ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00434148
Conditions: Cushing's Disease
Keywords: Cushing's Disease pasireotide SOM230
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2014-05-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.

Detailed description:

Arms: arm 1: At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was \<= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country. arm 2: At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was \<= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
Interventions: intervention 1: Pasireotide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00488982
Conditions: Prostate Cancer
Keywords: Metastatic Hormone Refractory Prostate Cancer
Sponsor: University of California, San Francisco
Start date: 2007-04-01; Completion date: 2014-05-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-arm, randomized Phase II study of intermittent chemotherapy with and without GM-CSF. All patients will receive six 21-day cycles of docetaxel 75 mg/m2 on Day 2 of each cycle and 5 mg prednisone twice a day on Days 1-21. Following six cycles of chemotherapy, eligible subjects will be randomized to no maintenance therapy or to maintenance GM-CSF therapy. The GM-CSF group dose schedule will be 250 mcg/m2 subcutaneous (SQ) daily Days 15-28 every 28 days. Patients in both groups will continue until disease progression at which time GM-CSF will be discontinued and chemotherapy will again be administered.

Detailed description:

Arms: arm 1: Intermittent docetaxel/prednisone with no maintenance therapy: Patients will discontinue docetaxel/prednisone and undergo observation until disease progression at which time they will re-initiate docetaxel/prednisone. Six cycles of docetaxel/prednisone will again be administered before subsequent discontinuation of chemotherapy arm 2: Intermittent docetaxel/prednisone with maintenance GM-CSF therapy: Patients will discontinue docetaxel/prednisone and will receive maintenance GM-CSF until disease progression at which time, they will discontinue GM-CSF and resume docetaxel/prednisone. Six cycles of docetaxel/prednisone will again be administered before discontinuation of chemotherapy and GM-CSF therapy is re-initiated. GM-CSF dose/schedule will be as previously described (250 mcg/m2 SQ daily, days 15-28 q28 days)
Interventions: intervention 1: Docetaxel intervention 2: Docetaxel and GM-CSF
Intervention descriptions: intervention 1: Docetaxel 75mg/m2 every 21 days intervention 2: Docetaxel 75mg/m2 every 21 days and GM-CSF 250mcg/m2 SQ days 15-28

Protocol documents:
Clinical trial NCT00574587
Conditions: Breast Cancer
Keywords: Vorinostat Neoadjuvant Chemotherapy
Sponsor: Albert Einstein College of Medicine
Start date: 2007-12-01; Completion date: 2014-05-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Vorinostat is a histone deacetylase (HDAC) inhibitor which is approved by the U.S. Food and Drug Administration for the treatment of a rare type of cancer involving the skin (cutaneous T cell lymphoma), but not for breast cancer. HDAC inhibitors work by unsilencing tumor suppressor genes and other genes in the cancer cells that are repressed; when the genes are turned back on by the drug, it leads to death of the cancer cells. HDAC inhibitors such as vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in experimental systems. The purpose of this trial is to determine the optimal dose of vorinostat to use in combination with standard chemotherapy alone (or in combination with plus trastuzumab for HER2-positive disease), and to determine whether vorinostat enhances the effectiveness of standard chemotherapy (+/- trastuzumab) in patients with locally advanced breast cancer.

Detailed description:
This is a phase I-II trial in which patients with stage IIB-IIIC breast cancer will receive:

1. Neoadjuvant weekly paclitaxel (80 mg/m2 IV weekly x 12 weeks) plus vorinostat (200 or 300 mg PO BID on days 1-3 each paclitaxel dose) and trastuzumab (4 mg/kg loading dose, 2 mg/kg IV weekly x 12 total doses if HER2 positive, followed by:
2. Doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 2 weeks x 4 cycles (plus G-CSF), followed by:
3. Surgery (lumpectomy or mastectomy)

Arms: arm 1: Vorinostat (PO days 1-3) plus weekly paclitaxel x 12 weeks (and trastuzumab if HER2-positive), followed by doxorubicin-cyclophosphamide every 2 weeks x 4 cycles, followed by surgery
Interventions: intervention 1: Vorinostat intervention 2: Paclitaxel intervention 3: Trastuzumab intervention 4: Doxorubicin intervention 5: Cyclophosphamide intervention 6: Surgery
Intervention descriptions: intervention 1: Vorinostat 200 or 300 mg PO BID on days 1-3 of each weekly paclitaxel dose intervention 2: Paclitaxel 80 mg/m2 weekly for 12 weeks intervention 3: Trastuzumab (if HER2-positive) 4 mg/kg, then 2 mg/kg weekly for 12 weeks including loading dose intervention 4: Doxorubicin 60 mg/m2 every 2 weeks for 8 weeks intervention 5: Cyclophosphamide 600 mg/m2 every 2 weeks for 8 weeks intervention 6: Surgical excision of tumor from breast

Protocol documents:
Clinical trial NCT00710034
Conditions: Tobacco Use Disorder
Keywords: Oral Tobacco Products Snus Smoking Substitution Harm Reduction Biomarkers of Tobacco Exposure
Sponsor: University of Minnesota
Start date: 2010-04-01; Completion date: 2014-05-01
Enrollment: 391 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.

For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.

Detailed description:
This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. The secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. Other secondary aim includes examining the effects of the two products on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).

Arms: arm 1: Nicotine replacement therapy (4 mg nicotine gum) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute nicotine gum for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12. arm 2: Oral tobacco (Camel Snus) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute snus for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.
Interventions: intervention 1: Oral tobacco intervention 2: Nicotine Gum
Intervention descriptions: intervention 1: Snus intervention 2: 4 mg Nicotine gum

Protocol documents:
Clinical trial NCT00741598
Conditions: Bipolar Disorder
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2008-09-01; Completion date: 2014-05-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine whether extended release galantamine, a drug approved by the Food and Drug Administration to reduce cognitive impairments in people with Alzheimer's disease, can perform the same function in stable people with bipolar disorder.

Detailed description:
Approximately 2.6% of Americans age 18 and older, or 5.7 million people, suffer from bipolar disorder. The manic and depressive episodes associated with bipolar disorder prevent normal functioning in individuals with the disorder, but functional impairment can occur even when bipolar disorder is in remission. Previous research indicates that this impairment in stable individuals with bipolar disorder is linked to neurocognitive deficits, such as problems with memory and attention. The drug extended release galantamine increases the level of acetylcholine, a neurotransmitter important for memory, available in the brain. This drug has already been approved by the FDA to treat neurocognitive impairment in Alzheimer's disease patients. This study will examine whether administering the drug to individuals with bipolar disorder who are in remission can also reduce their neurocognitive deficits and improve the quality of their life. The study will also examine the safety of the drug for use in the obsessive-compulsive disorder population.

Participation in this study will last about 18 weeks and will involve six study visits. Each of the first two visits will include 2 hours of clinical, physical, and self-report tests, the first for screening and the second to establish physical and mental health baseline measurements. Participants will then be randomly assigned to receive either galantamine or placebo daily for 16 weeks, and they will be provided with enough of the assigned pill to last until the next visit. Half hour visits on Weeks 4, 8, and 12 will consist of psychological self-report tests and interviews, clinical assessment of side effects from the drug, and the determination by the examining doctor and participant whether to increase, decrease, or maintain the same level of the drug. Participants will also be given enough of the drug to last until the next visit. The final visit, on Week 16, will last 2 hours and will consist of the same tests administered at the baseline visit in addition to the neuropsychological tests administered at the screening visit. The full range of tests will measure physical health, verbal memory, mental flexibility, attention, life impairment, and life satisfaction.

Arms: arm 1: Participants will receive treatment with extended release galantamine arm 2: Participants will receive treatment with placebo.
Interventions: intervention 1: Galantamine-ER intervention 2: Galantamine placebo
Intervention descriptions: intervention 1: Galantamine-ER 8 to 24 mg per day for 16 weeks intervention 2: Galantamine placebo 8 to 24 mg per day for 16 weeks

Protocol documents:
Clinical trial NCT00812253
Conditions: Congestive Heart Failure Diabetes Mellitus
Keywords: Heart failure Hyperglycemia Hospital Diabetes Mellitus
Sponsor: Kathleen Dungan
Start date: 2009-01-01; Completion date: 2014-05-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with heart failure often have high blood sugar (glucose).

Detailed description:
Patients with heart failure often have high blood sugar. High glucose contributes to severe hospital complications and even death. Studies suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. In this study, we will determine whether normalizing blood sugars using intravenous insulin short-term will improve outcomes in patients hospitalized for congestive heart failure. We enrolled patients with severe heart failure and randomly assigned them into 2 groups. We used intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections in group 2. We determined whether intravenous insulin improved hospital length of stay, rates of readmission, inflammatory markers, and cardiovascular tests that predict mortality in patients with heart failure.

Arms: arm 1: None arm 2: Basal bolus insulin (4 injections per day)
Interventions: intervention 1: Intravenous insulin intervention 2: Subcutaneous insulin
Intervention descriptions: intervention 1: Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day. intervention 2: Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Protocol documents:
Clinical trial NCT00841971
Conditions: Mycoses Fungemia Central Nervous System Fungal Infections Lung Diseases, Fungal
Sponsor: University of Pittsburgh
Start date: 2010-02-01; Completion date: 2014-05-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients

Detailed description:
A number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation.

Retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients.

Most Invasive fungal infections in these high-risk patients occur within the first month posttransplant.

Studies utilizing universal prophylaxis have primarily employed fluconazole. A recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans Candida spp. in patients receiving prophylaxis.

The availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. Anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. Anidulafungin has demonstrated good safety profile. We hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.

Arms: arm 1: anti-fungal agent arm 2: anti-fungal agent
Interventions: intervention 1: Anidulafungin intervention 2: Fluconazole
Intervention descriptions: intervention 1: 200 mg IV loading dose followed by 100 mg qd for 21 days intervention 2: 400 mg IV for 21 days

Protocol documents:
Clinical trial NCT00855439
Conditions: Type 2 Diabetes Mellitus Diabetic Peripheral Neuropathy
Keywords: Diabetes Neuropathy Glucose Control Peripheral Autonomic
Sponsor: University of Michigan
Start date: 2008-06-01; Completion date: 2014-05-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will look at whether or not the medication exenatide improves signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy.

Detailed description:
This study will look at the effects of the medication exenatide on peripheral neuropathy in people with type 2 diabetes. Exenatide (trade name, BYETTA®) is an injectable medication used by people with type 2 diabetes to control blood sugar. Peripheral neuropathy is a complication of diabetes that can cause symptoms such as numbness, tingling or burning sensations in the feet and hands. Controlling blood sugars levels in type 2 diabetes is thought to prevent, delay or improve the damage to the nerve fibers that causes peripheral neuropathy. There is also some evidence that exenatide may have additional beneficial effects on the peripheral nerves, beyond the benefits of blood sugar control alone. In this study, about half of the participants will take exenatide by injection twice daily and the other half will take insulin glargine (Lantus®) by injection once daily. Both groups are expected to have similar improvement in blood sugar control. This study will show whether exenatide has beneficial effects on neuropathy beyond the benefits of better blood sugar control alone.

Arms: arm 1: Subjects will take exenatide by subcutaneous injection twice daily for 18 months arm 2: Subjects will take 1 daily injection of insulin glargine for 18 months.
Interventions: intervention 1: Exenatide intervention 2: Glargine
Intervention descriptions: intervention 1: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels intervention 2: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control

Protocol documents:
Clinical trial NCT00865124
Conditions: Type 2 Diabetes Mellitus Vascular Disease
Sponsor: Brigham and Women's Hospital
Start date: 2008-09-01; Completion date: 2014-05-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aldosterone is a significant mediator of cardiovascular injury associated with heart failure and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those of angiotensin converting enzyme inhibitors or angiotensin II (ANGII) receptor blockers. This study will test the hypothesis that mineralocorticoid receptor (MR) antagonists exert beneficial cardiovascular effects, specifically by decreasing vascular injury and improving vascular function. A randomized, double-blind study will be conducted, in which participants with Type 2 Diabetes Mellitus will undergo a series of assessments to test heart, blood vessel, and kidney function at baseline, and after 2 and 6 months of treatment with one of the following drugs:

1. spironolactone
2. hydrochlorothiazide (HCTZ) plus potassium
3. placebo

In the event of insufficient funds, randomization to the placebo arm will be stopped and primary assessment of outcomes will occur at baseline and after 6 months of treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Spironolactone intervention 2: Hydrochlorothiazide + potassium intervention 3: Placebo
Intervention descriptions: intervention 1: 25 mg capsule daily for 6 months intervention 2: hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily intervention 3: Placebo capsule daily

Protocol documents:
Clinical trial NCT00867308
Conditions: Myelodysplastic Syndrome
Keywords: IPSS Int-2 high risk myelodysplastic syndrome MDS) 5q31.1 deletions
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2009-07-01; Completion date: 2014-05-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study of lenalidomide in patients with myelodysplastic syndrome (MDS) and with acute myeloid leukemia (AML) with trilineage dysplasia. Patients will receive two cycles of lenalidomide. Patients who respond may given additional cycles of lenalidomide until disease progression.

Detailed description:
This is a single center open label phase II study of lenalidomide in IPSS Int-1 with increased blasts or hematologic needs with 5q31.1 deletions who have failed to respond to standard dose lenalidomide., IPSS Int-1 with increased blasts or hematologic needs without 5q31.1 deletions, and Int-2 and high risk myelodysplastic syndrome (MDS) patients with or without 5q31.1 deletions, regardless of whether they have received lenalidomide previously or not. Patients will receive two cycles of 15 mg daily lenalidomide (later amended to 50 mg daily lenalidomide) given on days 1-28 out of a 42 day cycle. Within each of the two cycles of lenalidomide, patients will be given up to three weeks with no drug treatment to recover. Patients who fail to respond after two cycles of treatment may receive two additional cycles if stable. Patients who develop clinical response may continue to receive drug until disease progression.

Arms: arm 1: Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study. arm 2: Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression.

Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described.

Patients without evidence of response after 4 cycles will be taken off-study.
Interventions: intervention 1: Lenalidomide 50 mg intervention 2: Lenalidomide 15 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: