ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00415597
Conditions: Pain
Keywords: chronic pain joint pain back pain diabetic peripheral neuropathy post herpetic neuralgia ALO-01 Embeda Chronic Non-Malignant Pain
Sponsor: Pfizer
Start date: 2006-12-01; Completion date: 2008-03-01
Enrollment: 467 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.

Detailed description:

Arms: arm 1: Doses given once or twice daily
Interventions: intervention 1: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
Intervention descriptions: intervention 1: capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily

Protocol documents:
Clinical trial NCT00416195
Conditions: Epilepsy
Sponsor: Eisai Co., Ltd.
Start date: 2006-12-01; Completion date: 2008-03-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each. One group will be patients who take concomitant inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to a maximum of 12 mg per day) and six will receive placebo.

Detailed description:

Arms: arm 1: 2 mg E2007 once daily for 2 weeks (Days 1 to 14), then 4 mg E2007 once daily for 2 weeks (Days 15 to 28), then 6 mg E2007 once daily for 2 weeks (Days 29 to 42), then 8 mg E2007 once daily for 2 weeks (Days 43 to 56), then 10 mg E2007 once daily for 2 weeks (Days 57 to 70), then 12 mg E2007 once daily for 6 weeks (Days 71 to 112). arm 2: Matching placebo once daily for 16 weeks (Days 1 to 112)
Interventions: intervention 1: E2007 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00420004
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2006-12-01; Completion date: 2008-03-01
Enrollment: 469 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to assess the safety and effectiveness of LY2216684 compared to placebo in treating adults with major depressive disorder.

Detailed description:

Arms: arm 1: LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks.

For the first week of treatment, participants received a starting dose of 3 mg/day. Then, based on tolerability, for the next 7 weeks, the dose could remain at 3 mg/day; it could be increased 3 mg at a time (scheduled visit) to a maximum dose of 12 mg/day; or it could be decreased 3 mg at any time (scheduled or unscheduled visits) to a minimum dose of 3 mg/day.

All participants were required to take an equal number of tablets (2) and capsules (2) per day. Therefore, participants on 3 mg/day and 6 mg/day of LY2216684 also received 1 LY2216684-matching placebo tablet + 2 escitalopram-matching placebo capsules. Participants on 9 mg/day and 12 mg/day of LY2216684 also received 2 escitalopram-matching placebo capsules. arm 2: Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks. arm 3: Escitalopram: flexible dose of 10 or 20 milligram (mg), capsules, administered orally, once daily for 8 weeks.

For the first week of treatment, participants received a starting dose of 10 mg/day. Then, based on tolerability, for the next 7 weeks, the dose could remain at 10 mg/day; it could be increased up to a maximum dose of 20 mg/day; or it could be decreased back to 10 mg/day.

All participants were required to take an equal number of tablets (2) and capsules (2) per day. Therefore, participants on 10 mg/day of escitalopram also received 1 escitalopram-matching placebo capsule + 2 LY2216684-matching placebo tablets. Participants on 20 mg/day of escitalopram also received 2 LY2216684-matching placebo tablets.
Interventions: intervention 1: LY2216684 intervention 2: Placebo intervention 3: Escitalopram
Intervention descriptions: intervention 1: 3-mg and 6-mg tablets intervention 2: None intervention 3: 10-mg capsules

Protocol documents:
Clinical trial NCT00423579
Conditions: Hypercholesterolemia Coronary Disease
Sponsor: Organon and Co
Start date: 2006-07-01; Completion date: 2008-03-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.

Detailed description:

Arms: arm 1: Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment arm 2: Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
Interventions: intervention 1: Ezetimibe/Simvastatin 10/20 mg intervention 2: simvastatin 40 mg
Intervention descriptions: intervention 1: 1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks intervention 2: 1 tablet containing 40 mg of simvastatin per day for 6 weeks

Protocol documents:
Clinical trial NCT00425373
Conditions: Essential Hypertension
Keywords: Hypertension, Valsartan, Amlodipine, high blood pressure
Sponsor: Novartis Pharmaceuticals
Start date: 2006-11-01; Completion date: 2008-03-01
Enrollment: 1474 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None
Interventions: intervention 1: Valsartan + amlodipine 40/2.5 mg intervention 2: Valsartan + amlodipine 40/5 mg intervention 3: Valsartan + amlodipine 80/2.5 mg intervention 4: Valsartan + amlodipine 80/5 mg intervention 5: Valsartan 40 mg intervention 6: Valsartan 80 mg intervention 7: Amlodipine 2.5 mg intervention 8: Amlodipine 5 mg intervention 9: Placebo
Intervention descriptions: intervention 1: Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 2: Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 3: Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 4: Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 5: Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 6: Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily intervention 7: Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily intervention 8: Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily intervention 9: 4 tablet and 2 capsule placebos taken once daily

Protocol documents:
Clinical trial NCT00430937
Conditions: Skin Diseases, Infectious Soft Tissue Infections
Keywords: Complicated Skin and Soft Tissue Infections. Daptomycin, Vancomycin, Teicoplanin Complicated skin and soft tissue infections
Sponsor: Novartis Pharmaceuticals
Start date: 2006-04-01; Completion date: 2008-03-01
Enrollment: 194 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections

Detailed description:

Arms: arm 1: 4 mg/kg intravenous (i.v.) once daily arm 2: None
Interventions: intervention 1: Daptomycin intervention 2: Vancomycin intervention 3: Teicoplanin
Intervention descriptions: intervention 1: 4 mg/kg intravenous once daily intervention 2: 1 g intravenous twice daily intervention 3: 400 mg intravenous once daily following a loading dose of 400 mg administered at 0, 12, 24 hours on day one.

Protocol documents:
Clinical trial NCT00454051
Conditions: Asthma
Keywords: Asthma, anti-immunoglobulin E, omalizumab, IgE receptors
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2008-03-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.

Detailed description:
Double blind placebo controlled study to assess the expression of IgE on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week Omalizumab treatment.

Arms: arm 1: Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level. arm 2: Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
Interventions: intervention 1: Omalizumab intervention 2: placebo
Intervention descriptions: intervention 1: Omalizumab was supplied as a sterile, freeze dried preparation, to be reconstituted to deliver 150mg of omalizumab. Each vial was reconstituted with 1.4ml of sterile water for injection. The appropriate dose and dosing frequency of omalizumab were determined by baseline total IgE and body weight. A dosing table was used following the European Summary of Product Characteristics (SmPC) of omalizumab. intervention 2: Placebo was a physiological salt solution, administered according to the same administration scheme to respect the same dosing frequency and injected volume.

Protocol documents:
Clinical trial NCT00459667
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing multiple sclerosis interferon beta 1b Betaferon Betaseron
Sponsor: Bayer
Start date: 2007-05-01; Completion date: 2008-03-01
Enrollment: 1420 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

Detailed description:
Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.

Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)

Randomization: No randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.

The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.

Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.

Arms: arm 1: Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind) arm 2: Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind) arm 3: Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day

\*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)
Interventions: intervention 1: Interferon beta-1b (Betaseron, BAY86-5046) intervention 2: Interferon beta-1b (Betaseron, BAY86-5046) intervention 3: Interferon beta-1b (Betaseron, BAY86-5046)
Intervention descriptions: intervention 1: Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label). intervention 2: Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label). intervention 3: Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.

Phase B: All patients will receive 500µg s.c.every other day (open-label).

Protocol documents:
Clinical trial NCT00492024
Conditions: Sinusitis
Keywords: Respiratory Tract Infection Bacterial Sinusitis
Sponsor: Bayer
Start date: 2005-01-01; Completion date: 2008-03-01
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.

Detailed description:

Arms: arm 1: Moxifloxacin 400mg once daily for 5 days arm 2: Matching placebo for 5 days
Interventions: intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Placebo
Intervention descriptions: intervention 1: Moxifloxacin - 400 mg once a day for 5 days intervention 2: Placebo - 380 mg Microcrystalline Cellulose

Protocol documents:
Clinical trial NCT00496483
Conditions: Renal Failure
Keywords: Tacrolimus Pharmacokinetics Kidney Transplantation
Sponsor: Veloxis Pharmaceuticals
Start date: 2007-07-01; Completion date: 2008-03-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

Detailed description:
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

Stable kidney transplant patients who fulfill all I/E criteria will be enrolled and kept on Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf, all patients will be converted to once daily LCP-Tacro for 7 days with no dose changes allowed. On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will be converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53.

Arms: arm 1: Experimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
Interventions: intervention 1: LCP Tacro (tacrolimus) intervention 2: Prograf
Intervention descriptions: intervention 1: Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.

Other Names:

Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets. intervention 2: Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.

Other Names:

Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.

Protocol documents:
Clinical trial NCT00510484
Conditions: Cystic Fibrosis
Keywords: Pancreatic exocrine insufficiency Cystic Fibrosis
Sponsor: Solvay Pharmaceuticals
Start date: 2007-11-01; Completion date: 2008-03-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pancrelipase Delayed Release intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: 24000 unit Capsule intervention 2: Placebo

Protocol documents:
Clinical trial NCT00512798
Conditions: Brain and Central Nervous System Tumors Melanoma Solid Tumor
Keywords: stage III melanoma stage IV melanoma recurrent melanoma unspecified adult solid tumor, protocol specific recurrent adult brain tumor melanoma (skin)
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2003-06-01; Completion date: 2008-03-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temozolomide together with bortezomib may kill more tumor cells.

PURPOSE: To determine the best dose of bortezomib and temozolomide and to see how well they work in treating patients with advanced refractory solid tumors or melanoma.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PS-341 (VELCADE) intervention 2: temozolomide intervention 3: immunoenzyme technique intervention 4: PS-341 (VELCADE) intervention 5: Temozolomide
Intervention descriptions: intervention 1: Dose Levels PS-341 (day 1)

* Level -1 0.7 mg/m2
* Level 1 1.0 mg/m2
* Level 2 1.0 mg/m2
* Level 3 1.3 mg/m2
* Level 4 1.5 mg/m2 intervention 2: Temozolomide (day 8)

* Level - 1 50 mg/m2
* Level 1 50 mg/m2
* Level 2 75/mg/m2
* Level 3 75 mg/m2
* Level 4 75 mg/m2 intervention 3: Not noted intervention 4: 1.3 mg/m2 by IV on days 1, 4, 8, and 11 of every 21 days intervention 5: 75 mg/m2 by mouth, daily, during weeks 2-8 (42 days) of every 9-week course.

Protocol documents:
Clinical trial NCT00522301
Conditions: Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2007-07-01; Completion date: 2008-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: 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.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer in at least the second remission.

Detailed description:
OBJECTIVES:

Primary

* To determine the 12-month progression-free survival (PFS) rate of women with ovarian epithelial, fallopian tube, or peritoneal cancer in second or greater remission treated with oral sorafenib tosylate.

Secondary

* To determine the safety and tolerability of prolonged treatment with oral sorafenib tosylate in women with a history of recurrent ovarian cancer.
* To correlate serum markers of angiogenesis (i.e., VEGF and bFGF) and tumor markers pAKT, HIF-1 α , and VEGF with 12-month PFS.

OUTLINE: Patients receive oral sorafenib twice a day on days 1-28. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection at baseline, every 12 weeks during study, and after completion of study therapy for pharmacokinetic studies. Samples are analyzed for soluble markers of angiogenesis (i.e., VEGF and bFGF) via ELISA and HIF-1 α, VEGF, and pAKT via IHC staining.

After completion of study treatment, patients are followed at 4 weeks.

Arms: arm 1: Sorafenib is supplied as 200-mg tablets. Sorafenib will be administered as 400 mg orally daily x 28 days (continuous). One cycle = 28 days. There is no planned treatment interruption between cycles. Sorafenib should be taken without food (at least 1 hour before or 2 hours after eating). In the absence of intolerable toxicity, a patient may continue to receive treatment with sorafenib until disease progression, or until 24 months have elapsed.
Interventions: intervention 1: sorafenib tosylate intervention 2: immunoenzyme technique intervention 3: immunohistochemistry staining method intervention 4: laboratory biomarker analysis intervention 5: pharmacological study
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00522431
Conditions: Hypogonadism
Keywords: Hypogonadism
Sponsor: Endo Pharmaceuticals
Start date: 2007-08-01; Completion date: 2008-03-01
Enrollment: 149 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

Detailed description:

Arms: arm 1: 2% testosterone gel
Interventions: intervention 1: Testosterone
Intervention descriptions: intervention 1: 2% gel

Protocol documents: