ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00255125
Conditions: Prostate Neoplasm
Keywords: Estrogen Receptor Isoflavones Prostate Neoplasm Soy Supplementation
Sponsor: VA Office of Research and Development
Start date: 2005-09-01; Completion date: 2009-10-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.

Detailed description:
This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patients will be randomized to either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. The specific objectives are:

1. To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens.
2. To assess the impact of soy supplementation on estrogen receptor expression(ER).
3. To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.

Arms: arm 1: Placebo arm 2: Soy Supplement
Interventions: intervention 1: Soy Supplement intervention 2: Placebo
Intervention descriptions: intervention 1: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice). intervention 2: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).

Protocol documents:
Clinical trial NCT00262301
Conditions: Hereditary Angioedema Angioneurotic Edema Genetic Disorders
Sponsor: Pharming Technologies B.V.
Start date: 2004-06-01; Completion date: 2009-10-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that leads to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.

Detailed description:
A prospectively planned interim analysis will be performed on the double-blind data.

Arms: arm 1: 100 IU/kg recombinant human C1 inhibitor arm 2: Saline solution
Interventions: intervention 1: recombinant human C1 inhibitor intervention 2: Placebo
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol documents:
Clinical trial NCT00266279
Conditions: Head or Neck Cancer
Sponsor: University of Louisville
Start date: 2005-04-01; Completion date: 2009-10-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II study will test the response rate of combined oxaliplatin and capecitabine treatment when administered at a given dose and schedule, in patients with Head and Neck cancer for which there is no curative treatment.

Detailed description:
The optimal dose and schedule for the combined treatment with oxaliplatin and capecitabine have not been defined. The aim of this Phase II study is to determine the response rate of combined oxaliplatin and capecitabine treatment at a given dose and schedule in patients with Head and Neck cancer for which there is no curative treatment.

The study also aims to determine the qualitative and quantitative toxicity and reversibility of toxicity of the above combination and to evaluate any changes in performance status, quality of life, overall survival and progression-free survival.

Arms: arm 1: Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.
Interventions: intervention 1: Oxaliplatin, Capecitabine
Intervention descriptions: intervention 1: Agent, DOSE AND SCHEDULE (28-days cycle):

Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21

Protocol documents:
Clinical trial NCT00376168
Conditions: Gaucher Disease
Sponsor: Pfizer
Start date: 2007-08-01; Completion date: 2009-10-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.

Detailed description:
This will be a multi-center, randomized, double-blind, parallel group, dose-ranging trial to assess the safety and efficacy of prGCD in 30 untreated patients with Gaucher disease. Patients will receive IV infusion of prGCD every two weeks at the selected medical center. The duration of the study will be nine months. At the end of the 9-month treatment period (20 visits, 38 weeks) eligible patients will be offered enrollment in an open-label extension study.

There will be two treatment groups, 15 patients in each treatment group.

Treatment Group I: 30 units/kg every 2 weeks. Treatment Group II: 60 units/kg every 2 weeks.

All patients will have pharmacokinetic data collected over approximately 3 hours with frequent blood samples following the first and final doses of prGCD.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Plant cell expressed recombinant glucocerebrosidase (prGCD) intervention 2: Plant cell expressed recombinant glucocerebrosidase (prGCD)
Intervention descriptions: intervention 1: Intravenous infusion every two weeks for 9 months intervention 2: Intravenous infusion every 2 weeks for 9 months

Protocol documents:
Clinical trial NCT00384865
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Arterial Hypertension
Sponsor: University of Pennsylvania
Start date: 2006-09-01; Completion date: 2009-10-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine whether aspirin and simvastatin are safe and effective for the treatment of pulmonary arterial hypertension (PAH).

Detailed description:
PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. In PAH, in situ thrombosis may occur in the lungs, and pulmonary endothelial dysfunction is well-recognized. As aspirin inhibits platelet aggregation, there may be value in using aspirin to treat PAH. Simvastatin has beneficial effects on blood vessels in other types of cardiovascular disease. Therefore, simvastatin may similarly benefit patients with PAH.

Participants in this study will be randomly assigned to receive 6 months of daily placebo tablets, daily aspirin and daily placebo, daily simvastatin and daily placebo, or daily aspirin and daily simvastatin in a double-blind fashion. The study will compare the safety and efficacy of aspirin to placebo and simvastatin to placebo.

Arms: arm 1: Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months

Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months arm 2: Aspirin: Aspirin 81 mg, taken orally, once a day for 6 months

Placebo taken orally, once a day for 6 months arm 3: Placebo taken orally, once a day for 6 months

Simvastatin: Simvastatin 40 mg, taken orally, once a day for 6 months arm 4: Placebo taken orally, once a day for 6 months

Placebo taken orally, once a day for 6 months
Interventions: intervention 1: Simvastatin intervention 2: Aspirin intervention 3: Placebo
Intervention descriptions: intervention 1: Simvastatin 40 mg, taken orally, once a day for 6 months intervention 2: Aspirin 81 mg, taken orally, once a day for 6 months intervention 3: Placebo, taken orally, once a day for 6 months

Protocol documents:
Clinical trial NCT00404092
Conditions: Invasive Aspergillosis
Keywords: aspergillosis caspofungin maximum tolerated dose
Sponsor: University of Cologne
Start date: 2006-10-01; Completion date: 2009-10-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the safety and tolerability as well as the efficacy and pharmacokinetics of caspofungin in four escalating dosages in adult patients with hematologic malignancies and proven or probable invasive aspergillosis.

Detailed description:
Due to its efficacy and a broad antifungal spectrum against relevant fungal pathogens, lack of cross-resistance to azoles and amphotericin B, documented efficacy against human Aspergillus infections, favorable pharmacokinetic properties, and excellent tolerability according to the current data, caspofungin is a highly promising candidate for improving the results of treatment of invasive fungal infections.

Preclinical and clinical data indicate a dose dependent antifungal efficacy of caspofungin as well as of other echinocandins such as micafungin and anidulafungin. Thus it appears reasonable to investigate the impact of higher doses of caspofungin to improve the results already achieved with this component so far.

The maximum tolerated dose (MTD) of caspofungin and the distribution of the drug in patients following administration of doses of 70 mg or more are not yet known. We therefore investigate the safety, tolerability and pharmacokinetics of caspofungin in rising doses in a dose escalation study in adult patients with proven or probable invasive aspergillosis.

Arms: arm 1: 70mg caspofungin 1x/day arm 2: 100mg caspofungin 1x/day arm 3: 150mg caspofungin 1x/day arm 4: 200mg caspofungin 1x/day
Interventions: intervention 1: caspofungin
Intervention descriptions: intervention 1: i.v.

Protocol documents:
Clinical trial NCT00412542
Conditions: Glioblastoma Multiforme Glioma
Keywords: Glioblastoma Multiforme Glioma Thalidomide Thalomid CPT-11 Irinotecan malignant glioma
Sponsor: M.D. Anderson Cancer Center
Start date: 2003-10-01; Completion date: 2009-10-01
Enrollment: 78 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives:

1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.

1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11.

1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.

1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.

Detailed description:
Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing.

All participants will take thalidomide capsules by mouth every evening at bedtime. You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week. After that, you will increase the dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you experience any severe side effects.

In addition to thalidomide, you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug. This 6 week period is called a course of therapy. The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years.

THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is investigational.

Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
Interventions: intervention 1: Thalidomide intervention 2: CPT-11 intervention 3: MRI Scan intervention 4: Quantitative Sensory Tests (QST)
Intervention descriptions: intervention 1: 100 mg PO (by mouth) daily for 8 weeks intervention 2: 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest intervention 3: Dynamic MRI scan with dye injection through vein, every 6 weeks intervention 4: QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.

Protocol documents:
Clinical trial NCT00423800
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-01; Completion date: 2009-10-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of \>600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy. Participants will be required to have their baseline and Week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor. No additional interventions outside of the clinic's standard of care and the conditions of the Canadian product monograph for Pegetron® will be applied to participants.

Detailed description:

Arms: arm 1: Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 16 weeks of treatment arm 2: Participants are treated with Pegetron® (pegylated interferon alfa-2b and ribavirin) for 8 weeks and then randomized to an additional 40 weeks of treatment.
Interventions: intervention 1: Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
Intervention descriptions: intervention 1: 1. Powder for Solution in Redipen® (pegylated interferon alfa-2b) (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks
2. 200 mg ribavirin capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks

Protocol documents:
Clinical trial NCT00424346
Conditions: Rheumatoid Arthritis
Keywords: Active Rheumatoid Arthritis anti-interleukin-1beta monoclonal antibody methotrexate
Sponsor: Novartis
Start date: 2006-11-01; Completion date: 2009-10-01
Enrollment: 274 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The 12-week core study was designed to evaluate risk-benefit of three subcutaneous dose regimens of ACZ885, added on to stable methotrexate (MTX) therapy (greater than or equal to 7.5 mg/week), compared to placebo in patients with active rheumatoid arthritis (RA). The study investigated the magnitude of effect as well as onset of effect for the different dose regimens.

The primary objective of the extension studies was to assess long-term safety and tolerability of canakinumab (ACZ885) in patients with active RA. CACZ885A2201E1 evaluated this objective in patients who had participated in the core study (CACZ885A2201) and CACZ885A2201E2 did the same in patients who completed the first extension study.

Detailed description:

Arms: arm 1: Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks. arm 2: Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. arm 3: Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. arm 4: Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Interventions: intervention 1: Canakinumab intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00424502
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2007-01-01; Completion date: 2009-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate
Intervention descriptions: intervention 1: 1g iv on days 1 and 15 intervention 2: 10-25mg po/week

Protocol documents:
Clinical trial NCT00431496
Conditions: Anemia Secondary Hyperparathyroidism
Keywords: Anemia Intact Parathyroid Hormone (iPTH) Secondary Hyperparathyroidism (SHPT)
Sponsor: Amgen
Start date: 2006-09-01; Completion date: 2009-10-01
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product.

Detailed description:

Arms: arm 1: Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was \> 31.8 pmol/L (300 pg/mL) unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was \< 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase.
Interventions: intervention 1: Cinacalcet
Intervention descriptions: intervention 1: Cinacalcet tablets

Protocol documents:
Clinical trial NCT00454181
Conditions: Papillomatosis HIV Infections
Keywords: human immunodeficiency virus human papilloma virus warts, oral papillomatosis treatment experienced
Sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Start date: 2007-02-01; Completion date: 2009-10-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in HIV-positive adults.

The hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete remission of their oral warts compared to subjects given placebo.

Detailed description:
Human papilloma virus (HPV) can cause warts to form in the mouth of infected patients, particularly those with reduced immunity such as people infected with HIV. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges, can reduce or eliminate these warts in HIV+ subjects who are receiving combination anti-retroviral therapy (HAART). All potential subjects will have their warts examined and measured at a screening visit. A small amount of one wart (i.e. a biopsy) will be removed for microscopic evaluation to confirm HPV infection and a small amount of blood will be collected for testing. Subjects that qualify for entry will return for a baseline visit at which they will be randomized to active or placebo treatment for 24 weeks. Three out of four subjects will receive active treatment in this study. Subjects must return to the clinic every 6 weeks during treatment to have their warts re-examined. At these follow-up visits, subjects will be asked to complete a brief questionnaire regarding any perceived changes in their warts and their overall mouth condition. A small amount of blood will be taken at the final study visit at week 24 to assess the safety of the interferon lozenges.

Arms: arm 1: 500 IU Interferon-alpha lozenges for oral dissolution arm 2: 200 mg lozenges containing anhydrous crystalline maltose
Interventions: intervention 1: Interferon-alpha intervention 2: placebo
Intervention descriptions: intervention 1: 500 IU interferon-alpha lozenges taken 3 times per day for 24 weeks intervention 2: 200 mg lozenges containing anhydrous crystalline maltose taken three times per day for 24 weeks

Protocol documents: