ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01490788
Conditions: Healthy
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2011-11-18; Completion date: 2011-12-30
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Detailed description:
Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed conditions.

Arms: arm 1: 1 x TNX-102 2.4 mg gelcap under fasting conditions arm 2: 1 x cyclobenzaprine 5 mg immediate release (IR) tablet under fasting conditions arm 3: 1 x TNX-102 2.4 mg gelcap under fed conditions
Interventions: intervention 1: Treatment A intervention 2: Treatment B intervention 3: Treatment C
Intervention descriptions: intervention 1: TNX-102 2.4 mg - 1 gelcap once under fasting conditions. intervention 2: Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions intervention 3: TNX-102 2.4 mg, 1 gelcap once given under fed conditions.

Protocol documents:
Clinical trial NCT00232180
Conditions: Heart Failure
Keywords: Open-label single arm mortality/morbidity trial eplerenone chronic systolic heart failure
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-03-01; Completion date: 2012-01-01
Enrollment: 2743 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone

Detailed description:

Arms: arm 1: Eplerenone administered on top of background standard heart failure therapy
Interventions: intervention 1: Eplerenone
Intervention descriptions: intervention 1: Eplerenone administered on top of background standard heart failure therapy

Protocol documents:
Clinical trial NCT00565448
Conditions: Nasopharyngeal Neoplasms Carcinoma
Keywords: Nasopharyngeal carcinoma
Sponsor: Sanofi
Start date: 2007-11-01; Completion date: 2012-01-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to estimate the Complete Response rate of docetaxel to the combination of cisplatin-5-fluorouracil (TCF) compared to cisplatin-5-fluorouracil (CF) in the Induction treatment of Nasopharyngeal Carcinoma (NPC).

The secondary objectives are to determine:

* the safety of TCF in comparison to CF after induction treatment of NPC,
* the pharmacokinetics of docetaxel when added to CF,
* the Overall Response rate of TCF and CF on completion of induction and consolidation (chemo-radiotherapy) treatment of NPC, and to compare overall survival between TCF and CF.

Detailed description:
Planned treatment duration:

* induction period: 9 weeks of induction treatment
* consolidation period: 9 weeks of chemoradiation treatment.

The consolidation treatment was the same for all participants: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.

Arms: arm 1: * Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks
* Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks
* 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy

Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. arm 2: * Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks
* 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy.

Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks.
Interventions: intervention 1: docetaxel intervention 2: cisplatin intervention 3: 5-fluorouracil
Intervention descriptions: intervention 1: Pharmaceutical form:solution for infusion

Route of administration:intravenous intervention 2: Pharmaceutical form:solution for infusion

Route of administration:intravenous intervention 3: Pharmaceutical form:solution for infusion

Route of administration:intravenous

Protocol documents:
Clinical trial NCT00615264
Conditions: Type 1 Diabetes
Sponsor: Andromeda Biotech Ltd.
Start date: 2005-09-01; Completion date: 2012-01-01
Enrollment: 457 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if DiaPep277 can effectively protect the internal production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the immune system and is expected to prevent further destruction of the beta-cells by stimulating regulatory responses, without causing immunological suppression.

Detailed description:

Arms: arm 1: DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion. arm 2: Mannitol 40 mg in 0.5 mL lipid emulsion.
Interventions: intervention 1: DiaPep277 intervention 2: Placebo
Intervention descriptions: intervention 1: 1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months intervention 2: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Protocol documents:
Clinical trial NCT00819052
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2008-12-01; Completion date: 2012-01-01
Enrollment: 445 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.

Detailed description:

Arms: arm 1: 200 mg orally twice a day (po BID) arm 2: 400 mg orally once a day (po QD)
Interventions: intervention 1: Nevirapine XR intervention 2: Nevirapine XR intervention 3: Nevirapine IR
Intervention descriptions: intervention 1: Nevirapine XR intervention 2: Nevirapine extended release intervention 3: Nevirapine Immediate Release

Protocol documents:
Clinical trial NCT01115569
Conditions: Chronic Pain
Keywords: chronic pain
Sponsor: Zogenix, Inc.
Start date: 2010-05-01; Completion date: 2012-01-01
Enrollment: 424 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

Detailed description:
Subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

Arms: arm 1: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.
Interventions: intervention 1: Hydrocodone Bitartrate
Intervention descriptions: intervention 1: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks

Protocol documents:
Clinical trial NCT01119859
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-05-01; Completion date: 2012-01-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

Detailed description:

Arms: arm 1: Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. arm 2: Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
Interventions: intervention 1: Tocilizumab intervention 2: Adalimumab intervention 3: Placebo to tocilizumab intervention 4: Placebo to adalimumab
Intervention descriptions: intervention 1: The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period. intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01130532
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction ED Impotence
Sponsor: Eli Lilly and Company
Start date: 2010-08-01; Completion date: 2012-01-01
Enrollment: 623 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow men to return to normal erectile function in those who did not have normal erectile function following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.

Detailed description:

Arms: arm 1: 2.5 mg for 4 weeks, followed by 5 mg for 8 weeks with option to continue treatment at 5 mg for an additional 4 weeks arm 2: 5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks arm 3: for 12 weeks
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: Administer orally intervention 2: Administer orally

Protocol documents:
Clinical trial NCT01207414
Conditions: Schizophrenia
Keywords: Schizophrenia iloperidone switch gradual switch immediate switch
Sponsor: Novartis
Start date: 2010-08-01; Completion date: 2012-01-01
Enrollment: 501 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult subjects with schizophrenia who require a change in their current antipsychotic treatment of risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or safety/tolerability reasons.

Detailed description:

Arms: arm 1: Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks. arm 2: Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.

On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.
Interventions: intervention 1: iloperidone
Intervention descriptions: intervention 1: Iloperidone tablets supplied at doses of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to achieve a target dose of 12-24 mg/day for 12 weeks.

Protocol documents:
Clinical trial NCT00003476
Conditions: Childhood Brain Tumor
Keywords: childhood anaplastic astrocytoma recurrent childhood anaplastic astrocytoma childhood glioblastoma multiforme recurrent childhood glioblastoma multiforme childhood brainstem glioma recurrent childhood brainstem glioma childhood primitive neuroectodermal tumor recurrent childhood primitive neuroectodermal tumor
Sponsor: Burzynski Research Institute
Start date: 1996-03-01; Completion date: 2012-01-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for children with primary malignant brain tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with primary malignant brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with primary malignant brain tumors.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in children with primary malignant brain tumors 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 children with primary malignant brain tumors.

OVERVIEW: This is a single arm, open-label study in which children with primary malignant brain tumors 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: Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00041067
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer
Sponsor: SWOG Cancer Research Network
Start date: 2002-09-01; Completion date: 2012-01-01
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.

Detailed description:
OBJECTIVES:

* Determine the 1-year survival of women with HER2-positive stage IV breast cancer treated with trastuzumab (Herceptin), docetaxel, and vinorelbine with filgrastim (G-CSF) support.
* Determine the response rate (complete and partial, confirmed and unconfirmed) in the subset of patients with measurable disease treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Obtain tissue blocks for the determination of predictors of response (e.g., beta-tubulin mutations) to microtubule interacting agents in this patient population and for other future studies.

OUTLINE: This is a pilot, multicenter study.

Patients receive docetaxel IV over 1 hour on day 1, filgrastim (G-CSF) subcutaneously on days 2-21, vinorelbine IV over 6-10 minutes on days 8 and 15, and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. If docetaxel and vinorelbine are discontinued due to unacceptable toxicity, patients may continue to receive trastuzumab. If trastuzumab is discontinued due to unacceptable toxicity, patients may continue to receive chemotherapy with G-CSF support.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18-22.5 months.

Arms: arm 1: Trastuzumab, docetaxel, vinorelbine and filgrastim
Interventions: intervention 1: filgrastim intervention 2: trastuzumab intervention 3: docetaxel intervention 4: vinorelbine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00073957
Conditions: Lymphoma
Keywords: recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma anaplastic large cell lymphoma
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2003-12-01; Completion date: 2012-01-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.

Detailed description:
OBJECTIVES:

* Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab.
* Determine the event-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

* Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.
* CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29.
* Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Arms: arm 1: Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine
Interventions: intervention 1: rituximab intervention 2: cytarabine intervention 3: liposomal cytarabine intervention 4: yttrium Y 90 ibritumomab tiuxetan
Intervention descriptions: intervention 1: None intervention 2: to be used for CNS prophylaxis intervention 3: to be used as CNS prophylaxis intervention 4: None

Protocol documents:
Clinical trial NCT00106353
Conditions: Adenocarcinoma Neoplasms
Keywords: Pediatric Tumors
Sponsor: Pfizer
Start date: 2005-03-01; Completion date: 2012-01-01
Enrollment: 71 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors.

Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Torisel
Intervention descriptions: intervention 1: 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity.

Protocol documents: