ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00902174
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension Imatinib 6MWD Borg scale Pulmonary hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2009-09-01; Completion date: 2011-05-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (PAH).

Detailed description:

Arms: arm 1: Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted. arm 2: Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
Interventions: intervention 1: imatinib mesylate intervention 2: Placebo
Intervention descriptions: intervention 1: Two or 4 imatinib mesylate (QTI571) 100 mg film coated tablets once daily. intervention 2: Placebo to imatinib 100 mg film coated tablets

Protocol documents:
Clinical trial NCT00908908
Conditions: Advanced Solid Tumors
Keywords: Advanced Solid Tumors Failure of Multiple Prior Chemotherapy Regimens
Sponsor: Eisai Inc.
Start date: 2009-03-01; Completion date: 2011-05-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled eribulin acetate (14C-eribulin) in patients with advanced solid tumors.

Detailed description:
The study will be conducted in two phases, the initial Study phase to administer the radio-labeled 14C-eribulin and collection of PK samples, and the Extension Phase when the patients will continue to receive non-radio-labeled eribulin. In the initial Study phase, patients will receive a single 2 mg flat dose of 14C-eribulin (approximately 80 to 90 microCuries) administered on Cycle 1 Day 1 as an intravenous (IV) bolus injection or infusion over 2-5 minutes. Following this initial dose, patients will remain in the research unit until Day 8 to complete sample collections of urine, blood and feces for PK analysis and determination of 14C-eribulin concentrations between Days 1 and 8.

On Day 8 patients will be re-assessed and discharged, and return on day 15 for physical exam, adverse event evaluation, and lab tests. The patients will then enter the Extension Phase of the study and continue to receive on-radio-labeled eribulin at a dose of 1.4 mg/m\^2 on Days 1 and 8 of every 21 day cycle.

Arms: arm 1: None
Interventions: intervention 1: eribulin
Intervention descriptions: intervention 1: Cycle 1 day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m\^2 of non-radio-labeled eribulin thereafter on days 1 and 8 every 21 days.

Protocol documents:
Clinical trial NCT01079234
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2010-03-01; Completion date: 2011-05-01
Enrollment: 493 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine intervention 3: insulin aspart
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily intervention 2: Insulin glargine injected subcutaneously (under the skin) once daily intervention 3: At least three daily doses at meal-time

Protocol documents:
Clinical trial NCT00003475
Conditions: Malignant Brain Tumors
Keywords: adult glioblastoma multiforme adult anaplastic astrocytoma adult anaplastic astrocytoma/Mixed
Sponsor: Burzynski Research Institute
Start date: 1996-02-01; Completion date: 2011-05-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for adults with primary malignant brain tumors that have not responded to standard therapy provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with primary malignant brain tumors that have not responded to standard therapy.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with primary malignant brain tumors that have not responded to standard therapy.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with primary malignant brain tumors that have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with a primary malignant brain tumor.

OVERVIEW: This is a single arm, open-label study in which adults with malignant brain tumors that have not responded to standard therapy receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Protocol documents:
Clinical trial NCT00070291
Conditions: Lymphoma
Keywords: angioimmunoblastic T-cell lymphoma
Sponsor: Eastern Cooperative Oncology Group
Start date: 2006-01-24; Completion date: 2011-05-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.

PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.

Secondary

* Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.

Arms: arm 1: High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
Interventions: intervention 1: cyclosporine
Intervention descriptions: intervention 1: Cyclosporine doses will be based on actual body weight unless actual body weight is \> 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity

Protocol documents:
Clinical trial NCT00111813
Conditions: Multiple Myeloma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-09-01; Completion date: 2011-05-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are:

* To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
* To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Detailed description:

Arms: arm 1: Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle. arm 2: Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle. arm 3: Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle. arm 4: Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle. arm 5: Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle. arm 6: Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
Interventions: intervention 1: vorinostat intervention 2: bortezomib
Intervention descriptions: intervention 1: Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break). intervention 2: Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.

Protocol documents:
Clinical trial NCT00303966
Conditions: Refractory Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2005-11-01; Completion date: 2011-05-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. This phase II trial is studying how well sorafenib works in treating patients with relapsed chronic lymphocytic leukemia.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with recurrent chronic lymphocytic leukemia (CLL) treated with sorafenib.

II. Determine the toxicity in patients treated with sorafenib.

SECONDARY OBJECTIVES:

I. Correlate bone marrow angiogenesis, CLL tumor cell expression of vascular endothelial growth factor (VEGF), VEGF receptors (flt-1, KDR, flt-4 and neuropilin-1), basic fibroblast growth factor, and plasma interleukin-8 levels with response.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Arms: arm 1: Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sorafenib tosylate
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00345332
Conditions: Urinary Incontinence
Sponsor: University of Rochester
Start date: 2005-10-01; Completion date: 2011-05-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

Detailed description:
A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.

Arms: arm 1: Placebo arm 2: Botox
Interventions: intervention 1: Botox intervention 2: Placebo
Intervention descriptions: intervention 1: Injected intervention 2: Injected

Protocol documents:
Clinical trial NCT00419380
Conditions: Otitis Media
Keywords: clogged ear tubes
Sponsor: University of Colorado, Denver
Start date: 2007-01-01; Completion date: 2011-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the new drug for any problems related to the medication. Patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes. This problem occasionally is improved with ear drops like Floxin®. However, it is frequently not improved even after this standard ear drop treatment.

Detailed description:
The success in treating blocked tubes may relate to the ability to dissolve the material clogging the tube as well as dealing with the thick fluid in the middle-ear. The reasoning behind this study is that the use of Pulmozyme® may be able to treat both of these problems. Pulmozyme® was approved by the FDA in 1994 for the treatment of cystic fibrosis patients. Infections present in airway (lung) secretions of cystic fibrosis patients and the material that plugs ear tubes are in some ways the same. "Off-label" use of a drug is the practice by physicians to use a FDA-approved drug in treating conditions other than what the original approval was intended for. Pulmozyme® has been used to treat other lung diseases not related to cystic fibrosis. There has been no published report on the use of Pulmozyme® to treat ear infections. This study is a clinical trial that compares two treatments and will last for 3 months.

Arms: arm 1: dornase alfa - Pulmozyme®: 5 drops twice daily for 7 days to the affected ear. arm 2: Ofloxin : 5 drops twice daily for 7 days to the affected ear.
Interventions: intervention 1: dornase alfa (Pulmozyme®)
Intervention descriptions: intervention 1: This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment \[dornase alfa (Pulmozyme®)\]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.

Protocol documents:
Clinical trial NCT00428441
Conditions: Venous Thromboembolism
Keywords: D-dimer Recurrence Venous thromboembolism
Sponsor: Università degli Studi dell'Insubria
Start date: 2007-05-01; Completion date: 2011-05-01
Enrollment: 73 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Optimal duration of oral anticoagulant therapy in patients with recurrent episodes of venous thromboembolism (VTE) is a matter of debate and recommendations are based on inadequate evidence. More than 12 months of treatment are currently recommended, and the grade of recommendation is low.

The PROLONG study has recently evaluated the predictive role of D-dimer measurement after withholding oral anticoagulant treatment in patients with a first episode of VTE. Patients with a positive D-dimer had a significantly higher incidence of VTE recurrences than patients with a negative D-dimer and required resumption of the antithrombotic treatment. Based on the results of this and of previous cohort studies, it appears safe to withhold treatment in patients with negative D-dimer values and to continue treatment in patients with altered D-dimer levels.

Aim of this study is therefore to assess the negative predictive value of D-dimer also in patients with recurrent VTE and to evaluate the clinical utility of this approach in this patient setting.

Detailed description:

Interventions: intervention 1: Warfarin
Intervention descriptions: intervention 1: tablets, based on INR levels, according to D-dimer levels

Protocol documents:
Clinical trial NCT00460421
Conditions: Leukemia
Keywords: Oral Mucositis Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Palifermin Kepivance
Sponsor: Swedish Orphan Biovitrum
Start date: 2006-08-01; Completion date: 2011-05-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body irradiation \[TBI\]) followed by hematopoietic stem cell transplant (HSCT). The study will evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses (40 μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are to be evaluated in each age group (1 to 2, 3 to 11, and 12 to 16 years, respectively) using a conventional dose escalation design. Palifermin is administered for 3 consecutive days (Day -10 to Day -8, respectively) before the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well tolerated, efficacious dose in each age group. Patients will also be followed for secondary malignancies, progression-free survival (PFS) and overall survival (OS)

Detailed description:

Arms: arm 1: A 3 dose escalation design. Sucessive cohorts of patient (9 patients per group) will each be administered Palifermin as an IV bolus injection (40, 60 or 80 µg) once daily for 3 consecutive days before the start of conditioning regimen (chemotherapy and total body irradiation) and after HCST (Day -10, -9, -8 and Day 0, +1, +2 respectively).
Interventions: intervention 1: Palifermin intervention 2: Total Body irradiation intervention 3: Chemotherapy
Intervention descriptions: intervention 1: Palifermin will be administered as an IV bolus injection (40, 60 or 80 µg/kg/day)once daily for 3 consecutive days before the start of conditioning regimen and after HCST (Day -10, -9, -8 and Day 0, +1, +2 respectively). intervention 2: None intervention 3: High dose etoposide, Cyclophosphamide

Protocol documents:
Clinical trial NCT00507689
Conditions: Chronic Hepatitis B
Keywords: Truvada HBIg Chronic Hepatitis B Recurrence Post Orthotopic Liver Transplant
Sponsor: Gilead Sciences
Start date: 2007-09-01; Completion date: 2011-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis B following liver transplantation, in participants who were chronically infected with hepatitis B prior to transplantation.

Prior to enrollment, participants were required to have received at least 12 weeks of HBIg therapy following liver transplantation. Enrolled participants then received FTC/TDF plus HBIg for an initial 24-week pre-randomization treatment period. Participants who completed the pre-randomization period and who achieved sustained viral suppression were randomized to continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse events and various laboratory parameters.

Detailed description:

Arms: arm 1: Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. arm 2: Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period.
Interventions: intervention 1: FTC/TDF intervention 2: Hepatitis B Immunoglobulin (HBIg)
Intervention descriptions: intervention 1: Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg was administered as a fixed-dose combination tablet orally once daily. intervention 2: HBIg was administered either intravenously or by intramuscular injection at a dose and frequency as prescribed by the investigative site protocol.

Protocol documents:
Clinical trial NCT00509665
Conditions: Head and Neck Cancer
Keywords: recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent adenoid cystic carcinoma of the oral cavity recurrent basal cell carcinoma of the lip recurrent mucoepidermoid carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity recurrent metastatic squamous neck cancer with occult primary recurrent lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity recurrent inverted papilloma of the paranasal sinus and nasal cavity recurrent midline lethal granuloma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer recurrent lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the oropharynx
Sponsor: Medical University of South Carolina
Start date: 2005-06-01; Completion date: 2011-05-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with doxorubicin works in treating patients with recurrent or progressive head and neck cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: doxorubicin hydrochloride intervention 2: gemcitabine hydrochloride
Intervention descriptions: intervention 1: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. intervention 2: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle

Protocol documents: