1: Naltrexone intervention 2: placebo intervention 3: alcohol intervention 4: Sham alcohol | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00256451 |
[
2,
3
] | 17 | RANDOMIZED | PARALLEL | 9OTHER | 4QUADRUPLE | false | 0ALL | false | Data supports diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway and that chronic inflammation leads to insulin resistance and diabetes. In rodents, salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is true in people. | Please see the following review articles on this topic:
Shoelson SE, Lee J, Goldfine AB. (2006) Inflammation in insulin resistance. J. Clin. Invest. 116, 1793-1801.
Goldfine AB, Fonseca V and Shoelson SE (2010) Therapeutic approaches to target inflammation in type 2 diabetes. Clin Chem. 57, 162-167.
Donath MY and Sh... | Insulin Resistance | null | 2 | arm 1: This third small study has a randomized, masked, placebo controlled parallel design to compare salsalate 4.0 g/d to placebo. This is the salsalate 4.0 g/d arm. arm 2: This third small study has a randomized, masked, placebo controlled parallel design to compare salsalate 4.0 g/d to placebo. This is the placebo a... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Active intervention 2: Placebo for salslate, used only in the third trial | intervention 1: Salsalate intervention 2: Placebo | 0 | null | 0 | NCT00258128 | |
[
0
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or bet... | At the shock trauma center, the management of patients with NSTI is conducted in the following fashion: All new patients with NSTI are admitted to the trauma center through the 12-bed shock trauma admitting area. Full hemodynamic resuscitation is undertaken. The on-call soft-tissue and infection team is mobilized. Stan... | Fasciitis, Necrotizing Severe Necrotizing Skin and Soft Tissue Infections Fournier's Gangrene | severe skin infections | null | 1 | arm 1: It was a single arm study with higher dose of daptomycin used for patients with severe skin and soft tissue infections. | [
5
] | 1 | [
0
] | intervention 1: None | intervention 1: Daptomycin 6mg/kg/day | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00261807 |
[
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib tog... | OBJECTIVES:
Primary
* Determine the overall response rate (partial and complete response) in patients with relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine hydrochloride.
Secondary
* Determine the safety and toxic effects of this regimen in these patients.
* Determine the time to pr... | Lymphoma | recurrent adult Hodgkin lymphoma | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: bortezomib intervention 2: gemcitabine hydrochloride | 2 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT00262860 |
[
3
] | 130 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer. | null | Pancreatic Neoplasm | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles intervention 2: 1000 milligrams/square meter (mg/m\^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles | intervention 1: enzastaurin intervention 2: gemcitabine | 1 | Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00267020 | |
[
3
] | 74 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | false | This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-an... | Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies)... | Sleep Apnea, Obstructive Tonsillectomy Adenoidectomy Postoperative Complications | Obstructive Sleep Apnea (OSA) Tonsillectomy and Adenoidectomy (T&A) Postoperative Complications Recovery | null | 2 | arm 1: Saline arm 2: Caffeine benzoate | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base. intervention 2: Children in group two will receive an amount of normal saline equal to Caffeine | intervention 1: Caffeine intervention 2: Placebo | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00273754 |
[
4
] | 61 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug. | Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort w... | Parkinson Disease | PD Parkinson's | null | 3 | arm 1: Conversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex. arm 2: Conversion factor of Mirapex to Requip 24-Hour o... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Requip 24-Hour once a day for one month intervention 2: All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5. | intervention 1: Requip PR intervention 2: Mirapex | 1 | Kansas City | Kansas | United States | -94.62746 | 39.11417 | 0 | NCT00275275 |
[
3
] | 10 | NON_RANDOMIZED | null | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying ho... | OBJECTIVES:
Primary
* Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
* Determine the overall and failure-free survival of patients treated with the chemotherapy regimen.
* Determine t... | Colorectal Cancer | adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer | null | 0 | null | null | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: gemcitabine hydrochloride intervention 2: oxaliplatin | 1 | Miami | Florida | United States | -80.19366 | 25.77427 | 0 | NCT00276861 |
[
4
] | 849 | RANDOMIZED | SINGLE_GROUP | 1PREVENTION | 2DOUBLE | false | 0ALL | true | Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compar... | This is a prospective, randomized, multicenter clinical trial. All adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate. | Postoperative Wound Infection | Prevention Antiseptic Preoperative Scrub Postoperative Wound Infection | null | 2 | arm 1: preoperative skin preparation with povidone-iodine arm 2: preoperative skin preparation with scrub and paint technique | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Preoperative skin preparation with scrub and paint technique intervention 2: preoperative skin preparation with scrub and paint technique | intervention 1: chlorhexidine-alcohol intervention 2: Povidone-Iodine | 6 | West Roxbury | Massachusetts | United States | -71.1495 | 42.27926
Durham | North Carolina | United States | -78.89862 | 35.99403
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Milwaukee | Wisconsi... | 0 | NCT00290290 |
[
4
] | 190 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding. | This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial. | Metrorrhagia | Dysfunctional Uterine Bleeding | null | 2 | arm 1: A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo arm 2: Matching placebo to be taken orally daily | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle) intervention 2: Matching placebo to be taken orally daily. | intervention 1: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Placebo | 46 | Lake Havasu City | Arizona | United States | -114.32245 | 34.4839
Greenbrae | California | United States | -122.5247 | 37.94854
Los Angeles | California | United States | -118.24368 | 34.05223
Pacific Palisades | California | United States | -118.52647 | 34.04806
San Diego | California | United States | -117.16472 | 32... | 0 | NCT00293059 |
[
4
] | 7 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | true | D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.
This randomized, double-blind, placebo-controlled clinical trial was designed to st... | This is a randomized, double-blind, placebo-controlled study. Initially, patients were randomized to 1 of 2 treatment arms (D-cycloserine 250 mg twice daily or placebo twice daily), and treated for up to 4 weeks in the absence of unacceptable toxicity.
Later, the design was changed to randomize patients to 1 of 3 arms... | Neurotoxicity Pain Breast Cancer | pain neurotoxicity breast cancer | null | 5 | arm 1: Placebo administered orally twice per day for 4 weeks. arm 2: D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks. arm 3: D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks. arm 4: This was the original active comparator arm (before the design was changed... | [
2,
1,
1,
1,
2
] | 2 | [
0,
10
] | intervention 1: None intervention 2: None | intervention 1: D-cycloserine intervention 2: Placebo | 2 | Chicago | Illinois | United States | -87.65005 | 41.85003
Madison | Wisconsin | United States | -89.40123 | 43.07305 | 0 | NCT00301080 |
[
3
] | 72 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim. | null | Thrombocytopenia MDS Myelodysplastic Syndromes Refractory Cytopenias | MDS Myelodysplastic Syndromes Refractory Cytopenias Thrombocytopenia | null | 7 | arm 1: Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 2: Cohort 2 in Part A, participants received romiplostim 700 µg ... | [
0,
0,
0,
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Romiplostim | 0 | null | 0 | NCT00303472 |
[
3
] | 200 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The aim of this study was to determine whether long-term (≥ 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%. | null | Diastolic Heart Failure | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period ... | intervention 1: Sitexsentin sodium intervention 2: Placebo | 52 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Mobile | Alabama | United States | -88.04305 | 30.69436
Little Rock | Alaska | United States | N/A | N/A
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.9... | 0 | NCT00303498 | |
[
4
] | 231 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding. | 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. | Metrorrhagia | Dysfunctional uterine bleeding | null | 2 | arm 1: A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo. arm 2: Matching placebo to be taken orally daily. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 1 pill per day taken orally over 7 cycles of 28 pills per cycle intervention 2: 1 pill per day taken orally over 7 cycles of 28 pills per cycle | intervention 1: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Placebo | 36 | Ashfield | New South Wales | Australia | 151.12274 | -33.88834
Subiaco | Western Australia | Australia | 115.8268 | -31.9485
České Budějovice | N/A | Czechia | 14.47434 | 48.97447
Pardubice | N/A | Czechia | 15.77659 | 50.04075
Písek | N/A | Czechia | 14.1475 | 49.3088
Prague | N/A | Czechia | 14.42076 | 50.08804
Espoo... | 0 | NCT00307801 |
[
2
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x... | OBJECTIVES:
Primary
* Determine the maximum tolerated dose of pemetrexed disodium when given in combination with upper abdominal radiotherapy after induction therapy comprising gemcitabine hydrochloride and pemetrexed disodium followed by consolidation therapy with gemcitabine hydrochloride in patients with locally a... | Pancreatic Cancer | stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer | null | 1 | arm 1: Patients will receive Pemetrexed plus Radiotherapy. | [
0
] | 2 | [
0,
1
] | intervention 1: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy). intervention 2: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and co... | intervention 1: pemetrexed disodium intervention 2: Radiotherapy | 1 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 | 0 | NCT00310050 |
[
3
] | 1,741 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack. | null | Acute Coronary Syndrome (ACS) | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
1,
0,
2,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: Tablets, Oral, 2.5 mg, twice daily, 26 weeks intervention 2: Tablets, Oral, 10 mg, once daily, 26 weeks intervention 3: Tablets, Oral, 0, twice daily, 26 weeks intervention 4: Tablets, Oral 10 mg, twice daily, 26 weeks | intervention 1: Apixaban intervention 2: Apixaban intervention 3: Placebo intervention 4: Apixaban | 151 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Los Angeles | California | United States | -118.24368 | 34.05223
Santa Rosa | California | United States | -122.71443 | 38.44047
Littleton | Colorado | United States | -105.01665 | 39.61332
Lakeland | Florida | United States | -81.9498 | 28.03947
Safety Harbo... | 0 | NCT00313300 | |
[
4
] | 240 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs). | null | Partial Seizures | Epilepsy Partial seizures | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period a... | intervention 1: Zonisamide intervention 2: Placebo | 8 | Beijing | Beijing Municipality | China | 116.39723 | 39.9075
Beijing | Beijing Municipality | China | 116.39723 | 39.9075
Beijing | Beijing Municipality | China | 116.39723 | 39.9075
Chongqing | Chongqing Municipality | China | 106.55771 | 29.56026
Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222
Shangha... | 0 | NCT00327717 |
[
5
] | 142 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | We propose to test whether intraoperative administration of dexmedetomidine will reduce hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic requirements in patients undergoing carotid endarterectomy. | Remifentanil is an amidopiperidine derivative with unique pharmacokinetic properties. Its steady-state volume of distribution is 30 L (3). Its context-sensitive half life is consistently short (3.2 min), even after prolonged infusion(4). The pharmacokinetic profile of remifentanil is independent of the hepatic (5) and ... | Carotid Artery Stenosis | Carotid Endarterectomy patients | null | 2 | arm 1: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical arm 2: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the en... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical intervention 2: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/... | intervention 1: Remifentanil intervention 2: Dexmedetomidine | 1 | Cleveland | Ohio | United States | -81.69541 | 41.4995 | 0 | NCT00335972 |
[
4
] | 843 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment. | null | Chronic Obstructive Pulmonary Disease (COPD) | COPD Lung function Exacerbations Quality of Life | null | 2 | arm 1: Aclidinium bromide 200 μg once-daily by inhalation arm 2: Placebo once-daily via inhalation | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks intervention 2: Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks | intervention 1: Aclidinium bromide intervention 2: Placebo | 132 | Les Escaldes | N/A | Andorra | 1.53414 | 42.50729
Graz | N/A | Austria | 15.45 | 47.06667
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Linz | N/A | Austria | 14.28611 | 48.30639
Vienna | N/A | Austria | 16.37208 | 48.20849
Vienna | N/A | Austria | 16.37208 | 48.20849
Aalst | N/A | Belgium | 4.0355 | 50.93604
Brussel... | 0 | NCT00363896 |
[
4
] | 568 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg ... | Please see brief summary. | TOBACCO USE CESSATION | null | 2 | arm 1: Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions. arm 2: Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 8-weeks of nicotine patch + 16-weeks of placebo intervention 2: 24-weeks of 21mg nicotine patch | intervention 1: Standard Patch Treatment intervention 2: 24-weeks of nicotine patch | 2 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00364156 | |
[
2,
3
] | 12 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and meth... | The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with ... | Psoriasis | null | 4 | arm 1: Monotherapy with Raptiva alone arm 2: Combination therapy with both Raptiva and Methotrexate arm 3: Continue Raptiva, discontinue methotrexate arm 4: Continue combination therapy with both Raptiva and Methotrexate | [
1,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Initial dose 5 mg, then 15 mg per week intervention 2: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg | intervention 1: Methotrexate intervention 2: Raptiva | 1 | Sacramento | California | United States | -121.4944 | 38.58157 | 0 | NCT00368654 | |
[
4
] | 196 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | true | The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia. | null | Menorrhagia Heavy Menstrual Bleeding | Heavy Menstrual Bleeding Menorrhagia | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 3900 mg/Day intervention 2: None | intervention 1: Tranexamic acid tablets intervention 2: Placebo tablets | 52 | Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Carmichael | California | United States | -121.32828 | 38.61713
San Diego | California | United States | -117.16472 | 32.71571
Upland | Californ... | 0 | NCT00386308 |
[
4
] | 400 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in... | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: Liraglutide 0.9 mg + glibenclamide placebo arm 2: Glibenclamide 1.25-2.5 mg + liraglutide placebo | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 0.9 mg/day. Injected s.c. (under the skin) once daily. intervention 2: 1.25-2.5 mg tablet. Given orally once or twice daily. intervention 3: liraglutide placebo. Injected s.c. (under the skin) once daily. intervention 4: glibenclamide placebo. Given orally once or twice daily. | intervention 1: liraglutide intervention 2: glibenclamide intervention 3: placebo intervention 4: placebo | 1 | Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00393718 | |
[
4
] | 264 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combin... | null | Diabetes Diabetes Mellitus, Type 2 | null | 4 | arm 1: Liraglutide 0.6 mg + sulphonylurea arm 2: Liraglutide 0.9 mg + sulphonylurea arm 3: Liraglutide placebo 0.6 mg + sulphonylurea arm 4: Liraglutide placebo 0.9 mg + sulphonylurea | [
0,
0,
2,
2
] | 3 | [
0,
0,
0
] | intervention 1: SU agent intervention 2: Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily. intervention 3: Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily. | intervention 1: sulfonylurea intervention 2: liraglutide intervention 3: liraglutide | 1 | Tokyo | N/A | Japan | 139.69171 | 35.6895 | 0 | NCT00395746 | |
[
4
] | 304 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | true | The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia. | null | Menorrhagia Heavy Menstrual Bleeding | Menorrhagia Heavy Menstrual Bleeding | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 3900 mg/Day intervention 2: 1950 mg/Day intervention 3: None | intervention 1: Tranexamic acid tablets intervention 2: Tranexamic acid tablets intervention 3: Placebo tablets | 83 | 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
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Searcy | Arkansas | United... | 0 | NCT00401193 |
[
5
] | 477 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | null | This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or cap... | null | Influenza | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks. intervention 2: Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks. | intervention 1: Oseltamivir intervention 2: Placebo | 78 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Stanford | California | United States | -122.16608 | 37.42411
Denver | Colorado | United States | -104.9847 | 39.73915
Hartford | Connecticut | United States | -72.68509 | 41.76371
Newark | Delaware... | 0 | NCT00412737 | |
[
3
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer. | Despite a modest improvement in survival with available chemotherapy treatments, androgen-independent metastatic prostate cancer remains essentially incurable.
Several changes in gene function that characterize malignancy have been identified. For example the p53 gene in normal tissue lessens the risk of cancer throug... | Prostatic Cancer | Cancer of Prostate Prostate Cancer Cancer of the Prostate Neoplasms, Prostate Neoplasms, Prostatic Prostate Neoplasms Prostatic Cancer Androgen-Independent Prostate Cancer | null | 1 | arm 1: Uncontrolled treatment arm | [
0
] | 1 | [
0
] | intervention 1: 100 mg daily | intervention 1: Quinacrine | 0 | null | 0 | NCT00417274 |
[
4
] | 1,272 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia. | This is a multi-centre, comparative, randomised, (double-blind, double-dummy), parallel-group, non-inferiority study comparing the efficacy and safety of the fixed combination of PA with that of AL in the treatment of acute, uncomplicated P. falciparum malaria. The study population will include 1269 patients, comprisin... | Malaria | malaria antimalarial artemisinin based combination therapy (ACT) P. falciparum pyronaridine artesunate (Pyramax) | null | 2 | arm 1: Pyronaridine artesunate (PA) arm 2: Arthemether lumefantrine (AL) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2) intervention 2: AL (20:120mg tablets) twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2) | intervention 1: Pyronaridine artesunate intervention 2: Coartem® (artemether lumefantrine) | 10 | Kinshasa | N/A | Democratic Republic of the Congo | 15.31357 | -4.32758
Kumasi | N/A | Ghana | -1.62443 | 6.68848
Maumere | Nusa Tenggara Timur | Indonesia | 122.2111 | -8.6199
Jayapura | Special Region of Papua | Indonesia | 140.71813 | -2.53371
Siaya | N/A | Kenya | 34.28806 | 0.0607
Bamako | N/A | Mali | -7.97522 | ... | 0 | NCT00422084 |
[
3
] | 19 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Primary Objectives:
1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer.
2. To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant and long-term progr... | If tumors shrink by standard-dose chemotherapy, patients will receive moderate dose chemotherapy to prepare for the blood stem cell transplant. The drug fludarabine will be given by vein on days 1-5. The drug melphalan will be given by vein on days 4 and 5. Day 6 will be a rest day; no drugs will be given. The blood st... | Breast Cancer | Breast Cancer PBPC Transplantation Stem Cell Infusion Fludarabine Melphalan | null | 1 | arm 1: Intravenous Fludarabine 30 mg/m\^2 daily on days 1-5, and Melphalan 70 mg/m\^2 on days 4 and 5 followed by blood stem cell transplant on day 7. | [
0
] | 3 | [
0,
0,
3
] | intervention 1: 30 mg/m\^2 intravenously Daily for 5 Days intervention 2: 70 mg/m\^2 intravenously Daily for 2 Days intervention 3: Stem Cell Infusion on Day 0. | intervention 1: Fludarabine intervention 2: Melphalan intervention 3: Stem Cell Infusion | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00429572 |
[
4
] | 148 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. ... | null | Post-stroke Upper Limb Spasticity | null | 2 | arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution,... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of ... | intervention 1: IncobotulinumtoxinA (Xeomin) intervention 2: Placebo | 3 | Czech Republic | N/A | Czechia | N/A | N/A
Hungary | N/A | Hungary | N/A | N/A
Poland | N/A | Poland | N/A | N/A | 0 | NCT00432666 | |
[
3
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer. | null | Metastatic Breast Cancer | Avastin MBC Breast Cancer Sutent | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Intravenous repeating dose intervention 2: Oral repeating dose intervention 3: Intravenous repeating dose | intervention 1: bevacizumab intervention 2: sunitinib intervention 3: paclitaxel | 0 | null | 0 | NCT00434356 |
[
5
] | 10 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | null | 0ALL | null | The study will evaluate kidney graft function in maintenance renal transplant patients. | null | Kidney Transplantation | Kidney Transplantation Mycophenolic Acid Immunosuppression Cyclosporine | null | 2 | arm 1: The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mo... | [
0,
1
] | 1 | [
0
] | intervention 1: None | intervention 1: Enteric coated mycophenolate sodium (Myfortic®) | 1 | Bologna | N/A | Italy | 11.33875 | 44.49381 | 0 | NCT00434590 |
[
4
] | 1,004 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic BP in hypertensive patients after 8 weeks of double-blind treatment.
The study consisted of two sequential phases of 8 weeks duration e... | Methodology:
After the signature of the informed consent, patients were screened for eligibility and eligible patients entered into a pre-randomisation period consisting of a taper-off phase of approximately 1-2 weeks (during which patients treated for hypertension were to discontinue their antihypertensive therapy) f... | Hypertension | null | 2 | arm 1: Olmesartanmedoxomil (OM)40 mg tablets. arm 2: Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets. | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks. intervention 2: Initially patients were to be treated wit... | intervention 1: OM 40 intervention 2: OM/HCTZ 40/12.5 | 65 | Rijeka | N/A | Croatia | 14.44241 | 45.32673
Slavonski Brod | N/A | Croatia | 18.01556 | 45.16028
Split | N/A | Croatia | 16.43915 | 43.50891
Varaždin | N/A | Croatia | 16.33778 | 46.30444
Zadar | N/A | Croatia | 15.22514 | 44.11578
Zagreb | N/A | Croatia | 15.97798 | 45.81444
Benátky nad Jizerou | N/A | Czechia | 14.8... | 0 | NCT00441350 | |
[
3
] | 57 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of participants, who will receive ascending doses of ... | Male or female, 4 to 24 months of age (inclusive) with a diagnosis of IS with a 24 hour video EEG (vEEG) recording confirming the diagnosis and previously treated with 3 or fewer antiepileptic drugs (AEDs) are eligible for the study. The subject is able to continue treatment with concomitant AEDs (no more than 2; adren... | Infantile Spasms | infantile spasms anticonvulsant pediatric epilepsy West Syndrome epileptic spasms | null | 2 | arm 1: ganaxolone arm 2: placebo | [
0,
2
] | 2 | [
0,
10
] | intervention 1: None intervention 2: None | intervention 1: Ganaxolone intervention 2: Placebo | 15 | Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Miami | Florida | United States | -80.19366 | 25.77427
Pensacola | Florida | United States | -87.21691 | 30.4213... | 0 | NCT00441896 |
[
4
] | 460 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID) | null | Pelvic Inflammatory Disease | Uncomplicated pelvic inflammatory disease | null | 2 | arm 1: Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days arm 2: Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days intervention 2: Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days | intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Levofloxacin & Metronidazole | 13 | Shenyang | Liaoning | China | 123.43278 | 41.79222
Chengdu | Sichuan | China | 104.06667 | 30.66667
Beijing | N/A | China | 116.39723 | 39.9075
Beijing | N/A | China | 116.39723 | 39.9075
Chongqing | N/A | China | 106.55771 | 29.56026
Shanghai | N/A | China | 121.45806 | 31.22222
Jakarta | N/A | Indonesia | 106.84513 |... | 0 | NCT00453349 |
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