FEATURE_phases list | FEATURE_enrollmentCount int64 | FEATURE_allocation string | FEATURE_interventionModel string | FEATURE_primaryPurpose class label | FEATURE_masking class label | FEATURE_healthyVolunteers bool | FEATURE_sex class label | FEATURE_oversightHasDmc bool | FEATURE_briefSummary string | FEATURE_detailedDescription string | FEATURE_conditions string | FEATURE_conditionsKeywords string | FEATURE_protocolPdfText string | FEATURE_numArms int64 | FEATURE_armDescriptions string | FEATURE_armGroupTypes list | FEATURE_numInterventions int64 | FEATURE_interventionTypes list | FEATURE_interventionDescriptions string | FEATURE_interventionNames string | FEATURE_numLocations int64 | FEATURE_locationDetails string | LABEL_ct_level_ade_population int64 | LABEL_sum_dosing_errors int64 | LABEL_dosing_error_rate float32 | LABEL_wilson_label int64 | METADATA_nctId string | METADATA_overallStatus class label | METADATA_completionDate date32 | METADATA_startDate date32 | METADATA_leadSponsorName string | METADATA_leadSponsorClass class label | METADATA_hasProtocol bool | METADATA_hasSap bool | METADATA_hasIcf bool | METADATA_protocolPdfLinks string | METADATA_count_Accidental drug intake by child int64 | METADATA_count_Accidental overdose int64 | METADATA_count_Accidental overdose (therapeutic agent) int64 | METADATA_count_Accidental underdose int64 | METADATA_count_Deliberate overdose int64 | METADATA_count_Dose calculation error int64 | METADATA_count_Drug administration error int64 | METADATA_count_Drug overdose int64 | METADATA_count_Drug overdose accidental int64 | METADATA_count_Extra dose administered int64 | METADATA_count_Incorrect dosage administered int64 | METADATA_count_Incorrect dose administered int64 | METADATA_count_Incorrect drug administration duration int64 | METADATA_count_Incorrect drug administration rate int64 | METADATA_count_Incorrect product administration duration int64 | METADATA_count_Intentional overdose int64 | METADATA_count_Medication error int64 | METADATA_count_Medication monitoring error int64 | METADATA_count_Multiple drug overdose int64 | METADATA_count_Multiple drug overdose accidental int64 | METADATA_count_Multiple drug overdose intentional int64 | METADATA_count_Multiple use of single-use product int64 | METADATA_count_Non-accidental overdose int64 | METADATA_count_Overdose int64 | METADATA_count_Overdose NOS int64 | METADATA_count_Overmedication int64 | METADATA_count_Prescribed overdose int64 | METADATA_count_Treatment noncompliance int64 | METADATA_count_Underdose int64 | METADATA_count_Unintentional medical device removal int64 | METADATA_count_Unintentional medical device removal by patient int64 | METADATA_wilson_lower_bound float32 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
3
] | 74 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be acc... | null | Carcinoma, Renal Cell | c-Met Papillary Renal Cell Carcinoma(PRC) Sporadic papillary renal cell carcinoma, Clear cell renal carcinoma Hereditary papillary renal cell carcinoma, | null | 2 | arm 1: 240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days. arm 2: 80 mg foretinib on a daily dosing regimen | [
0,
0
] | 1 | [
0
] | intervention 1: treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule | intervention 1: foretinib (formerly GSK1363089 or XL880) | 12 | Greenbrae | California | United States | -122.5247 | 37.94854
San Francisco | California | United States | -122.41942 | 37.77493
Stanford | California | United States | -122.16608 | 37.42411
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Bethesda | Maryland | United States | -77.10026 | 38.98067
Boston |... | 74 | 0 | 0 | 0 | NCT00726323 | 1COMPLETED | 2010-08-18 | 2006-06-30 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 1FEMALE | null | The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low bone mass. | null | Osteopenia | Amgen Postmenopausal Bone Density | null | 2 | arm 1: Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. arm 2: Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection | intervention 1: Romosozumab intervention 2: Placebo | 0 | null | 24 | 0 | 0 | 0 | NCT00950950 | 1COMPLETED | 2010-08-19 | 2009-08-18 | Amgen | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 7 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202. | null | Crohn's Disease Inflammatory Bowel Disease | Crohn's Disease Crohns Bowel disease digestive disorders auto immune diarrhea Inflammatory Bowel Disease (IBD) gastrointestinal diseases digestive system diseases Antibody IL 17 anti IL-17 monoclonal antibody Crohn's Disease (Chron's, CD) | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: AIN457 | 5 | Bristol | Connecticut | United States | -72.94927 | 41.67176
Great Neck | New York | United States | -73.72846 | 40.80066
New York | New York | United States | -74.00597 | 40.71427
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Raleigh | North Carolina | United States | -78.63861 | 35.7721 | 7 | 0 | 0 | 0 | NCT01009281 | 6TERMINATED | 2010-08-19 | 2009-10-30 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 65 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer. | Primary Objective:
\- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks.
Secondary Objectives:
* To evaluate the efficacy of CS-1008 administered in comb... | Pancreatic Cancer | Pancreatic cancer chemotherapy naive unresectable or metastatic pancreatic cancer CS1008 Gemcitabine Gemzar | null | 1 | arm 1: CS-1008 + gemcitabine | [
0
] | 2 | [
0,
0
] | intervention 1: CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly. intervention 2: Gemcitabine - 1000mg/meter sq | intervention 1: CS-1008 (humanized anti-DR5 antibody) intervention 2: gemcitabine | 12 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Fort Myers | Florida | United States | -81.84059 | 26.62168
Atlanta | Georgia | United States | -84.38798 | 33.749
Tucker | Georgia | United States | -84.21714 | 33.85455
Decatur | I... | 62 | 0 | 0 | 0 | NCT00521404 | 1COMPLETED | 2010-08-20 | 2007-08-15 | Daiichi Sankyo | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 128 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockad... | null | Neuromuscular Blockade | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion intervention 2: neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast ... | intervention 1: sugammadex intervention 2: neostigmine | 0 | null | 120 | 0 | 0 | 0 | NCT01050543 | 1COMPLETED | 2010-08-20 | 2010-02-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 72 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | true | A primary objective of this study is to evaluate the in vivo response of tumor to chemotherapy through gene microarray analysis. Neoadjuvant treatment allows the unique opportunity to observe the in vivo effects of cytotoxic therapy on gene expression in tumor tissue. The investigators plan to evaluate several differen... | The clinical outcomes of breast cancer treatment are remarkably similar regardless of the regimen used, even though the individual drugs may differ substantially in mechanisms of action. We are interested in identifying a set of genes that may be associated with breast cancer cell survival following selection by chemot... | Malignant Neoplasm of Female Breast | Malignant Neoplasm Cancer Female Breast Stage II Stage III | null | 2 | arm 1: Arm A: Epirubicin 90 mg/m2 day 1 IV and Cyclophosphamide 600 mg/m2 day 1 IV q 3 weeks for 4 cycles, then surgery, then Docetaxel 75 mg/m2 IV day 1 plus Capecitabine 1000 mg/m2/dose po bid x 14 days q 3 weeks for 4 cycles, then radiation therapy as indicated. Post surgical chemotherapy must be initiated within 35... | [
1,
1
] | 5 | [
0,
0,
0,
0,
4
] | intervention 1: Epirubicin 90 mg/m2 d1 q3w intervention 2: Cyclophosphamide 600 mg/m2 d1 q3w intervention 3: Docetaxel 75 mg/m2 d1 q3w intervention 4: Capecitabine 1000 mg/m2/dose bid x 14d q3w intervention 5: Standard dosing, fields depending on clinical findings | intervention 1: Epirubicin intervention 2: Cyclophosphamide intervention 3: Docetaxel intervention 4: Capecitabine intervention 5: Radiation Therapy | 1 | Aurora | Colorado | United States | -104.83192 | 39.72943 | 72 | 0 | 0 | 0 | NCT01869192 | 1COMPLETED | 2010-08-21 | 2003-03-05 | University of Colorado, Denver | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 1 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | RATIONALE: Dehydroepiandrosterone (DHEA) may slow the growth of tumor cells and be an effective treatment for women with breast cancer.
PURPOSE: This phase I trial is studying how well DHEA works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer. | OBJECTIVES:
Primary
* To identify the effect of the adrenal steroid, dehydroepiandrosterone (DHEA), on tumor proliferation in women with estrogen receptor-negative, progesterone receptor-negative, HER2/neu-negative, and androgen receptor (AR)-positive stage I-III adenocarcinoma of the breast.
Secondary
* To study t... | Breast Cancer | triple-negative breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer | null | 1 | arm 1: Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery; | [
0
] | 2 | [
0,
3
] | intervention 1: DHEA administration will begin approxiately 14 days prior to surgery. intervention 2: Surgical procedure of the invasive breast cancer | intervention 1: DHEA intervention 2: Surgical resection | 1 | Detroit | Michigan | United States | -83.04575 | 42.33143 | 1 | 0 | 0 | 0 | NCT00972023 | 6TERMINATED | 2010-08-22 | 2010-02-01 | Barbara Ann Karmanos Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 447 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes. | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Injected s.c. (under the skin) with the breakfast meal and main evening meal. The dose were individually adjusted. Subjects continued their pre-trial OADs (oral antidiabetic drug(s)) treatment of Metformin, the specific DPP-4 Inhibitor and Pioglitazone. intervention 2: Injected s.c. (under the skin) wit... | intervention 1: insulin degludec/insulin aspart intervention 2: biphasic insulin aspart 30 | 53 | St Leonards | New South Wales | Australia | 151.19836 | -33.82344
Wollongong | New South Wales | Australia | 150.89345 | -34.424
East Ringwood | Victoria | Australia | N/A | N/A
Melbourne | Victoria | Australia | 144.96332 | -37.814
Garran | N/A | Australia | 149.10846 | -35.34206
Århus C | N/A | Denmark | N/A | N/A
Co... | 446 | 1 | 0.002242 | 1 | NCT01009580 | 1COMPLETED | 2010-08-23 | 2009-11-05 | Novo Nordisk A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000396 | |
[
3
] | 181 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | The purpose of this study is to compare the incidence of cardiac dysfunction in subjects with human epidermal growth factor receptor 2 (HER2) positive breast cancer treated with either doxorubicin or pegylated liposomal doxorubicin (PLD), both in combination with trastuzumab. | null | Breast Neoplasm | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: doxorubicin 60 mg/m\^2 IV push + cyclophosphamide 600 mg/m\^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m\^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4... | intervention 1: doxorubicin, cyclophosphamide, paclitaxel, trastuzumab intervention 2: PLD, cyclophosphamide, trastuzumab, paclitaxel | 0 | null | 179 | 0 | 0 | 0 | NCT00550771 | 1COMPLETED | 2010-08-23 | 2007-07-16 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 97 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia. | null | Schizophrenia | null | 1 | arm 1: Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability | [
0
] | 1 | [
0
] | intervention 1: Cariprazine was supplied in capsules. | intervention 1: Cariprazine | 65 | Costa Mesa | California | United States | -117.91867 | 33.64113
Long Beach | California | United States | -118.18923 | 33.76696
Oceanside | California | United States | -117.37948 | 33.19587
Paramount | California | United States | -118.15979 | 33.88946
Riverside | California | United States | -117.39616 | 33.95335
Was... | 93 | 1 | 0.010753 | 1 | NCT00839852 | 1COMPLETED | 2010-08-31 | 2009-05-31 | Forest Laboratories | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.001901 | |
[
3
] | 34 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving ketoconazole and hydrocortisone together with lenalidomide may be an effecti... | OBJECTIVES:
Primary
* Determine the objective response frequency in patients with hormone-refractory progressive prostate cancer treated with ketoconazole, hydrocortisone, and lenalidomide.
Secondary
* Determine the effect of this regimen on time to clinical progression in these patients.
* Determine the safety of ... | Prostate Cancer | adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer recurrent prostate cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 400 tid intervention 2: Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle. intervention 3: 20mg qam 10mg qhs | intervention 1: ketoconazole intervention 2: lenalidomide intervention 3: therapeutic hydrocortisone | 6 | Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 ... | 34 | 0 | 0 | 0 | NCT00460031 | 1COMPLETED | 2010-08-31 | 2006-09-01 | Case Comprehensive Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 832 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis. | null | Arthritis Osteoarthritis | monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
1,
2
] | 4 | [
2,
2,
0,
10
] | intervention 1: tanezumab 10 mg one dose at weeks 0 and 8 intervention 2: tanezumab 5 mg one dose at weeks 0 and 8 intervention 3: naproxen 1000 mg daily for 16 weeks intervention 4: placebo to match tanezumab and naproxen dosing | intervention 1: tanezumab 10 mg intervention 2: tanezumab 5 mg intervention 3: naproxen intervention 4: placebo | 94 | Anniston | Alabama | United States | -85.83163 | 33.65983
Anniston | Alabama | United States | -85.83163 | 33.65983
Mesa | Arizona | United States | -111.82264 | 33.42227
Paradise Valley | Arizona | United States | -111.94265 | 33.53115
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United ... | 828 | 0 | 0 | 0 | NCT00830063 | 1COMPLETED | 2010-08-31 | 2009-05-05 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 115 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | false | The objective of this study is to evaluate the efficacy and safety of recombinant human growth hormone (r-hGH) treatment in girls with Turner Syndrome under the age of 4 years. After 4 years of treatment, height in these girls will be compared with an historical control group of untreated girls with Turner Syndrome, ma... | null | Turner's Syndrome | Growth hormone Turner syndrome r-hGH early treatment | null | 2 | arm 1: Participants (girls) will receive r-hGH as a subcutaneous injection administered by a parent in the evening. During Years 1-2, the dose of r-hGH received will depend on participants' baseline height standard deviation score (SDS) relative to the general population standard: participants with a height SDS of -2 s... | [
0,
4
] | 1 | [
0
] | intervention 1: Subcutaneous administration. | intervention 1: r-hGH | 1 | Paris | N/A | France | 2.3488 | 48.85341 | 61 | 0 | 0 | 0 | NCT01066052 | 1COMPLETED | 2010-08-31 | 1992-02-29 | Merck KGaA, Darmstadt, Germany | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 7,609 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women. | null | Osteoporosis | Osteoporosis Postmenopause | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
10
] | intervention 1: BZA 20mg, daily, oral intervention 2: Placebo, daily, oral | intervention 1: Bazedoxifene Acetate intervention 2: Placebo | 375 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Huntsville | Alabama | United States | -86.58594 | 34.7304
Mobile | Alabama | United States | -88.04305 | 30.69436
Glendale | Arizona | Unit... | 7,492 | 54 | 0.007208 | 1 | NCT00205777 | 1COMPLETED | 2010-09-01 | 2001-12-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 16 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 38 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.005529 |
[
4
] | 14,269 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a... | Patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-CNS) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots). Treatment will be double-bl... | Atrial Fibrillation Stroke Embolism | Atrial Fibrillation Stroke Embolism Non-central nervous system systemic embolism Non-valvular atrial fibrillation Blood Clot Rivaroxaban Warfarin Anticoagulants Arrhythmias, Cardiac | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once ... | intervention 1: Rivaroxaban intervention 2: Warfarin intervention 3: Matching placebo for Rivaroxaban arm (Warfarin placebo) intervention 4: Matching placebo for Warfarin arm (Rivaroxaban placebo) | 932 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Dothan | Alabama | United States | -85.39049 | 31.22323
Geneva | Alabama | United States | -85.86382 | 31.03296
Mobile | Alabama | United States | -88.04305 | 30.69436
Pell City | Alabama | United States | -86.28609 | 33.58621
Glendale | Arizona | United State... | 14,236 | 7 | 0.000492 | 1 | NCT00403767 | 1COMPLETED | 2010-09-01 | 2006-12-01 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 4INDUSTRY | false | false | false | null | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000238 |
[
4
] | 209 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options. | null | Acquired Immunodeficiency Syndrome HIV Infection | Multicenter Open Label Non-Comparative Safety Study Of Maraviroc Treatment Experienced | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the p... | intervention 1: Maraviroc | 16 | Salvador | Estado de Bahia | Brazil | -38.49096 | -12.97563
Brasília | Federal District | Brazil | -47.92972 | -15.77972
Belo Horizonte | Minas Gerais | Brazil | -43.93778 | -19.92083
Curitiba | Paraná | Brazil | -49.27306 | -25.42778
Nova Iguaçu | Rio de Janeiro | Brazil | -43.45111 | -22.75917
Porto Alegre | Rio Gran... | 206 | 2 | 0.009709 | 1 | NCT00478231 | 1COMPLETED | 2010-09-01 | 2007-07-01 | ViiV Healthcare | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.002667 |
[
4
] | 191 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | true | 0ALL | true | The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo. | Chronic migraine affects about 2 percent of all adults. Currently there are no effective preventative treatments to deal with this disabling condition. Three randomized, placebo-controlled trials found that topiramate was an effective, safe and generally well-tolerated drug for treating chronic migraine. As a result of... | Chronic Migraine | chronic migraine, migraine prevention, chronic headache | null | 2 | arm 1: Participants will receive propranolol and topiramate. arm 2: Participants will receive a placebo and topiramate. | [
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: Propranolol LA up to 240 mg/day intervention 2: Topiramate is an effective, safe and generally well-tolerated drug used for treating chronic migraine. It is becoming the standard treatment among headache specialists. intervention 3: an inactive substance | intervention 1: propranolol LA intervention 2: topiramate intervention 3: placebo | 39 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Tuscon | Arizona | United States | N/A | N/A
Chico | California | United States | -121.83748 | 39.72849
Colton | California | United States | -117.31365 | 34.0739
Irvine | California | United States | -117.82311 | 33.66946
Sacramento | California | United States... | 191 | 1 | 0.005236 | 1 | NCT00772031 | 1COMPLETED | 2010-09-01 | 2008-10-01 | Anne Lindblad | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000925 |
[
4
] | 644 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD). | null | Pulmonary Disease, Chronic Obstructive | null | 3 | arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler arm 3: High dose inhaled orally once daily from the Respimat inhaler | [
0,
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: Comparison of low and high doses on efficacy and safety in COPD patients intervention 2: Comparison of low and high doses on efficacy and safety in COPD patients intervention 3: Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler | intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Placebo | 51 | Mobile | Alabama | United States | -88.04305 | 30.69436
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Waterbury | Connecticut | United States | -73.0515 | 41.55815
Clearwater | Florida | United States | -82.8001 | 27.96585
Panama City | Flori... | 642 | 1 | 0.001558 | 1 | NCT00782509 | 1COMPLETED | 2010-09-01 | 2009-02-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000275 | |
[
4
] | 369 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The primary objective of this study is to examine the efficacy of memantine on cognition and behavioural symptoms in outpatients with moderate to severe dementia of the Alzheimer's type. | Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Results from clinical trials in patients with moderate to... | Alzheimer's Disease | Alzheimer's Disease | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 20 mg Oral Tablets Once Daily intervention 2: Oral Tablets Once Daily | intervention 1: Memantine intervention 2: Placebo | 23 | Edmonton | Alberta | Canada | -113.46871 | 53.55014
Kelowna | British Columbia | Canada | -119.48568 | 49.88307
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
Saint John | New Brunswick | Canada | -66.05616 | 45.27076
Kentville | Nova Scotia | Canada | -64.49605 | 45.0771
Pictou | Nova Scotia | Canada | -62.70936 |... | 369 | 1 | 0.00271 | 1 | NCT00857649 | 6TERMINATED | 2010-09-01 | 2003-12-01 | H. Lundbeck A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000479 |
[
3
] | 100 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Participants in this study are suffering from rare and serious blood disorders. In aplastic anemia, the bone marrow stops producing red blood cells, platelets, and white blood cells. In pure red cell aplasia, the bone marrow stops producing red cells, and in amegakaryocytic thrombocytopenic purpura, the bone marrow sto... | Many bone marrow failure syndromes in humans are now recognized to result from immunological mechanisms. These diseases include aplastic anemia; single hematopoietic lineage failures such as pure red cell aplasia, Diamond Blackfan Anemia, agranulocytosis, and amegakaryocytic thrombocytopenic purpura; and some types of ... | Aplastic Anemia Pure Red Cell Aplasia Diamond Blackfan Anemia | Immunosuppression T-cells Hematopoiesis Monoclonal Antibody Therapy Immunosuppressive Therapy Aplastic Anemia | null | 1 | arm 1: daclizumab, 1 mg/kg, will be given for a total of 5 intravenous infusions. These subjects may be diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infu... | [
0
] | 1 | [
0
] | intervention 1: Daclizumab, 1mg/kg, every 2 weeks for a total of 5 infusions. | intervention 1: Daclizumab | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 100 | 0 | 0 | 0 | NCT00001962 | 6TERMINATED | 2010-09-01 | 1999-11-01 | National Heart, Lung, and Blood Institute (NHLBI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 349 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women. | Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gai... | Tobacco Use Disorder | smoking cessation Women bupropion weight concerns weight | null | 4 | arm 1: Bupropion SR and a weight concerns psychosocial intervention arm 2: A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion arm 3: Bupropion SR and a time and attention controlled smoking cessation intervention arm 4: A matched placebo ad... | [
0,
1,
1,
2
] | 4 | [
0,
0,
5,
5
] | intervention 1: smoking cessation medication aid intervention 2: A matched placebo pill intervention 3: cognitive behavioral treatment to address weight concners intervention 4: Cognitive behavioral intervention for smoking cessation | intervention 1: Bupropion intervention 2: Placebo intervention 3: weight concerns intervention intervention 4: smoking cessation intervention | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 349 | 0 | 0 | 0 | NCT00006170 | 1COMPLETED | 2010-09-01 | 2000-09-01 | University of Pittsburgh | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 75 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This phase II trial is studying how well medroxyprogesterone works in treating patients with endometrioid adenocarcinoma (cancer) of the uterine corpus (the body of the uterus, not including the cervix). Hormone therapy using medroxyprogesterone may be effective in treating endometrioid cancer. | PRIMARY OBJECTIVES:
I. Compare the efficacy of medroxyprogesterone, in terms of induction of histologic response, in patients with progesterone receptor-positive vs progesterone receptor-negative endometrioid adenocarcinoma of the uterine corpus.
II. Determine the early and late changes in gene expression at 72 hours... | Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation Recurrent Uterine Corpus Carcinoma Stage I Uterine Corpus Cancer Stage II Uterine Corpus Cancer Stage III Uterine Corpus Cancer Stage IV Uterine Corpus Cancer | null | 1 | arm 1: Patients receive medroxyprogesterone intramuscularly once approximately 3 weeks before surgical hysterectomy.
A subset of 15 patients has tissue collected by pipelle biopsy or curettage at baseline, 72 hours after medroxyprogesterone therapy, and during surgery for gene expression arrays. | [
0
] | 3 | [
10,
0,
3
] | intervention 1: Correlative studies intervention 2: Given IM intervention 3: Undergo surgical hysterectomy | intervention 1: Laboratory Biomarker Analysis intervention 2: Medroxyprogesterone intervention 3: Therapeutic Conventional Surgery | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 68 | 0 | 0 | 0 | NCT00064025 | 1COMPLETED | 2010-09-01 | 2004-04-01 | Gynecologic Oncology Group | 5NETWORK | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | true | Deficiency of testosterone, growth hormone, or both hormones can result in osteoporosis. If either hormone is replaced, the condition of the bones improves. The purpose of this study is to determine if dual hormone treatment for men deficient in testosterone and growth hormone improves bone structure more than testoste... | Replacement of testosterone or growth hormone in patients who are deficient improves osteoporosis associated with these deficiencies. In some tissues, such as muscle, the effects of testosterone and growth hormone are additive, but it is not known if the effects are additive in bone as well. This study will compare the... | Hypopituitarism Hypogonadism Growth Hormone Deficiency | null | 2 | arm 1: Testosterone transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day arm 2: AndroGel transdermally 5 g a day for two years | [
0,
1
] | 2 | [
0,
0
] | intervention 1: AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years intervention 2: AndroGel transdermally 5 g a day for two years | intervention 1: Testosterone plus somatropin intervention 2: testosterone | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 35 | 0 | 0 | 0 | NCT00080483 | 1COMPLETED | 2010-09-01 | 2004-03-01 | University of Pennsylvania | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 333 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This was a multicenter, parallel-group, double-blind, randomized, placebo-controlled study that enrolled 333 subjects. These subjects were 12-75 years old with atopic asthma, had elevated serum total Immunoglobulin E (IgE), had a baseline forced expiratory volume in 1 second (FEV1) ≥ 80% predicted, and were on inhaled ... | null | Asthma | Omalizumab (Xolair) Atopic Asthma | null | 2 | arm 1: Omalizumab (Xolair) administered in this study was either a minimum of 0.008 mg/kg/IgE \[IU/mL\] every 2 weeks or a minimum of 0.016 mg/kg/IgE \[IU/mL\] every 4 weeks. arm 2: Placebo administered in this study was either a minimum of 0.008 mg/kg/IgE \[IU/mL\] every 2 weeks or a minimum of 0.016 mg/kg/IgE \[IU/mL... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table... | intervention 1: omalizumab (Xolair) intervention 2: placebo | 0 | null | 328 | 0 | 0 | 0 | NCT00096954 | 1COMPLETED | 2010-09-01 | 2006-02-01 | Genentech, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 64 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This randomized phase II trial is studying how well SB-715992 works in treating patients with advanced or metastatic colorectal cancer. Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. | PRIMARY OBJECTIVES:
I. To determine the objective response rate in patients with advanced or metastatic colorectal cancer treated with SB-715992 once a week for 3 weeks, every 28 days and SB-715992 once every 21 days.
SECONDARY OBJECTIVES:
I. To determine the time to tumor progression, progression free and overall s... | Recurrent Colon Cancer Recurrent Rectal Cancer Stage IIIA Colon Cancer Stage IIIA Rectal Cancer Stage IIIB Colon Cancer Stage IIIB Rectal Cancer Stage IIIC Colon Cancer Stage IIIC Rectal Cancer Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer | null | 2 | arm 1: Patients receive SB-715992 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | [
0,
0
] | 2 | [
0,
10
] | intervention 1: Given IV intervention 2: Correlative studies | intervention 1: ispinesib intervention 2: laboratory biomarker analysis | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 64 | 0 | 0 | 0 | NCT00103311 | 1COMPLETED | 2010-09-01 | 2005-01-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 52 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | null | This randomized phase II is studying how well giving sorafenib with or without gemcitabine works in treating patients with metastatic pancreatic cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy... | PRIMARY OBJECTIVES:
I. To determine the objective response rate in patients with metastatic pancreatic cancer treated with concurrent gemcitabine and BAY43-9006 and sequential BAY 43-9006 followed by gemcitabine/BAY 43-9006 at progression.
SECONDARY OBJECTIVES:
I. To determine the six month overall survival rate, 3 ... | Stage IV Pancreatic Cancer | null | 2 | arm 1: Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II. arm 2: Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15. | [
0,
0
] | 3 | [
0,
0,
10
] | intervention 1: Given PO intervention 2: Given IV intervention 3: Correlative studies | intervention 1: sorafenib tosylate intervention 2: gemcitabine hydrochloride intervention 3: laboratory biomarker analysis | 1 | Duarte | California | United States | -117.97729 | 34.13945 | 52 | 0 | 0 | 0 | NCT00114244 | 1COMPLETED | 2010-09-01 | 2004-12-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 43 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Purpose: There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased EGFR expression in a significant proportion of both esophageal and gastric carcinomas. Inactivation of EGFR through use of a monoclo... | OBJECTIVES:
Primary - To assess the response rate of single-agent cetuximab in patients with advanced esophageal or gastric cancer who have failed 1-2 prior chemotherapy regimens given in the metastatic setting.
Secondary
* To evaluate the duration of response, progression-free survival and overall survival.
* To as... | Esophageal Cancer Gastric Cancer Neoplasm Metastasis | Esophageal Cancer Gastric Cancer Metastatic Esophageal Cancer Metastatic Gastric Cancer Cetuximab Metastatic Esophageal and Gastric Cancer | null | 1 | arm 1: Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity. | [
5
] | 1 | [
0
] | intervention 1: None | intervention 1: Cetuximab | 4 | Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Peabody | Massachusetts | United States | -70.92866 | 42.52787 | 35 | 0 | 0 | 0 | NCT00130689 | 1COMPLETED | 2010-09-01 | 2005-07-01 | Dana-Farber Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 246 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | false | 0ALL | null | To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years. | null | Parkinson Disease | null | 2 | arm 1: Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines arm 2: Requip tablets three times daily (TID) dosing according to manufacturer's guidelines | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Standard marketed product dispensed according to manufacturer's guidelines intervention 2: Standard marketed product dispensed according to manufacturer's guidelines | intervention 1: Mirapex intervention 2: Requip | 21 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Fountain Valley | California | United States | -117.95367 | 33.70918
Los Angeles | California | United States | -118.24368 | 34.05223
New Haven | Connecticut | United States | -72.92816 | 41.30815
M... | 246 | 0 | 0 | 0 | NCT00144300 | 1COMPLETED | 2010-09-01 | 2005-01-01 | Boehringer Ingelheim | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 11 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | true | The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production). | The study is a randomized, double blind, placebo controlled trial. Subjects will be admitted to the General Clinical Research Center (GCRC) as outpatients to undergo their baseline pumping study. One lactation consultant will educate all subjects in the proper technique for pumping on the first day of the study and wil... | Lactation | Lactation Breastfeeding Premature infants Prolactin Primary lactation insufficiency | null | 3 | arm 1: Placebo group normal saline twice per day arm 2: Recombinant human prolactin 60 mcg/kg every 12 hours arm 3: Recombinant human prolactin 60 mcg/kg alternating with normal saline placebo every 12 hours | [
1,
1,
1
] | 3 | [
0,
2,
2
] | intervention 1: 60 mcg/kg every 12 hours intervention 2: 60 mcg/kg given every 12 hours or every 24 hours intervention 3: twice per day | intervention 1: Recombinant Human Prolactin intervention 2: Recombinant human prolactin intervention 3: Normal Saline | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 11 | 0 | 0 | 0 | NCT00181610 | 1COMPLETED | 2010-09-01 | 2004-09-01 | Massachusetts General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with relapsed or refractory cutaneous T-cell lymphoma. | OBJECTIVES:
* Determine the response rates (complete response and partial response) and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib.
* Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label study.
Patient... | Lymphoma | recurrent mycosis fungoides/Sezary syndrome stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III c... | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: bortezomib | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 5 | 0 | 0 | 0 | NCT00182637 | 1COMPLETED | 2010-09-01 | 2004-07-01 | Jonsson Comprehensive Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 20 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | Patients with interstitial cystitis have been well documented to have pelvic floor muscle tenderness as well as pain on bladder distension. Some investigators have even suggested that pelvic floor muscle pain is primarily the cause of bladder problems.
Botulinum toxin A causes muscle relaxation by inhibiting the acety... | Screening Visit:
After being screened by her medical provider, the patient will be given the opportunity to ask questions about the study. She will then be asked to read and sign the consent and then be randomized.
Then, for women of childbearing age, a pregnancy test will be done.
Next, we will ask the patient to f... | Painful Bladder Syndrome Interstitial Cystitis | null | 2 | arm 1: Subjects were injected with Botulinum toxin A in a mix of 50 U diluted in 2 cubic centimeters of normal saline. With the subjects in the dorsal lithotomy position, one injection of 25 international units was given into the bladder neck at the 3 o'clock position and another of 25 international units was given int... | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Botox 25 international units per injection injected in two places in the bladder neck, with option to inject two other tender points with 25 units each intervention 2: Normal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock | intervention 1: Botox intervention 2: normal saline | 0 | null | 20 | 0 | 0 | 0 | NCT00194610 | 1COMPLETED | 2010-09-01 | 2004-05-01 | University of Washington | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 385 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxid... | Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors ... | End-stage Renal Disease | null | 2 | arm 1: 600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months arm 2: placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months | [
1,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: approximately 666 IU daily (1 pill) for 6 months intervention 2: 600 mg daily (2 pills 300 mg each) for 6 months intervention 3: placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months intervention 4: placebo for alpha lipoic acid; 2 pills daily for 6 months | intervention 1: Alpha, gamma, beta, and delta (mixed) tocopherols intervention 2: Alpha lipoic acid intervention 3: Placebo intervention 4: Placebo | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 325 | 0 | 0 | 0 | NCT00237718 | 1COMPLETED | 2010-09-01 | 2006-04-01 | Vanderbilt University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 44 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by surgery. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes neede... | PRIMARY OBJECTIVES:
I. To evaluate the response rate (complete response and partial response) of the combination of BAY 43-9006 with docetaxel and cisplatin or oxaliplatin in patients with gastric and GEJ adenocarcinoma.
II. To evaluate the progression-free survival (PFS) and overall survival.
III. To evaluate the t... | Adenocarcinoma of the Gastroesophageal Junction Metastatic Gastric Cancer Advanced Unresectable Gastric Cancer | Sorafenib Docetaxel Cisplatin gastric cancer gastroesophageal junction adenocarcinoma | null | 1 | arm 1: Patients receive oral BAY 43-9006 400mg twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Given orally intervention 2: Given IV intervention 3: Given IV | intervention 1: BAY 43-9006 intervention 2: docetaxel intervention 3: cisplatin | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 44 | 0 | 0 | 0 | NCT00253370 | 1COMPLETED | 2010-09-01 | 2005-10-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This phase I/II trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the growth of tumor cells by blocking some of the ... | PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of vorinostat in combination with trastuzumab (Herceptin) in patients with metastatic or local chest wall recurrent HER-2-amplified breast cancer. (Phase I) II. To determine the toxic effects of this regimen in these patients. (Phase I) III. To determine t... | Breast Cancer Male Breast Cancer Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer | null | 1 | arm 1: Patients will receive vorinostat by mouth twice a day for 2 weeks. They will also receive a 90-minute infusion of trastuzumab in week 1. | [
0
] | 2 | [
0,
0
] | intervention 1: Given orally intervention 2: Given IV | intervention 1: vorinostat intervention 2: trastuzumab | 25 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United State... | 16 | 0 | 0 | 0 | NCT00258349 | 1COMPLETED | 2010-09-01 | 2006-08-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 361 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | null | Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this study was to see if the frequency of liver fibrosis was different with cyclosporine microemulsion than tacrolimus | null | Liver Transplant Hepatitis C | Liver transplant, adults, hepatitis C, liver fibrosis, cyclosporine microemulsion, tacrolimus | null | 2 | arm 1: The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, the dose of ... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Initial dose of 10-15mg/kg/day either orally, via a nasogastric (NG) tube or intravenously (i.v.) within the first 24 hours post-transplantation. intervention 2: Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses either ... | intervention 1: Cyclosporine A intervention 2: Tacrolimus | 2 | East Hanover | New Jersey | United States | -74.36487 | 40.8201
Zurich | N/A | Switzerland | 8.55 | 47.36667 | 356 | 0 | 0 | 0 | NCT00260208 | 6TERMINATED | 2010-09-01 | 2006-01-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 730 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 0ALL | null | Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill contai... | While perinatal HIV infection has become rare in developed countries through the use of highly active antiretroviral therapy (HAART), it remains a serious problem in developing countries. Botswana has a population of approximately 1.7 million; the prevalence of HIV in Botswana is about 37.4%. In the developed world, HA... | HIV Infections | Treatment Naive MTCT HIV Seronegativity | null | 3 | arm 1: Participants in the TZV Arm (Arm 1A) will be pregnant women who have CD4 counts of 200 cells/mm3 or more. As the intervention, they will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV. arm 2: Participants in the Kaletra Arm (... | [
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily intervention 2: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily intervention 3: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily intervention 4: 200 mg tablet taken orally dai... | intervention 1: Trizivir intervention 2: Lamivudine/Zidovudine intervention 3: Lopinavir/Ritonavir intervention 4: Nevirapine | 4 | Gaborone | N/A | Botswana | 25.90859 | -24.65451
Lobatse | N/A | Botswana | 25.67728 | -25.22435
Mochudi | N/A | Botswana | 26.15 | -24.41667
Molepolole | N/A | Botswana | 25.49508 | -24.40659 | 730 | 0 | 0 | 0 | NCT00270296 | 1COMPLETED | 2010-09-01 | 2006-06-01 | National Institute of Allergy and Infectious Diseases (NIAID) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 21 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary efficacy endpoint will be the proportion of subjects that remain free of progression at the 27th week following the onset of treatment. Secondary objectives include the subject's time in weeks from treatment onset to documented disease progression as assessed by the RECIST criteria, response rate, median an... | This is a phase II study to assess the proportion of subjects that remain progression-free by the 27th week following the onset of treatment and to assess the efficacy of the combination of Bevacizumab and Erlotinib in prolonging time to progression in subjects with inoperable and metastatic hepatocellular carcinoma. S... | Hepatocellular Carcinoma | Inoperable and Metastatic Hepatocellular Carcinoma | null | 1 | arm 1: Subjects will be treated with bevacizumab and erlotinib | [
0
] | 2 | [
0,
0
] | intervention 1: 15 mg/KG I.V. every 21 days intervention 2: 150 mg orally every day | intervention 1: Bevacizumab intervention 2: Erlotinib | 2 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Kansas City | Kansas | United States | -94.62746 | 39.11417 | 21 | 0 | 0 | 0 | NCT00287222 | 1COMPLETED | 2010-09-01 | 2006-02-01 | University of Arkansas | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 51 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | This phase II trial is studying how well cediranib maleate works in treating patients with malignant mesothelioma that cannot be removed by surgery. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor | We conducted a multi-center phase II trial of cediranib in patients with unresectable, histologically-confirmed malignant mesothelioma (MM) who had received \<=1 prior regimen of chemotherapy. The primary endpoint was objective response rate. Initial cediranib dosing was 45 mg daily during a 28-day cycle. Due to substa... | Advanced Malignant Mesothelioma Epithelial Mesothelioma Localized Malignant Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma | null | 1 | arm 1: Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily. | [
0
] | 1 | [
0
] | intervention 1: Given orally | intervention 1: cediranib maleate | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 51 | 0 | 0 | 0 | NCT00309946 | 1COMPLETED | 2010-09-01 | 2005-12-01 | National Cancer Institute (NCI) | 0NIH | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer. | To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. Th... | Non-Small Cell Lung Carcinoma (NSCLC) | Advanced NSCLC Non-Small Cell Lung Carcinoma Stage IV NSCLC | null | 1 | arm 1: Iressa plus thoracic RT at the following dose levels:
* Level 1: 42.0 Gy in 10 fractions of 4.2 Gy
* Level 2: 50.4 Gy in 12 fractions of 4.2 Gy
* Level 3: 63.0 Gy in 15 fractions of 4.2 Gy | [
0
] | 2 | [
0,
4
] | intervention 1: None intervention 2: None | intervention 1: ZD1839 (Iressa) intervention 2: Thoracic Radiotherapy | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 12 | 0 | 0 | 0 | NCT00328562 | 1COMPLETED | 2010-09-01 | 2003-12-01 | Sidney Kimmel Cancer Center at Thomas Jefferson University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 71 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The hypothesis is that salsalate therapy may be an effective and safe method to modulate inflammation in metabolically-critical tissues and thus reduce insulin resistance and its related complications.
The objectives of the study are to (1) determine whether salsalate therapy improves insulin resistance in subjects wi... | Recent studies demonstrate an important role for sub-acute, chronic inflammation in the development of insulin resistance, type 2 diabetes mellitus (T2 DM) and cardiovascular disease (CVD). A broad body of data indicate that obesity and high fat or "Western" diets activate sub-acute inflammatory processes in fat and li... | Atherosclerosis Cardiovascular Disease Inflammation Insulin Resistance Noninsulin-dependent Diabetes Mellitus | Cardiovascular Disease Inflammation Insulin Resistance Type 2 DM | null | 2 | arm 1: Matching placebo arm 2: Salsalate | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Participants were randomized to 12-week treatment with up to 4 g/day. intervention 2: Participants were randomized to 12-week treatment matching the active salsalate arm. | intervention 1: Salsalate intervention 2: Placebo | 1 | Phoenix | Arizona | United States | -112.07404 | 33.44838 | 70 | 0 | 0 | 0 | NCT00330733 | 1COMPLETED | 2010-09-01 | 2007-01-01 | VA Office of Research and Development | 1FED | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 105 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 2MALE | true | The primary objective of this study is to demonstrate the opioid-sparing efficacy of parecoxib 40 mg intravenously given as a loading dose followed by 20 mg intravenously in the 24 hours after the end of surgery. | The study was terminated due to lack of recruitment due to competing alternative operation methods on 13September 2010. The decision to terminate the trial was not based on any safety concerns. | Pain, Postoperative | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or af... | intervention 1: Morphine, Parecoxib intervention 2: Morphine, Placebo | 4 | Cologne | N/A | Germany | 6.95 | 50.93333
Essen | N/A | Germany | 7.01228 | 51.45657
Heidelberg | N/A | Germany | 8.69079 | 49.40768
Reutlingen | N/A | Germany | 9.20427 | 48.49144 | 105 | 0 | 0 | 0 | NCT00346268 | 6TERMINATED | 2010-09-01 | 2006-12-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 72 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The main goals of the study are to evaluate the effect of Exenatide on endothelial-dependent vasodilation, as measured by flow mediated dilation (FMD), to evaluate the effect on endothelial-independent vasodilation, as measured by nitroglycerin (TNG) response, and to evaluate the effect on arterial stiffness, as measur... | The trial is a randomized, controlled, comparator study. Subjects and investigators will not be blinded due to the nature of the treatment. After providing informed consent and meeting the inclusion and exclusion criteria, subjects will undergo baseline studies then be randomized to either treatment with Exenatide or L... | Type 2 Diabetes Mellitus | endothelial dysfunction subclinical inflammation flow mediated brachial artery dilation pulse wave analysis glucagon like polypeptide mimetics type 2 diabetes mellitus | null | 2 | arm 1: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve fasting blood glucose of 100 mg/dl and avoid hypoglycemia. arm 2: Exenatide 5ug twice daily for 4 weeks followed by 10 ug twice daily for 8 weeks. | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Exenetide 5ug twice daily for 4 weeks, then 10ug twice daily for 8 weeks intervention 2: Glargine insulin 10-20 units once daily and subsequently adjusted per protocol to achieve a fasting glucose of 100mg/dl and avoid hypoglycemia. | intervention 1: Exenatide intervention 2: Glargine Insulin | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 53 | 0 | 0 | 0 | NCT00353834 | 1COMPLETED | 2010-09-01 | 2006-08-01 | Joslin Diabetes Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 38 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic steatosis. In order to enroll subject groups with varying degrees of risk, the study has included multiple cohorts (Cohorts A-G). Additions ... | This was a randomized, double-blind, placebo-controlled study to measure the effect of treatment with mipomersen on liver triglyceride (TG) content in patients with varying degrees of hyperlipidemia and risk for hepatic steatosis.
The original study design included 4 cohorts (Cohorts A through D). Subsequent protocol ... | Lipid Metabolism, Inborn Errors Hyperlipidemias Metabolic Diseases Hypolipoproteinemia Hypolipoproteinemias Hypobetalipoproteinemias Metabolism, Inborn Errors Genetic Diseases, Inborn Infant, Newborn, Diseases Congenital Abnormalities Metabolic Disorder Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders | LDL-cholesterol apoB-100 apoB-48 triglyceride HeFH FHBL | null | 9 | arm 1: Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks. Injections were given subcutaneously (sc) on days 1, 4, 8, 11, 15 and 22. arm 2: Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks. Injections were given subcutaneously (sc) on days 1, 4... | [
0,
2,
0,
2,
0,
2,
4,
0,
2
] | 2 | [
0,
0
] | intervention 1: 200 mg subcutaneous injections intervention 2: subcutaneous injections | intervention 1: mipomersen intervention 2: Placebo | 1 | Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 | 39 | 0 | 0 | 0 | NCT00362180 | 1COMPLETED | 2010-09-01 | 2006-07-01 | Kastle Therapeutics, LLC | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 58 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to examine whether insomnia due to chronic low back pain can improve with use of eszopiclone. | There is a great need to develop effective treatments for insomnia in patients with chronic low-back pain. Chronic low-back pain is among the most prevalent of all health complaints, is associated with enormous health-care and productivity costs, reduced quality of life, and limitation of function and is almost univers... | Primary Insomnia | Insomnia Low Back Pain Hypnotics Eszopiclone Pain Disability | null | 2 | arm 1: Placebo arm 2: Eszopiclone | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Eszopiclone 3 mg po nightly for duration of study blind phase. intervention 2: Placebo nightly over duration of double blind study phase | intervention 1: Eszopiclone intervention 2: Placebo | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 58 | 0 | 0 | 0 | NCT00365976 | 1COMPLETED | 2010-09-01 | 2006-08-01 | Duke University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 2MALE | null | The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence. | null | Cocaine Dependence | cocaine dependence risperidal MRI | null | 2 | arm 1: Identical placebo tablets and injections arm 2: Risperidone 1-2 mg tablets and Risperidone 25 mg injections | [
2,
1
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Risperidone intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 31 | 0 | 0 | 0 | NCT00385801 | 1COMPLETED | 2010-09-01 | 2005-09-01 | Massachusetts General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 146 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease | To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation \[aka peripheral blood stem cell (PBSC)\]. | Hodgkin Disease Hodgkin's Lymphoma Lymphoma | null | 1 | arm 1: Gemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide. | [
0
] | 6 | [
0,
0,
0,
0,
0,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None | intervention 1: Gemcitabine intervention 2: Vinorelbine intervention 3: Carmustine intervention 4: Etoposide intervention 5: Cyclophosphamide intervention 6: Autologous HCT | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 146 | 0 | 0 | 0 | NCT00388349 | 1COMPLETED | 2010-09-01 | 2001-09-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes... | OBJECTIVES:
Primary
* Determine the response rate in patients with irinotecan hydrochloride- and cisplatin-refractory metastatic esophageal, gastroesophageal junction, or gastric cancer treated with cetuximab, cisplatin, and irinotecan hydrochloride.
Secondary
* Determine the median survival of patients treated wit... | Esophageal Cancer Gastric Cancer | adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus recurrent esophageal cancer recurrent gastric cancer adenocarcinoma of the stomach stage IV esophageal cancer stage IV gastric cancer | null | 1 | arm 1: Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive ir... | [
0
] | 6 | [
2,
0,
0,
10,
10,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None | intervention 1: cetuximab intervention 2: cisplatin intervention 3: irinotecan hydrochloride intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis intervention 6: biopsy | 1 | New York | New York | United States | -74.00597 | 40.71427 | 16 | 0 | 0 | 0 | NCT00397904 | 1COMPLETED | 2010-09-01 | 2006-10-01 | Memorial Sloan Kettering Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 5 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to investigate over a 6 month period the effect of octreotide therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning calories, biomarkers of weight regulation and growth hormone markers in children and young Adults with Prader-Willi Syndrome(PWS). | Obesity continues to be a prevalent health concern affecting every race of the American population. According to data from the World Health Organization, 54% of U.S. adults are overweight (body mass index (BMI) \>25 kg/m2 ) and 22% are obese (BMI \>30 kg/m2) (1). In addition, 25% of U.S. children are overweight or obes... | Prader-Willi Syndrome | Childhood obesity Prader-Willi Syndrome Octreotide Ghrelin Weight loss Body composition Energy expenditure | null | 2 | arm 1: Octreotide to be administered by subcutaneous injection three times daily while on study arm 2: Placebo to be administered by subcutaneous injection three times daily while on study | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Octreotide to be administered by subcutaneous injection three times daily intervention 2: Placebo to be administered by subcutaneous injection three times daily while on study | intervention 1: Octreotide intervention 2: Placebo | 1 | Durham | North Carolina | United States | -78.89862 | 35.99403 | 5 | 0 | 0 | 0 | NCT00399893 | 6TERMINATED | 2010-09-01 | 2006-12-01 | Duke University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 25 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Purpose of this study is to examine the effectiveness of an experimental psychotherapy (talk therapy) for the treatment of bipolar II depression. The name of this psychotherapy is Interpersonal and Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). Subjects will be randomly assigned to receive either IPSRT-B... | The proposed pilot study is an experimental design intended to investigate the preliminary efficacy of Interpersonal Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). A total of 56 eligible subjects with a diagnosis of bipolar II disorder will be randomly assigned to one of two treatment groups : Seroquel (... | Bipolar II Disorder | Interpersonal Therapy Social Rhythm Therapy Bipolar Disorder Depression Seroquel | null | 2 | arm 1: Subjects randomized to the Psychotherapy arm will receive Interpersonal and Social Rhythm Therapy (IPSRT-BPII) arm 2: Subjects randomized to the medication arm will receive the FDA approved medication Seroquel (quetiapine) | [
0,
0
] | 2 | [
5,
0
] | intervention 1: IPSRT is comprised of three components: psychoeducation, social rhythm therapy, and standard IPT as developed for unipolar depression.
Psychoeducation focuses on a) the illness and its consequences, b) treatment options and associated side effects, and c) prodromal symptoms/detection of early warning s... | intervention 1: Interpersonal and Social Rhythm Therapy (IPSRT-BPII) intervention 2: Seroquel | 1 | Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 | 25 | 0 | 0 | 0 | NCT00411463 | 1COMPLETED | 2010-09-01 | 2006-12-01 | University of Pittsburgh | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 40 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | To compare the difference of a marker of cellular proliferation in all bronchial biopsy specimens of former smokers stratified by lung cancer risk, collected before and after treatment per patient between the enzastaurin and placebo groups. | null | Lung Cancer | Healthy Prevention | null | 2 | arm 1: Treatment with enzastaurin 500 milligrams (mg) orally (po) once daily (QD) given as 4 tablets (125 mg each). arm 2: Treatment with placebo po QD appearing identical to enzastaurin. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 500 mg po QD for 6 months intervention 2: po QD for 6 months | intervention 1: Enzastaurin intervention 2: Placebo | 1 | Tampa | Florida | United States | -82.45843 | 27.94752 | 39 | 0 | 0 | 0 | NCT00414960 | 1COMPLETED | 2010-09-01 | 2007-12-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 189 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal ... | Group 1 (Luminal A):
* Standard treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles.
EC x 4 -\> D x 4
* Selective treatment: Postmenopausal patients: exemestane x 6 mon... | Breast Cancer | Her2neu negative breast cancer. Neoadjuvant treatment. | null | 4 | arm 1: Standard treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. arm 2: Selective treatment:
Postmenopausal patients: exemestane x 6 months Premenopausal patients: go... | [
1,
0,
1,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None | intervention 1: Epirubicin intervention 2: Cyclophosphamide intervention 3: Docetaxel intervention 4: Exemestane intervention 5: Goserelin intervention 6: Carboplatin | 12 | Sabadell | Barcelona | Spain | 2.10942 | 41.54329
Terrassa | Barcelona | Spain | 2.01667 | 41.56667
Donostia / San Sebastian | Gipuzkoa | Spain | -1.97499 | 43.31283
A Coruña | N/A | Spain | -8.396 | 43.37135
A Coruña | N/A | Spain | -8.396 | 43.37135
Alicante | N/A | Spain | -0.48149 | 38.34517
Barcelona | N/A | Spain... | 184 | 0 | 0 | 0 | NCT00432172 | 1COMPLETED | 2010-09-01 | 2007-04-24 | Spanish Breast Cancer Research Group | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 53 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | true | 1FEMALE | false | The purpose of this research study is to investigate if the incidence of nausea and vomiting that subjects experience during and after a Cesarean section can be reduced by giving a shot of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration. | This research project is designed to study the medication ephedrine, when it is given as a routine part of the anesthesia for elective Cesarean section. Ephedrine is a medication that is widely used in labor and in vaginal and operative (Cesarean section) deliveries to help maintain a woman's blood pressure within its ... | Nausea Vomiting Cesarean Section | Nausea Vomiting Cesarean Section | null | 2 | arm 1: Drug: Saline Placebo 0.5 mL, IM (in the muscle), one time arm 2: Drug: Ephedrine \[Synonyms: Ephedra, Ephedrinum\] 25 mg, IM (in the muscle), one time | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 25 mg, IM (in the muscle), one time intervention 2: 0.5 mL, IM (in the muscle), one time | intervention 1: Ephedrine [Synonyms: Ephedra, Ephedrinum] intervention 2: Saline Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 53 | 0 | 0 | 0 | NCT00432991 | 1COMPLETED | 2010-09-01 | 2007-02-01 | Weill Medical College of Cornell University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill ... | OBJECTIVES:
Primary
* Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma.
Secondary
* Determine the antibody responses to pneumococcal serotypes in patients ... | Multiple Myeloma and Plasma Cell Neoplasm | stage II multiple myeloma stage III multiple myeloma refractory multiple myeloma | null | 2 | arm 1: Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (a... | [
0,
0
] | 2 | [
2,
0
] | intervention 1: Given intramuscularly intervention 2: Given orally | intervention 1: pneumococcal polyvalent vaccine intervention 2: lenalidomide | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 22 | 0 | 0 | 0 | NCT00445484 | 1COMPLETED | 2010-09-01 | 2007-01-01 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 58 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 1FEMALE | null | This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to... | null | Breast Cancer | null | 2 | arm 1: Chemotherapy, schedule and dose at the investigator's discretion. arm 2: Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion. | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks intervention 2: Schedule and dose at the investigator's discretion | intervention 1: trastuzumab intervention 2: Chemotherapy | 35 | Avellino | N/A | Italy | 14.79103 | 40.91494
Brescia | N/A | Italy | 10.21472 | 45.53558
Candiolo | N/A | Italy | 7.59812 | 44.95858
Carrara | N/A | Italy | 10.09789 | 44.07926
Cona (Ferrara) | N/A | Italy | 11.7069 | 44.80583
Cosenza | N/A | Italy | 16.25307 | 39.2989
Crotone - Kr | N/A | Italy | N/A | N/A
Fano | N/A ... | 54 | 0 | 0 | 0 | NCT00448279 | 1COMPLETED | 2010-09-01 | 2007-04-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
2
] | 5 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events.
Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant conjunctival neop... | Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Its analog, Avastin has also been employed to treat macular edema, proliferative diabetic retinopathy and wet age related macular degeneration. Ranibizumab binds to an... | Conjunctival Neoplasms | null | 1 | arm 1: Patients will receive subconjunctival ranibizumab every 2-4 weeks. | [
0
] | 1 | [
0
] | intervention 1: Subconjunctival injection of drug every 2 to 4 weeks | intervention 1: ranibizumab | 1 | New York | New York | United States | -74.00597 | 40.71427 | 5 | 0 | 0 | 0 | NCT00456495 | 1COMPLETED | 2010-09-01 | 2007-03-01 | The New York Eye Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
4
] | 147 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent... | This is an open label trial.
The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing ... | Hereditary Angioedema (HAE) | null | 1 | arm 1: DX-88 (ecallantide) Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits:... | [
0
] | 1 | [
0
] | intervention 1: solution for SC injection, one 30 mg dose per HAE attack | intervention 1: ecallantide | 41 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Berkeley | California | United States | -122.27275 | 37.87159
Crescent City | California | United States | -124.20175 | 41.75595
Granad... | 147 | 0 | 0 | 0 | NCT00456508 | 1COMPLETED | 2010-09-01 | 2007-04-01 | Shire | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 41 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 1FEMALE | false | This study will look at the effect of exenatide, a drug which has been approved for the treatment of type 2 diabetes, on body weight, appetite and energy expenditure among moderately obese women without diabetes.
The study is 35 weeks long and includes 19 outpatient visits. Participants will receive exenatide for 16 w... | This study will examine the effect of exenatide on body weight, energy expenditure, satiety, sleep, and metabolic parameters in healthy, moderately obese women (BMI 28-35 kg/m2). We will look at 2 populations of women, one with normal glucose metabolism and one with impaired glucose homeostasis (IGH)--either impaired f... | Obesity Impaired Glucose Tolerance | obesity double blind placebo controlled weight loss appetite energy expenditure | null | 2 | arm 1: Started on Exenatide, 3 week washout, start placebo arm 2: Started on placebo, 3 week washout, start exenatide | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 5 microgram twice a day for two week and then 10 mcg for remaining 15 weeks intervention 2: Twice daily injection of placebo | intervention 1: exenatide intervention 2: Placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 41 | 0 | 0 | 0 | NCT00456885 | 1COMPLETED | 2010-09-01 | 2007-04-01 | Beth Israel Deaconess Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage III or stage IV pancreatic cancer. | OBJECTIVES:
Primary
* Determine the progression-free survival (PFS) of patients with stage III or IV adenocarcinoma of the pancreas treated with erlotinib hydrochloride as first- or second-line therapy.
Secondary
* Determine the proportion of patients with a radiological response to this drug.
* Determine the overa... | Pancreatic Cancer | adenocarcinoma of the pancreas recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer | null | 1 | arm 1: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity | [
0
] | 3 | [
0,
10,
10
] | intervention 1: Oral intervention 2: Correlative Study intervention 3: Correlative Study | intervention 1: erlotinib hydrochloride intervention 2: immunohistochemistry staining method intervention 3: laboratory biomarker analysis | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 18 | 0 | 0 | 0 | NCT00470535 | 6TERMINATED | 2010-09-01 | 2007-01-01 | Roswell Park Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,176 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoarthritis of the knee. | null | Osteoarthritis | Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability | null | 2 | arm 1: SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months arm 2: SMC021 Placebo, orally twice daily during 24 months | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 0.8mg SMC021 (Oral Calcitoinin) twice daily intervention 2: Placebo orally, twice daily | intervention 1: SMC021 Oral Calcitonin intervention 2: SMC021 Placebo | 9 | Pardubice | N/A | Czechia | 15.77659 | 50.04075
Aalborg | N/A | Denmark | 9.9187 | 57.048
Ballerup Municipality | N/A | Denmark | 12.36328 | 55.73165
Vejle | N/A | Denmark | 9.5357 | 55.70927
Tallinn | N/A | Estonia | 24.75353 | 59.43696
Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
Bialystok | N/A | Poland | 23.1... | 1,169 | 0 | 0 | 0 | NCT00486434 | 1COMPLETED | 2010-09-01 | 2007-05-01 | Nordic Bioscience A/S | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 59 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL) | null | Lymphoma, Follicular | CHOP (cyclophosphamide,doxorubicin,vincristine,prednisolone) ofatumumab | null | 2 | arm 1: Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg arm 2: Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300... | [
1,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given intervention 2: Cyclophosphamide 750 mg/m2 iv for ... | intervention 1: Ofatumumab intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisolone, Prednisone or equivalent | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 116 | 0 | 0 | 0 | NCT00494780 | 1COMPLETED | 2010-09-01 | 2007-06-01 | GlaxoSmithKline | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 181 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. A... | null | Pulmonary Disease, Chronic Obstructive | Bronchitis, Chronic; Emphysema | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Aclidinium Bromide, 200μg. Once daily oral inhalation. intervention 2: Dose matched placebo, once daily oral inhalation. | intervention 1: Aclidinium Bromide intervention 2: Placebo | 52 | Jasper | Alabama | United States | -87.27751 | 33.83122
Phoenix | Arizona | United States | -112.07404 | 33.44838
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento |... | 181 | 0 | 0 | 0 | NCT00500318 | 1COMPLETED | 2010-09-01 | 2007-07-01 | AstraZeneca | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2,
3
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of the skin and internal organs and widespread vasculopathy. Patients with SSc are classified according to the extent of cutaneous sclerosis: patients with limited SSc have skin thickening of the face, neck, and distal extremities, while those ... | null | Scleroderma, Systemic | null | 1 | arm 1: 100 mg daily and increase by 100mg daily every 2 weeks to a maximum of 400 mg daily as tolerated | [
0
] | 1 | [
0
] | intervention 1: 100 mg orally daily increased by 100 mg/day every 2 weeks to maximum of 400 mg daily as tolerated. Treatment for 6 months total. | intervention 1: Imatinib mesylate | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 9 | 0 | 0 | 0 | NCT00506831 | 1COMPLETED | 2010-09-01 | 2007-07-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The efficacy of inhaled corticosteroids (ICS) in asthmatic subjects showing no sputum eosinophils is controversial. The broad aim of this study is to assess whether ICS alone or in combination with long-acting beta-2 agonists are an effective treatment in non-eosinophilic asthmatic subjects. Methods: The investigators ... | General objective: To assess whether inhaled corticosteroids alone or in combination with long-acting beta-2 agonists are an effective treatment in non-eosinophilic asthmatic subjects.
Specific objective 1. To compare the change in clinical and functional outcomes after treatment with fluticasone or placebo in non-eos... | Asthma | Asthma Non-eosinophilic Asthma sputum eosinophils Inhaled Corticosteroids | null | 2 | arm 1: Intervention : treatment with inhaled corticosteroids (Fluticasone) will be administered to this group arm 2: treatment with placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: Fluticasone 250mcg bid for one month | intervention 1: Placebo (sham inhaler) intervention 2: Fluticasone | 7 | Calgary | Alberta | Canada | -114.08529 | 51.05011
Vancouver | British Columbia | Canada | -123.11934 | 49.24966
Hamilton | Ontario | Canada | -79.84963 | 43.25011
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Montreal | Quebec | Canada | -73.58781 | 45.50884
Montreal | Quebec | Canada | -73.58781 | 45.50884
Québec ... | 12 | 0 | 0 | 0 | NCT00509197 | 6TERMINATED | 2010-09-01 | 2007-10-01 | Université de Montréal | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 18 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | true | RATIONALE: Calcitriol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. Dexamethasone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with dexamethasone may be an effective treatment for prostate cancer that did... | OBJECTIVES:
* To investigate the response rate in patients with androgen-independent prostate cancer treated with calcitriol and dexamethasone.
* To evaluate the toxicity of high-dose calcitriol and dexamethasone in these patients.
OUTLINE: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV ov... | Prostate Cancer | recurrent prostate cancer | null | 1 | arm 1: Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly. | [
0
] | 4 | [
7,
0,
6,
10
] | intervention 1: IV intervention 2: Oral intervention 3: Correlative Study intervention 4: Correlative Study | intervention 1: calcitriol intervention 2: dexamethasone intervention 3: protein expression analysis intervention 4: laboratory biomarker analysis | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 18 | 0 | 0 | 0 | NCT00524589 | 6TERMINATED | 2010-09-01 | 2006-04-01 | Roswell Park Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis. | null | Uveitis | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 40 mg delivered every 2 weeks by subcutaneous injection | intervention 1: Adalimumab | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 31 | 0 | 0 | 0 | NCT00525902 | 1COMPLETED | 2010-09-01 | 2008-01-01 | Oregon Health and Science University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving c... | OBJECTIVES:
Primary
* Determine the safety and tolerability of selenomethionine in combination with chemotherapy and radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
* Determine if the incidence of excessive adverse events, in the form of esophagitis, pneumonitis, and myelosup... | Lung Cancer | squamous cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer adenosquamous cell lung cancer | null | 1 | arm 1: Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation | [
0
] | 5 | [
7,
0,
0,
10,
4
] | intervention 1: Oral Twice daily intervention 2: Weekly IV intervention 3: Weekly IV intervention 4: Correlative Study intervention 5: Undergoing radiation Therapy | intervention 1: selenomethionine intervention 2: carboplatin intervention 3: paclitaxel intervention 4: laboratory biomarker analysis intervention 5: radiation therapy | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 16 | 0 | 0 | 0 | NCT00526890 | 6TERMINATED | 2010-09-01 | 2006-10-01 | Roswell Park Cancer Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 25 | null | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | true | This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults. | null | Autism | Autistic Disorder | null | 1 | arm 1: 8-Week Open-Label | [
5
] | 1 | [
0
] | intervention 1: Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day. | intervention 1: Paliperidone ER | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 25 | 0 | 0 | 0 | NCT00549562 | 1COMPLETED | 2010-09-01 | 2007-11-01 | Indiana University School of Medicine | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis. | After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and... | Gastroparesis Gastroesophageal Reflux | gastroparesis gastroesophageal reflux | null | 1 | arm 1: Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg tw... | [
0
] | 1 | [
0
] | intervention 1: 10mg orally four times per day | intervention 1: domperidone | 1 | New York | New York | United States | -74.00597 | 40.71427 | 6 | 0 | 0 | 0 | NCT00552422 | 6TERMINATED | 2010-09-01 | 2007-03-01 | David J. Lederer, M.D. | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 72 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer. Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclopho... | null | Breast Cancer | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 15mg/kg iv on day 1 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: As prescribed | intervention 1: bevacizumab [Avastin] intervention 2: Docetaxel intervention 3: Standard chemotherapy | 6 | Sabadell, Barcelona | Barcelona | Spain | N/A | N/A
Córdoba | Cordoba | Spain | -4.77275 | 37.89155
Jaén | Jaen | Spain | -3.79028 | 37.76922
Lleida | Lerida | Spain | 0.62218 | 41.61674
Málaga | Malaga | Spain | -4.42034 | 36.72016
Zaragoza | Zaragoza | Spain | -0.87734 | 41.65606 | 72 | 0 | 0 | 0 | NCT00559754 | 1COMPLETED | 2010-09-01 | 2007-12-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
5
] | 45 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study is an 8-week, randomized, double-blind, placebo-controlled trial of intranasal insulin as an adjunctive therapy, with a 4-week follow-up, in 60 non-diabetic schizophrenia subjects to examine insulin's effect on psychopathology and cognition. In addition, the study will examine insulin's effects on weight, fo... | The specific aims include:
Primary aims
1. Examine the efficacy of intranasal regular insulin (40 IU 4 times per day) in improving cognitive deficits in patients with schizophrenia.
2. Examine the efficacy of intranasal regular insulin in improving negative symptoms and positive symptoms of schizophrenia.
Secondary ... | Schizophrenia | cognition, psychopathology | null | 2 | arm 1: Intranasal Insulin Treatment arm 2: Drug: Placebo | [
0,
2
] | 1 | [
0
] | intervention 1: intranasal, 40IU, 4 times daily | intervention 1: Insulin or Placebo | 1 | Worcester | Massachusetts | United States | -71.80229 | 42.26259 | 45 | 0 | 0 | 0 | NCT00575666 | 1COMPLETED | 2010-09-01 | 2007-12-01 | University of Massachusetts, Worcester | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 139 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | false | 0ALL | null | This study will evaluate the efficacy of Octreotide LAR in preventing chemotherapy-induced diarrhea (with regimens that contain 5 fluorouracil, irinotecan and capecitabine)in patients with colorectal cancer. | Eligible patients will have a diagnosis of colorectal cancer, and will be candidates to adjuvant chemotherapy or first-line chemotherapy for metastatic disease with a regimen containing fluorouracil, capecitabine and/or irinotecan. Eligible chemotherapy regimens include Irinotecan, Leucovorin (folinic acid), and Fluoro... | Chemotherapy-induced Diarrhea | Colorectal cancer diarrhea drug therapy octreotide fluorouracil irinotecan capecitabine prevention | null | 2 | arm 1: Prevention of Chemotherapy Induced Diarrhea (CID) arm 2: Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. | [
0,
5
] | 2 | [
0,
10
] | intervention 1: Patients will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide ... | intervention 1: Octreotide Long Acting Release intervention 2: Standard Treatment | 11 | Belo Horizonte | N/A | Brazil | -43.93778 | -19.92083
Florianópolis | N/A | Brazil | -48.54917 | -27.59667
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
Salvador | N/A | Brazil | -38.49096 | -12.97563
Salvador | N/A | Brazil | -38.49096 | -12.97563
Santo André | N/A | Brazil | -46.53833 | -23.66389
São Paulo | N/... | 139 | 0 | 0 | 0 | NCT00582426 | 1COMPLETED | 2010-09-01 | 2008-04-01 | Novartis Pharmaceuticals | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 88 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Glucagon-like Peptide-1 (GLP-1) is an important incretin hormone which acts as a powerful insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the therapeutic armamentarium for the treatment ... | null | Diabetes | GLP-1 Insulin Secretion | null | 1 | arm 1: All participants recieved GLP-1 intravenously at 0.75 pmol/kg/min for the first hour and then at 1.5 pmol/kg/min for the next hour | [
0
] | 1 | [
0
] | intervention 1: GLP-1 infused at 0.75 pmol/kg/min from 121-180 minutes, GLP-1 infused at 1.55 pmol/kg/min from 181-240 minutes, | intervention 1: GLP-1 | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 88 | 0 | 0 | 0 | NCT00588380 | 1COMPLETED | 2010-09-01 | 2007-11-01 | Mayo Clinic | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 65 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | The purpose of this research study is to:
* see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
* see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
* see if patients whose tumor does shrink with gefitinib treatment are more likely to have a m... | This is a phase II, single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable.
Patients must have 1 or more of the follow... | Lung Cancer Non-small Cell Lung Cancer Bronchioloalveolar Cancer | Lung Cancer Non-small cell lung cancer Gefitnib Cancer NSCLC bronchioloalveolar cancer smoker | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.
Patients who have had at least a minor response to gefitinib therapy preoperatively (\> 25% reduction... | intervention 1: Gefitinib | 1 | New York | New York | United States | -74.00597 | 40.71427 | 65 | 0 | 0 | 0 | NCT00588445 | 1COMPLETED | 2010-09-01 | 2004-06-01 | Memorial Sloan Kettering Cancer Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This will be a 12-week open-label pilot treatment study for children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder (OCD) who are adequately mood stabilized on a stable regimen based on standard clinical care. Specific hypotheses are as follows:
Hypoth... | As no systemic data is available regarding the efficacy and safety of selective serotonin reuptake inhibitors (SSRI) in the treatment of OCD+BPD children, it calls for a preliminary open pilot treatment study to explore these issues as a logical first step that could lead to systematic randomized controlled trials in t... | Pediatric Bipolar Disorder Pediatric OCD | bipolar disorder obsessive compulsive disorder Prozac | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: capsules, dose range of 10mgQD - 60mgQD, given daily for 12 weeks | intervention 1: fluoxetine | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 11 | 0 | 0 | 0 | NCT00592852 | 6TERMINATED | 2010-09-01 | 2005-12-01 | Massachusetts General Hospital | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 1,502 | RANDOMIZED | PARALLEL | 1PREVENTION | 1SINGLE | false | 0ALL | true | The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections. | Sternal wound infection (SWI) is a significant problem in cardiac surgical subjects,in particular in those with risk factors such as diabetes and obesity. There is a long unmet need for an intervention that can reduce the incidence and severity of SWIs in high-risk subjects.
Gentamicin is an antibiotic that is effecti... | Cardiac Surgery Sternal Wound Infection | obesity diabetes | null | 2 | arm 1: Insertion of 2 gentamicin-collagen sponges between the sternal halves before closure of the sternotomy arm 2: Standard of care, ie, insertion of no gentamicin-collagen sponge. | [
0,
4
] | 1 | [
0
] | intervention 1: 100-cm2 sponge | intervention 1: gentamicin-collagen sponge dipped in saline | 43 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Florence | Alabama | United States | -87.67725 | 34.79981
Pasadena | California | United States | -118.14452 | 34.14778
San Francisco | California | United States | -122.41942 | 37.77493
Brandon | Florida | United States | -82.28592 | 27.9378
Jacksonville | Fl... | 1,502 | 0 | 0 | 0 | NCT00600483 | 1COMPLETED | 2010-09-01 | 2007-12-01 | Innocoll | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | -0 |
[
4
] | 602 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery. | Surgical wound infection (SWI) is a significant problem in colorectal surgery. Despite the use of routine bowel preparation and prophylactic antibiotics the incidence of SWI is at least 15% in patients undergoing colorectal surgical procedures.Therefore, there is a long unmet need for an intervention that can reduce th... | Colorectal Surgery Surgical Wound Infection | Colorectal surgery | null | 2 | arm 1: Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). arm 2: Standard of care, ie, no gentamicin-collagen sponge. | [
0,
4
] | 1 | [
0
] | intervention 1: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | intervention 1: gentamicin-collagen sponge dipped in saline | 39 | Florence | Alabama | United States | -87.67725 | 34.79981
Mobile | Alabama | United States | -88.04305 | 30.69436
Laguna Hills | California | United States | -117.71283 | 33.61252
Los Angeles | California | United States | -118.24368 | 34.05223
Stanford | California | United States | -122.16608 | 37.42411
Aurora | Colo... | 602 | 0 | 0 | 0 | NCT00600925 | 1COMPLETED | 2010-09-01 | 2008-01-01 | Innocoll | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 231 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT). | null | Type 2 Diabetes Mellitus | Type 2 Diabetes Mellitus Canakinumab ACZ885 IL-1B antagonist metformin glycemic control insulin sensitivity | null | 2 | arm 1: Eligible participants were assigned to receive canakinumab in one of four cohorts; 1) Single IV infusion of canakinumab 0.3 mg/kg; 2) Singe IV infusion of canakinumab 10 mg/kg; 3) single IV infusion of canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of canakinumab 0.03 mg/kg.
All partic... | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg. intervention 2: Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or... | intervention 1: Canakinumab intervention 2: Placebo intervention 3: Metformin | 13 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Miami | Florida | United States | -80.19366 | 25.77427
Miami | Florida | United States | -80.19366 | 25.77427
MD | Maryland | United States | N/A | N/A
Portland | Oregon | United States | -122.67621 | 45.52345
Northwest Tacoma | Washington | United States | ... | 231 | 0 | 0 | 0 | NCT00605475 | 1COMPLETED | 2010-09-01 | 2007-12-01 | Novartis | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 51 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated time on study treatment was until disease progress... | null | Liver Cancer | null | 1 | arm 1: Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity. | [
0
] | 2 | [
0,
0
] | intervention 1: 5 mg/kg iv on day 1 of each 2 week cycle. intervention 2: 150 mg orally (po) daily. | intervention 1: bevacizumab (Avastin) intervention 2: erlotinib (Tarceva) | 6 | Manila | N/A | Philippines | 120.9822 | 14.6042
Seoul | N/A | South Korea | 126.9784 | 37.566
Kueishan | N/A | Taiwan | N/A | N/A
Tainan City | N/A | Taiwan | 120.21333 | 22.99083
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.05306 | 51 | 0 | 0 | 0 | NCT00605722 | 1COMPLETED | 2010-09-01 | 2008-03-01 | Hoffmann-La Roche | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 26 | RANDOMIZED | FACTORIAL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | Caudal epidural analgesia (caudal block) is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have seconda... | null | Inguinal Herniorrhaphy Orchiopexy | Caudal Epidural Ropivacaine | null | 3 | arm 1: Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision. arm 2: Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:2... | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine intervention 2: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine intervention 3: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site | intervention 1: Ropivacaine intervention 2: Ropivacaine intervention 3: Ropivacaine | 1 | Loma Linda | California | United States | -117.26115 | 34.04835 | 0 | 0 | 0 | 0 | NCT00616577 | 6TERMINATED | 2010-09-01 | 2007-10-01 | Loma Linda University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 1 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA):
* Healthy lifestyle instruction (nutritional and physical activity surveillance and advice) + cont... | The proposed pilot study is being conducted to obtain pilot data to support a grant application for a multi-site randomized controlled trial. The primary objective is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents o... | Weight Gain | antipsychotic metformin children adolescents | null | 3 | arm 1: metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. arm 2: Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors arm 3: Self-selected patients will be followed at major ti... | [
0,
0,
4
] | 2 | [
0,
5
] | intervention 1: open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID intervention 2: additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors. | intervention 1: metformin intervention 2: healthy lifestyle intervention | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 1 | 0 | 0 | 0 | NCT00617058 | 6TERMINATED | 2010-09-01 | 2007-03-01 | University of North Carolina, Chapel Hill | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 101 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed. | This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM... | Bipolar I Disorder | Bipolar | null | 3 | arm 1: Participants who received olanzapine 5-20 mg/day in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks. arm 2: Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks. arm 3: Participants who did not particip... | [
0,
0,
0
] | 1 | [
0
] | intervention 1: 5-20 mg/day, oral, daily | intervention 1: Olanzapine | 10 | Aichi | N/A | Japan | 130.62158 | 32.51879
Chiba | N/A | Japan | 140.11667 | 35.6
Hiroshima | N/A | Japan | 132.45 | 34.4
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Kyoto | N/A | Japan | 135.75385 | 35.02107
Numakunai | N/A | Japan | 141.21667 | 39.96667
Saitama | N/A | Japan | 139.65657 | 35.90807
Shiga | N/A | Jap... | 101 | 0 | 0 | 0 | NCT00618748 | 1COMPLETED | 2010-09-01 | 2008-02-01 | Eli Lilly and Company | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 29 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | Adverse drug-drug interactions (DDIs) are responsible for approximately 3% of all hospitalizations in the US, perhaps costing more than $1.3 billion per year. One of the most common causes of DDIs is the when one drug alters the metabolism of another. A key enzyme in the liver and intestine, called "cytochrome P450 3A4... | null | Adverse Drug Interactions | drug interactions cytochrome P4503A4 Pregnane X-receptor induction drug metabolism | null | 3 | arm 1: Subjects are given 300 mg / 7 days of rifampicin to induce CYP3A4. Midazolam clearance is measured on the 8th day. arm 2: Sulforaphane (SFN), a natural product derived from broccoli sprouts, is utilized as a putative inhibitor of ligand (Rifampin) activation of the Pregnane X-receptor. In this arm, both SFN (put... | [
1,
1,
1
] | 3 | [
0,
7,
7
] | intervention 1: Rifampicin, an antibiotic used to treat TB, is administered at a dose of 300 mg day x 7 days to induce CYP3A5. intervention 2: Sulforaphane (SFN) is an isothiocyanate derived from the plant phytochemical, glucoraphinin. It appears to inhibit ligand binding to the ligand activated nuclear transcription f... | intervention 1: Rifampicin intervention 2: sulforaphane plus rifampicin intervention 3: sulforaphane alone | 2 | Seattle | Washington | United States | -122.33207 | 47.60621
Seattle | Washington | United States | -122.33207 | 47.60621 | 29 | 0 | 0 | 0 | NCT00621309 | 1COMPLETED | 2010-09-01 | 2008-03-01 | University of Washington | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 43 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism. NAC is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-ox... | null | Autistic Disorder | null | 2 | arm 1: active compound N-Acetyl Cysteine arm 2: Placebo or sugar pill | [
1,
2
] | 2 | [
0,
10
] | intervention 1: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 weeks Phase 3: Oral, 900 mg three times daily for 4 weeks
Entire intervention lasts for 12 weeks (drug administration is continuous). intervention 2: Phase 1: Oral, 900 mg daily for 4 weeks Phase 2: Oral, 900 mg twice daily 4 w... | intervention 1: N-Acetyl Cysteine intervention 2: Placebo - sugar pill | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 29 | 0 | 0 | 0 | NCT00627705 | 1COMPLETED | 2010-09-01 | 2008-02-01 | Stanford University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 63 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study; however, progression-free survival will be followed and determined for the patients in this study. Approximately 50 patients are planned to be enrolled in this study. | Given the favorable activity demonstrated in a trial using the taxane docetaxel in combination with cyclophosphamide, we propose a Phase II trial of 4 cycles of weekly nab paclitaxel combined with cyclophosphamide. The favorable toxicity profile for weekly nab paclitaxel, in addition to its demonstrated superiority ove... | Breast Cancer | Early Stage Breast Cancer Her2-positive nab paclitaxel cyclophosphamide trastuzumab | null | 1 | arm 1: 100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) in combination with 600 mg/m2 of IV cyclophosphamide once every 3 weeks for 4 cycles (i.e., a total treatment period of 12 weeks \[84 days\]). Patients with fluorescence in situ hybridization (FISH) HE... | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle) intervention 2: 600 mg/m2 of IV cyclophosphamide intervention 3: 8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 ... | intervention 1: nab paclitaxel intervention 2: Cyclophosphamide intervention 3: Trastuzumab | 10 | Lakeland | Florida | United States | -81.9498 | 28.03947
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Louisville | Kentucky | United States | -85.75941 | 38.25424
Portland | Maine | United States | -70.2589 | 43.65737
Bethesda | Maryland | United States | -77.10026 | 38.98067
Grand Rapids | Michigan ... | 63 | 0 | 0 | 0 | NCT00629499 | 1COMPLETED | 2010-09-01 | 2008-04-01 | SCRI Development Innovations, LLC | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 62 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | false | 0ALL | true | Prospective, randomized, controlled trial to test if post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC. | To test the hypothesis that probiotics will decrease the risk of post pull-through enterocolitis by randomizing patients to receive either probiotics or placebo for the first 3 months after surgical treatment for HD.
E.1. Design: This study will be a prospectively performed, multi-center, double blinded, study drug ve... | Hirschsprung Disease | Hirschsprung disease enterocolitis probiotics | null | 2 | arm 1: VSL#3 probiotic arm 2: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (4 sachets) of placebo will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (2 sachets) daily in the same amount of formula or breast... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Dosing will be based on patient weight. For those infants greater or equal to 5 kg, one gram (360 billion bacteria or 4 sachets) of VSL#3 will be administered into 3 ounces of either expressed breast milk or formula daily. For patients under 5 kg, 0.5 gm (180 billion bacteria or 2 sachets) daily in the ... | intervention 1: VSL#3 intervention 2: Placebo | 2 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Buffalo | New York | United States | -78.87837 | 42.88645 | 60 | 0 | 0 | 0 | NCT00630838 | 1COMPLETED | 2010-09-01 | 2006-09-01 | University of Michigan | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 1,695 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v. | This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who receive i.v. HX575 epoetin alfa treatment and to monitor the adverse event (AE) profile under post-approval conditions. | Chronic Kidney Disease | CKD subjects with or without dialysis treatment | null | 1 | arm 1: This post-authorization safety study was designed as a multi-center, multinational, prospective, single-arm clinical study with a 6-month HX575 (recombinant human) erythropoietin alfa treatment period. It was planned to include approximately 1,500 patients. | [
0
] | 1 | [
0
] | intervention 1: HX575 epoetin alfa i.v. will be administered according to the SmPC | intervention 1: HX575 recombinant human erythropoietin alfa | 114 | Bad Ischl | N/A | Austria | 13.61893 | 47.71109
Feldkirch | N/A | Austria | 9.6 | 47.23306
Freistadt | N/A | Austria | 14.50453 | 48.51103
Rohrbach | N/A | Austria | 14.35055 | 48.2165
Vienna | N/A | Austria | 16.37208 | 48.20849
Gabrovo | N/A | Bulgaria | 25.33417 | 42.87472
Karlovo | N/A | Bulgaria | 24.8 | 42.63333
... | 1,695 | 0 | 0 | 0 | NCT00632125 | 1COMPLETED | 2010-09-01 | 2008-07-01 | Sandoz | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 29 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | true | The primary objective of the proposed pilot study is to determine the efficacy of pregabalin in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients with neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, o... | Subjects were randomized into one of two treatment sequences: pregabalin/active placebo or active placebo/pregabalin. Each arm lasted 10 days, with a washout period of 10 days between treatments. Pregabalin was administered as a standardized two step titration, starting at 75mg twice daily up to a maximum daily dose of... | Lumbar Spinal Stenosis | Neurogenic claudication, lumbar spinal stenosis, treadmill testing | null | 2 | arm 1: Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days; no drug for 7 days; diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine red... | [
5,
5
] | 2 | [
0,
0
] | intervention 1: Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days. intervention 2: diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramin... | intervention 1: Pregabalin intervention 2: Diphenhydramine | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 52 | 0 | 0 | 0 | NCT00638443 | 1COMPLETED | 2010-09-01 | 2008-03-01 | University of Rochester | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
0
] | 23 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the... | null | Breast Cancer | newly diagnosed breast cancer neoadjuvant therapy | null | 1 | arm 1: The study will be conducted in 3 sequential treatment segments. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks. intervention 2: sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of suniti... | intervention 1: sunitinib alone intervention 2: sunitinib plus paclitaxel intervention 3: doxorubicin and cyclophosphamide | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 62 | 0 | 0 | 0 | NCT00656669 | 1COMPLETED | 2010-09-01 | 2008-04-01 | Indiana University | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 6 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Thalassemia intermedia (TI) is an inherited blood disorder that can cause anemia due to low levels of hemoglobin. Decitabine is a medication that may be effective at increasing hemoglobin levels. This study will evaluate the safety and effectiveness of decitabine at increasing hemoglobin levels in people with TI. | Thalassemias are inherited blood disorders that are characterized by low levels of hemoglobin and healthy red blood cells, which can lead to anemia. There are many different types of thalassemias, and TI is one type. People with TI often have moderate to severe anemia and may have a shortened life span, organ damage, a... | Thalassemia | Thalassemia Intermedia | null | 1 | arm 1: Participants will receive injected decitabine for 12 weeks. | [
0
] | 1 | [
0
] | intervention 1: Participants will receive 0.2 mg/kg of decitabine subcutaneously twice a week for 12 weeks. The dose will be reduced for toxicities as needed. The maximum dose of decitabine to be given will be 0.2 mg/kg. | intervention 1: Decitabine (USAN, INN) | 3 | Oakland | California | United States | -122.2708 | 37.80437
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Toronto | N/A | Canada | -79.39864 | 43.70643 | 5 | 0 | 0 | 0 | NCT00661726 | 1COMPLETED | 2010-09-01 | 2008-01-01 | Carelon Research | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 71 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients | null | Unresectable or Metastatic Colorectal Cancer | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: FOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. intervention 2: 37.5mg daily P.O., 4 weeks On 2weeks Off each... | intervention 1: FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil) intervention 2: Sunitinib | 10 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Chiba | Chiba | Japan | 140.11667 | 35.6
Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Sapporo | Hokkaido | Japan | 141.35 | 43.06667
Minoh/Osaka | Japan | Japan | N/A | N/A
Kochi | Kochi | Japan | 133.53333 | 33.55
Saku | Nagano | Japan | 138.48333 | 36.21667
Osakas... | 71 | 0 | 0 | 0 | NCT00668863 | 1COMPLETED | 2010-09-01 | 2008-05-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
0
] | 1 | NON_RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the pot... | null | Constipation Parkinson's Disease | Constipation Parkinson's Disease | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Lubiprostone 24 mcg BID orally for 4 weeks | intervention 1: Lubiprostone | 1 | Little Rock | Arkansas | United States | -92.28959 | 34.74648 | 1 | 0 | 0 | 0 | NCT00669461 | 6TERMINATED | 2010-09-01 | 2009-06-01 | University of Arkansas | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3,
4
] | 361 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries. | null | Malaria, Falciparum | P. Falciparum Malaria drug treatment clinical trial | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Combination of Azithromycin plus Chloroquine Azithromycin (\~30 mg/kg) + chloroquine (\~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) intervention 2: Artemether-lumefant... | intervention 1: Azithromycin plus Chloroquine intervention 2: Artemether-lumefantrine | 7 | Nouna | N/A | Burkina Faso | -3.86305 | 12.72939
Ouagadougou | N/A | Burkina Faso | -1.53388 | 12.36566
Abidjan | N/A | Côte d’Ivoire | -4.00167 | 5.35444
Navrongo | N/A | Ghana | -1.09083 | 10.89469
Kisumu | N/A | Kenya | 34.76171 | -0.10221
Bamako | West Africa | Mali | -7.97522 | 12.60915
Sikasso | West Africa | Mal... | 361 | 0 | 0 | 0 | NCT00677833 | 1COMPLETED | 2010-09-01 | 2008-06-01 | Pfizer | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
2
] | 9 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization. | This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization ... | Corneal Neovascularization | null | 1 | arm 1: 10 Patients will receive treatment (Ranibizumab) | [
0
] | 1 | [
0
] | intervention 1: 10 Patients will receive treatment (Ranibizumab) | intervention 1: Ranibizumab | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 9 | 0 | 0 | 0 | NCT00681889 | 1COMPLETED | 2010-09-01 | 2008-04-01 | Reza Dana, MD | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 23 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | This study will evaluate the effectiveness of the antipsychotic medication olanzapine in treating outpatients with anorexia nervosa. | Anorexia nervosa (AN) is a disease of disordered eating and is characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. Symptoms and behaviors of AN may include distorted body image, obsessive exercise, lack of menstruation among women, binge and purge eating behaviors, and int... | Eating Disorders | Anorexia Nervosa | null | 2 | arm 1: Participants will take olanzapine. arm 2: Participants will take matched placebo. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of olanzapine once each evening for 8 weeks. intervention 2: Participants will take 2.5 mg, 5.0 mg, or 10.0 mg of placebo once each evening for 8 weeks. | intervention 1: Olanzapine intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 23 | 0 | 0 | 0 | NCT00692185 | 1COMPLETED | 2010-09-01 | 2005-10-01 | New York State Psychiatric Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 75 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 1FEMALE | false | The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).
Secondly the objectives are to investigate any differences in patient reported outcomes be... | null | Back Pain | Postmenopausal women Back pain Osteoporosis related fracture | null | 2 | arm 1: PTH (1-84) + placebo alendronate arm 2: PTH (1-84) placebo + alendronate | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 100 µg PTH(1-84) daily intervention 2: 70 mg alendronate weekly | intervention 1: Parathyroid hormone (PTH) (1-84) intervention 2: Alendronate | 1 | Roskilde | N/A | Denmark | 12.08035 | 55.64152 | 75 | 0 | 0 | 0 | NCT00713258 | 6TERMINATED | 2010-09-01 | 2008-04-01 | Nycomed | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 222 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion. | null | Multiple Myeloma | null | 2 | arm 1: VELCADE administered by subcutaneous injection arm 2: VELCADE administered by intravenous infusion | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Patients will receive a 1.3mg/meters(squared)/dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle intervention 2: Patients will receive a 1.3mg/meters(squared) dose of VELCADE on Days 1,4,8, and 11 of a 3-week cycle. | intervention 1: VELCADE Administered by subcutaneous injection intervention 2: VELCADE Administered by intravenous infusion | 3 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Nantes | N/A | France | -1.55336 | 47.21725
Münster | N/A | Germany | 7.62571 | 51.96236 | 221 | 0 | 0 | 0 | NCT00722566 | 1COMPLETED | 2010-09-01 | 2008-07-01 | Millennium Pharmaceuticals, Inc. | 4INDUSTRY | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
[
3
] | 16 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how well it works in treating patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leuke... | OBJECTIVES:
Primary
* To determine the antitumor activity of panobinostat, in terms of objective response rate, time to progression, and survival, in patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.
* To assess the toxicity of panobinostat in these patients.
Secondary
* T... | Leukemia | Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia | null | 1 | arm 1: Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle | [
0
] | 4 | [
0,
6,
6,
10
] | intervention 1: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle intervention 2: Day 1 and day 28 samples intervention 3: Day 1 and day 28 samples intervention 4: Day 1 and day 28 samples | intervention 1: panobinostat intervention 2: gene expression analysis intervention 3: reverse transcriptase-polymerase chain reaction intervention 4: laboratory biomarker analysis | 2 | Duarte | California | United States | -117.97729 | 34.13945
Pasadena | California | United States | -118.14452 | 34.14778 | 16 | 0 | 0 | 0 | NCT00723203 | 6TERMINATED | 2010-09-01 | 2008-04-01 | City of Hope Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
5
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS. | Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be... | HIV Infections Fatigue | HIV AIDS Armodafinil Depression | null | 2 | arm 1: Participants will take armodafinil for 4 weeks. The dose will be titrated up from 50mg to 250mg per day as clinically indicated, using 50mg tablets. If responsive, participants will be offered 12 additional weeks of armodafinil. arm 2: Participants will receive placebo pills for 4 weeks. Placebo tablets that mat... | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated. intervention 2: Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy | intervention 1: Armodafinil intervention 2: Placebo | 1 | New York | New York | United States | -74.00597 | 40.71427 | 70 | 0 | 0 | 0 | NCT00737204 | 1COMPLETED | 2010-09-01 | 2008-06-01 | New York State Psychiatric Institute | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
3
] | 18 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | false | The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia (trouble sleeping); however; ramelteon has not bee... | Sleep has played an important role in migraine. Younger migraine sufferers usually report relief of migraine after sleep. In older migraine sufferers migraine is sometimes triggered with sleep changes. Occurrence of migraine in the early morning is very common. Therefore in these individuals regulation of sleep may imp... | Migraine Migraine With Aura Migraine Without Aura | Migraine Headache | null | 2 | arm 1: Ramelteon once daily (double-blind assignment) arm 2: Placebo tablet, once daily (double-blind assignment) | [
1,
2
] | 2 | [
0,
0
] | intervention 1: 8 mg tablet, oral, once daily intervention 2: Placebo tablet, oral, once daily | intervention 1: Ramelteon intervention 2: Placebo | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 13 | 0 | 0 | 0 | NCT00739024 | 6TERMINATED | 2010-09-01 | 2008-04-01 | Swedish Medical Center | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[
4
] | 25 | NON_RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | true | 1FEMALE | true | The mechanism for increased androgen production in women with polycystic ovary syndrome (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators hypothesize that in PCOS women ovarian theca cells, w... | Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research Center (GCRC) for study on 5 occasions. All subjects will receive an intravenous injection of hCG dose of 1, 10, 25, 100, and 250 micrograms, each of which will be given on one of 5 different days each separated by at least two ... | Polycystic Ovary Syndrome | polycystic ovary syndrome androgens ovary LH | null | 2 | arm 1: Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions. arm 2: Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions... | [
1,
1
] | 1 | [
0
] | intervention 1: Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions. | intervention 1: recombinant human chorionic gonadotropin | 1 | La Jolla | California | United States | -117.2742 | 32.84727 | 25 | 0 | 0 | 0 | NCT00747617 | 1COMPLETED | 2010-09-01 | 2007-09-01 | University of California, San Diego | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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