ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00471328
Conditions: Gastrointestinal Stromal Tumors
Keywords: GIST adults imatinib resistant sunitinib resistant AMN107 nilotinib treatment Gastrointestinal stromal tumor (GIST)
Sponsor: Novartis Pharmaceuticals
Start date: 2007-03-01; Completion date: 2011-06-01
Enrollment: 248 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.

Detailed description:

Arms: arm 1: 400mg twice daily in core and extension phases of the study. arm 2: In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.

Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression.
Interventions: intervention 1: Nilotinib intervention 2: Best Supportive Care (BSC) +/- imatinib or sunitinib
Intervention descriptions: intervention 1: Nilotinib 400 mg twice daily (bid) intervention 2: Can include pain medication, localized radiotherapy, nutritional support, and/or oxygen therapy and blood transfusions. Imatinib or sunitinib can be administered at the last tolerated dose and regimen or at the Investigator's choice.

Protocol documents:
Clinical trial NCT00555321
Conditions: Immunosuppression in Solid Organ Transplant
Sponsor: Bristol-Myers Squibb
Start date: 2008-01-01; Completion date: 2011-06-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: Other arm 5: None
Interventions: intervention 1: Tacrolimus intervention 2: Basiliximab intervention 3: Belatacept More Intensive (MI) intervention 4: Belatacept Less Intensive (LI) intervention 5: Mycophenolate Mofetil (MMF)
Intervention descriptions: intervention 1: Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\]) intervention 2: Intravenous (IV), 20 mg, Day1 and Day 5 intervention 3: Intravenous (IV),

10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24.

After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\]) intervention 4: Intravenous (IV),

10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12.

After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE) intervention 5: Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])

Protocol documents:
Clinical trial NCT00620542
Conditions: Coronary Atherosclerosis
Keywords: Coronary artery disease
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2011-06-01
Enrollment: 2333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.

Detailed description:

Arms: arm 1: Rosuvastatin 20 mg distributed in 2-week run-in period arm 2: Atorvastatin 40 mg distributed in 2-week run-in period arm 3: Rosuvastatin 40 mg distributed in core 2-year study arm 4: Atorvastatin 80 mg distributed in core 2-year study
Interventions: intervention 1: Rosuvastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: capsule, oral, once daily intervention 2: capsule, oral, one daily

Protocol documents:
Clinical trial NCT00662649
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis. Relapse-remitting Fingolimod
Sponsor: Novartis
Start date: 2008-02-01; Completion date: 2011-06-01
Enrollment: 920 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).

Detailed description:

Arms: arm 1: Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study. arm 2: Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study. arm 3: Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study. arm 4: Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study. arm 5: Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study.
Interventions: intervention 1: Fingolimod 0.5 mg intervention 2: Fingolimod 1.25 mg
Intervention descriptions: intervention 1: Patients self-administered fingolimod 0.5 mg capsules orally once daily. intervention 2: Patients self-administered fingolimod 1.25 mg capsules orally once daily.

Protocol documents:
Clinical trial NCT00704847
Conditions: Osteoarthritis
Keywords: Osteoarthritis, oral salmon calcitonin, treatment, efficacy, tolerability
Sponsor: Nordic Bioscience A/S
Start date: 2008-06-01; Completion date: 2011-06-01
Enrollment: 1030 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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

Detailed description:

Arms: arm 1: SMC021 Oral Calcitonin arm 2: SMC021 Placebo
Interventions: intervention 1: Oral Salmon Calcitonin intervention 2: Oral Salmon Calcitonin (Placebo)
Intervention descriptions: intervention 1: 0.8mg SMC021, twice daily intervention 2: 0.8mg Placebo, twice daily

Protocol documents:
Clinical trial NCT01061723
Conditions: Ankylosing Spondylitis
Sponsor: Sanofi
Start date: 2010-02-01; Completion date: 2011-06-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

\- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)

Secondary objectives:

* to demonstrate that Sarilumab was effective on:

  * assessment of higher level of response \[ASAS 40% response criteria (ASAS40)\]
  * partial remission
  * disease activity
  * range of motion
  * Magnetic Resonance Imaging (MRI) of the spine
* to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS

Detailed description:
The duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.

Arms: arm 1: Placebo (for sarilumab) weekly (qw) for 12 weeks. arm 2: Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks. arm 3: Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. arm 4: Sarilumab 100 mg SC injection qw for 12 weeks. arm 5: Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. arm 6: Sarilumab 150 mg SC injection qw for 12 weeks.
Interventions: intervention 1: Sarilumab intervention 2: Placebo
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous intervention 2: Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Protocol documents:
Clinical trial NCT01122264
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Start date: 2010-05-01; Completion date: 2011-06-01
Enrollment: 770 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

Detailed description:

Arms: arm 1: 10 milligrams (mg) or 20 mg on demand arm 2: 5 mg or 2.5 mg once a day arm 3: 50 mg, 100 mg, or 25 mg on demand
Interventions: intervention 1: Tadalafil intervention 2: Sildenafil Citrate
Intervention descriptions: intervention 1: Administered orally for 24 weeks. intervention 2: Administered orally for 24 weeks.

Protocol documents:
Clinical trial NCT00086684
Conditions: Interstitial Cystitis
Keywords: Interstitial Cystitis Urinary Bladder Pain
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2003-09-01; Completion date: 2011-06-01
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.

Detailed description:
The purpose of this multi-center, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the effectiveness and safety of two doses of pentosan polysulfate sodium (100 mg once a day and 100 mg three times a day) versus placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis. The hypothesis of the study is that there is no treatment difference in the proportion of responders at study endpoint (Week 24). Effectiveness will be assessed based on the reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) total score. Safety assessments include vital signs, laboratory tests, adverse events and physical exams. Patients will receive one of the following study treatments by mouth each day for 24 weeks: pentosan polysulfate sodium 100 mg once a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, and one matching placebo capsule in the afternoon and evening; pentosan polysulfate sodium 100 mg capsule three times a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, afternoon and evening; placebo group - one placebo capsule in the morning, afternoon and evening

Arms: arm 1: One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks arm 2: One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks arm 3: Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks
Interventions: intervention 1: Pentosan polysulfate sodium 100 mg intervention 2: Placebo intervention 3: Pentosan polysulfate sodium 100 mg
Intervention descriptions: intervention 1: One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks intervention 2: One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks intervention 3: One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks

Protocol documents:
Clinical trial NCT00103376
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer
Sponsor: Medical University of South Carolina
Start date: 2004-10-01; Completion date: 2011-06-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Giving bortezomib with hormone therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone therapy works in treating patients with relapsed prostate cancer.

Detailed description:

Arms: arm 1: Patient will complete Part A (Velcade only). If the patient has a complete response, he will come off study. If the patient has progressive disease, he will start Part B (Velcade + antiandrogen). If the patient has a partial response or stable disease, he will start Part B after at least a 7-day break. arm 2: Patient will start Part B after completing Part A or may be enrolled to part B only.
Interventions: intervention 1: Velcade intervention 2: LH-RH Agonist intervention 3: Androgen Receptor Antagonists
Intervention descriptions: intervention 1: Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.

Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break intervention 2: given as a 3 month depo-injection intervention 3: given orally daily for 3 months

Protocol documents:
Clinical trial NCT00140244
Conditions: HAART-induced Lipodystrophy and Metabolic Syndrome
Keywords: leptin lipodystrophy insulin resistance hyperlipidemia metabolic syndrome
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2001-12-01; Completion date: 2011-06-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.

Detailed description:
Exposure to HIV medications has been associated with metabolic changes including generalized fat depletion (lipoatrophy), high triglyceride levels, and in some patients, high sugar levels or diabetes. This syndrome is associated with a deficiency of leptin, a hormone produced by fat cells. Recent studies involving leptin administration to patients with congenital lipoatrophy have shown dramatic improvements in metabolic parameters such as insulin resistance and hyperlipidemia. Leptin administration to patients with HAART-induced lipoatrophy may also lead to significant improvements in the metabolic abnormalities found in these HIV+ patients. The aims of this study are to examine the effect of leptin administration on insulin resistance and other parameters of the metabolic syndrome in HIV patients with HAART-induced lipoatrophy.

Comparison: Leptin-treated group to placebo-treated group

Arms: arm 1: r-MetHuLeptin SubQ once daily arm 2: SubQ once daily
Interventions: intervention 1: r-metHuLeptin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00201773
Conditions: Breast Cancer
Keywords: Post-Menopause Neoadjuvant Therapy
Sponsor: Ohio State University Comprehensive Cancer Center
Start date: 2003-07-01; Completion date: 2011-06-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To test whether the addition of the COX-2 inhibitor, celecoxib, will decrease the gene expression of CYP19 in breast cancers collected from postmenopausal women that receive neoadjuvant exemestane.

Detailed description:
Rationale: In postmenopausal women, the main source of estrogen is through the conversion of androgens, or sex hormones produced by the adrenal glands. An enzyme called aromatase carries out this process. Exemestane, an aromatase inhibitor, blocks production of estrogens. Research indicates that the gene responsible for aromatase activity is CYPO19. Therefore, exemestane helps to inhibit aromatase activity through CYP019. Along with CYP019, another gene associated with breast cancer is an overexpression of COX-2 enzymes. Research suggests that COX-2 overexpression can cause cancer cell division, increased blood flow to tumors, and metastases. Celecoxib blocks COX-2 activity and produces fewer side effects compared with other non-steroidal inflammatory drugs (NSAIDs). This study builds on previous research to test the combination of exemestane and celecoxib for breast cancer.

Purpose: This study is evaluating the safety and efficacy of exemestane and celecoxib before surgery for stage II, III, and IV breast cancer in postmenopausal women. Tests will analyze the CYP019 gene after these treatments.

Treatment: Patients in this study will receive exemestane and celecoxib. Both drugs will be given to patients as oral pills. Exemestane will be taken daily for sixteen weeks. Starting in week 9, celecoxib will be taken twice daily for eight weeks. Therefore, during weeks 9-16, patients will be taking both exemestane and celecoxib. Several tests and exams will be given throughout the study to closely monitor patients, including a biopsy performed after the first 8 weeks on exemestane. After sixteen weeks on exemestane and celecoxib, patients will have breast surgery.

Arms: arm 1: Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.
Interventions: intervention 1: Exemestane intervention 2: Celecoxib intervention 3: Correlative studies
Intervention descriptions: intervention 1: 25 mg orally once per day for 16 weeks. intervention 2: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food. intervention 3: None

Protocol documents:
Clinical trial NCT00246571
Conditions: Breast Neoplasms
Sponsor: Pfizer
Start date: 2006-01-01; Completion date: 2011-06-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare progression free survival for SU011248 \[sutent (sunitinib malate)\] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SU011248 intervention 2: Chemotherapy
Intervention descriptions: intervention 1: SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit. intervention 2: The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.

1. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
2. Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
3. Docetaxel - 75-100 mg/m2 every 3 weeks
4. Paclitaxel - 175-200 mg/m2 every 3 weeks
5. Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
6. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248.

Protocol documents:
Clinical trial NCT00296725
Conditions: Major Depression Dysthymia Depressive Disorder Not Otherwise Specified
Keywords: Major Depression Dysthymia Depression Not Otherwise Specified Dichotic Listening Fluoxetine Imipramine Predictors
Sponsor: New York State Psychiatric Institute
Start date: 1994-04-01; Completion date: 2011-06-01
Enrollment: 25 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
Depressed patients will have hearing tests and then be treated with up to three treatments (i.e., Fluoxetine, Imipramine) until remitted, to see whether test results predict specific outcomes.

Detailed description:
100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with Fluoxetine and Imipramine until remitted. Preferential hemisphere for auditory processing will be correlated with treatment outcome.

Arms: arm 1: fluoxetine or Imipramine
Interventions: intervention 1: Fluoxetine intervention 2: Imipramine
Intervention descriptions: intervention 1: Phase 1: Fluoxetine: wk 1: 10 mg/day; wks 2-3: 20 mg/day; wks 4-5: 40 mg/day; wk 6: 60 mg/day; wks 7-12: 80 mg/day \*All increases only if tolerated. intervention 2: Phase 2: Imipramine wk 1: 25 mg/day; wk 2: 50 mg/day; wk 3: 100 mg/day, 150 mg/day after 3 days; wk 4: 200 mg/day, 250 mg/day after 3 days; wks 5-6: 300 mg/day. \*All increases only if tolerated.

Protocol documents:
Clinical trial NCT00303108
Conditions: Metastatic Breast Cancer
Sponsor: US Oncology Research
Start date: 2005-12-01; Completion date: 2011-06-01
Enrollment: 136 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).

Detailed description:

Arms: arm 1: Patients will receive IV Doxil 30 mg/m2 and carboplatin AUC=5 on Day 1 of each cycle. A cycle consists of 28 days. In addition, HER2+ (IHC3+ and FISH+) patients only will receive a one-time loading dose of Herceptin 8 mg/kg IV on Day 1 of Cycle 1 and 4 mg/kg on Day 1 and Day 15 of every cycle thereafter.
Interventions: intervention 1: Pegylated liposomal doxorubicin intervention 2: Carboplatin intervention 3: trastuzumab
Intervention descriptions: intervention 1: 30 mg/m2 IV on Day 1 of each 28 day cycle intervention 2: AUC=5 on Day 1 of each 28 day cycle intervention 3: 4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)

Protocol documents: