ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00477607
Conditions: Ototoxicity Unspecified Adult Solid Tumor
Sponsor: US Department of Veterans Affairs
Start date: 2007-10-01; Completion date: 2011-06-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Alpha-lipoic acid may prevent or lessen hearing loss caused by cisplatin.

PURPOSE: This randomized clinical trial is studying the effectiveness of alpha-lipoic acid in preventing hearing loss in cancer patients undergoing treatment with cisplatin.

Detailed description:
OBJECTIVES:

Primary

Determine the ability of alpha-lipoic acid supplementation to prevent or reduce the incidence and severity of hearing loss in cancer patients undergoing treatment with cisplatin.

Secondary

Determine if this drug improves the oxidative state, as measured by a malondialdehyde measurement of oxidative stress, thereby protecting the patient against ototoxic-induced hearing loss.

OUTLINE: This is a placebo-controlled, double-blind, randomized, multicenter study. Patients are stratified by cancer stage and institution. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral alpha-lipoic acid supplement once a day beginning 1 week before the start of cisplatin treatment and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment.

Arm II: Patients receive oral placebo supplement once a day beginning 1 week before the start of cisplatin and continuing for up to 1 month after the completion of cisplatin. During cisplatin treatment, patients discontinue supplement 1 day prior to the cisplatin treatment and resume daily supplements 2 days post treatment.

Hearing and ototoxicity are assessed at baseline, on each day of chemotherapy, and at 1 and 3 months post chemotherapy.

Blood samples are collected periodically to measure malondialdehyde and alpha-lipoic acid levels.

After completion of treatment with cisplatin, patients are followed for 3 months.

Arms: arm 1: Receiving alpha-lipoic acid during cisplatin treatment. arm 2: Receiving placebo during cisplatin treatment
Interventions: intervention 1: alpha-lipoic acid intervention 2: Audiology intervention 3: laboratory biomarker analysis intervention 4: Placebo
Intervention descriptions: intervention 1: Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment. intervention 2: otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges. intervention 3: Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress. intervention 4: Placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.

Protocol documents:
Clinical trial NCT00504153
Conditions: Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-07-01; Completion date: 2011-06-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying dasatinib to see how well it works in treating patients with previously treated metastatic colorectal cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the progression-free survival of patients with metastatic colorectal cancer who have progressed on or following two prior chemotherapy regimens and are then treated with dasatinib.

SECONDARY OBJECTIVES:

I. Determine the objective response rates in patients treated with dasatinib. II. Determine the overall survival of patients treated with dasatinib. III. Determine the toxicity in patients treated with dasatinib.

TERTIARY OBJECTIVES:

I. Determine the incidence of somatic mutations in c-src, c-yes, fyn, lck, hck, lyn, yrk and csk in archival primary and metastatic colorectal cancer tissues from these patients and to correlate this with clinical outcome.

II. Determine the incidence of total c-src and phosphorylated c-src expression in archival primary and metastatic colorectal cancer specimens from these patients, and to correlate this with clinical outcome.

III. Evaluate the effect of dasatinib on serum VEGF levels.

OUTLINE: This is a multicenter study. Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Blood is collected on days 1 (prior to the first dose of dasatinib) and 15 of course 1 for measurement of VEGF pre-and post-dasatinib administration. Archived tumor tissue (tumor or core biopsy; primary or metastatic lesion) is collected for identification of the incidence of somatic mutations and polymorphisms by polymerase chain reaction and electrophoresis and for measurement of total c-src and phosphorylated src expression by immunohistochemistry.

After completion of study treatment, patients are followed for at least 8 weeks.

Arms: arm 1: Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: dasatinib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00524030
Conditions: Epilepsies, Partial
Keywords: Epilepsy partial seizures pregabalin monotherapy double-blind and randomized trial
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-09-01; Completion date: 2011-06-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

Detailed description:
After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pregabalin 600 mg/day intervention 2: pregabalin 150 mg/day
Intervention descriptions: intervention 1: pregabalin 600 mg/day (300mg BID), duration is 20 weeks. intervention 2: pregabalin 150 mg/day (75mg BID), duration is 20 weeks.

Protocol documents:
Clinical trial NCT00578565
Conditions: Rheumatoid Arthritis Interstitial Pneumonia
Keywords: Rheumatoid Arthritis Interstitial Pneumonia Rheumatology Rituximab
Sponsor: Eric Matteson
Start date: 2007-05-01; Completion date: 2011-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will examine the course of patients with progressive rheumatoid arthritis associated interstitial lung disease (RA-ILD) treated with rituximab for safety and progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be assessed through patient history, physical exams and laboratory parameters.

* Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological subtype) will be enrolled
* The study involves 12 visits over 48 weeks
* Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at six months.

Detailed description:

Arms: arm 1: open label, all subjects will receive rituximab
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months.

Protocol documents:
Clinical trial NCT00581360
Conditions: Adenoid Cystic Carcinoma
Keywords: Adenoid cystic carcinoma bortezomib doxorubicin
Sponsor: University of Pittsburgh
Start date: 2007-11-01; Completion date: 2011-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II trial non-randomized study to evaluate the objective response rate and stable disease rate (primary endpoints), progression-free survival, overall survival and toxicities with the combination of doxorubicin and bortezomib in patients with incurable head and neck adenoid cystic carcinoma. Also, we plan to collect tumor tissue from previous diagnostic procedures and baseline blood specimens for future correlative studies.

Detailed description:
Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles, if there is no progression, bortezomib once a week at a dose of 1.6 mg/m2 on days 1,8,15, every 28 days, will be administered alone. Treatment will continue unless disease progression or intolerable toxicity emerges (see section 5 for detailed treatment plan and dose modifications).

Arms: arm 1: Patients with incurable adenoid cystic carcinoma of the head and neck who receive doxorubicin and bortezomib
Interventions: intervention 1: doxorubicin and bortezomib
Intervention descriptions: intervention 1: Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles, if there is no progression, bortezomib once a week at a dose of 1.6 mg/m2 on days 1,8,15, every 28 days, will be administered alone. Treatment will continue unless disease progression or intolerable toxicity emerges.

Protocol documents:
Clinical trial NCT00596453
Conditions: Prostate Infections
Keywords: Prostate Specific Antigen (PSA) Elevated Prostate Specific Antigen (PSA)
Sponsor: Johns Hopkins University
Start date: 2008-01-01; Completion date: 2011-06-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate infections, including prostate infections. It has been suggested that antibiotic treatment influences PSA levels due to the fact that an increase in PSA levels may be caused by inflammation or swelling of the prostate. Antibiotics are used to treat such inflammatory conditions. However, it has not been proven that antibiotics can be used to lower PSA. This research is being done to see if treatment with the antibiotic Ciprofloxacin hydrochloride affects the Prostate-Specific Antigen (PSA) blood test. This study may also help doctors in deciding which patients need a prostate biopsy.

Detailed description:
This study is directed towards men who have been referred to the Urology clinic at the Johns Hopkins Outpatient Center in Baltimore, MD. If a patient fits the eligibility criteria and signs a consent form, the patient will have his blood drawn for the first PSA measurement. The patient must return to the Johns Hopkins Outpatient Center one week later for a second PSA measurement. The patient will be randomized to receive treatment with placebo or Ciprofloxacin hydrochloride for 14 days. The patient must return to the Johns Hopkins Outpatient Center at the end of the treatment cycle for the third PSA measurement. The patient will return one week later for his biopsy and fourth PSA measurement.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ciprofloxacin hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days intervention 2: Placebo twice a day for 14 days

Protocol documents:
Clinical trial NCT00614484
Conditions: Locally Advanced Non-Small Cell Lung Cancer
Keywords: Proton Radiation
Sponsor: Loma Linda University
Start date: 1999-08-01; Completion date: 2011-06-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.

Detailed description:

Arms: arm 1: Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks.

Proton therapy - 76 Gy in 5 weeks to lung tumor.
Interventions: intervention 1: Proton Radiation Therapy intervention 2: Taxol intervention 3: Carboplatin
Intervention descriptions: intervention 1: A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy. intervention 2: 200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy. intervention 3: AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.

Protocol documents:
Clinical trial NCT00641641
Conditions: HIV Infection
Keywords: Viral compartments integrase inhibitor therapy viral species
Sponsor: Kirby Institute
Start date: 2008-03-01; Completion date: 2011-06-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure the decay characteristics of HIV in the blood of patients after taking a combination of anti-HIV drugs, which includes a new class of anti-HIV drug, an integrase inhibitor. This study explores how this new combination of therapy reduces virus in various compartments of the body and immune system.

Detailed description:
The study is an open-label study of 3-years duration. This study will be conducted at 4 study sites in Sydney, Australia. Sixteen participants will be recruited comprising 8 participants diagnosed with primary HIV infection (Cohort A) and 8 individuals with chronic HIV infection (Cohort B). All patients must be antiretroviral therapy (ART) naïve and will commence a regimen of combination ART consisting of tenofovir disoproxil fumarate and emtricitabine (TDF/FTC; Truvada) plus the integrase inhibitor, raltegravir. Subjects will be followed for three years with intensive quantification of both plasma RNA and cell associated DNA viral species.

Arms: arm 1: tenofovir (TDF) + emtricitabine (FTC) as a fixed dose combination administered orally once per day and raltegravir (RAL) administered orally twice per day.
Interventions: intervention 1: Tenofovir + emtricitabine + raltegravir.
Intervention descriptions: intervention 1: TDF 300mg once daily + FTC 200mg once daily + RAL 400mg twice daily.

Protocol documents:
Clinical trial NCT00659789
Conditions: HIV I Infection
Sponsor: Bionor Immuno AS
Start date: 2008-08-01; Completion date: 2011-06-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Detailed description:
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.

ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.

Arms: arm 1: Vacc-4x reconstituted in sterile water (0.1 mL) at a dose of 1.2mg per intradermal administration. Participants are given a total of 6 immunizations over 18 weeks (weeks 1, 2, 3, 4, 16, 18). Recombinant human granulocyte macrophage colony stimulating factor (rhuGM-CSF) Leukine (0.06mg in 0.1 mL) administered intradermally is used as a local adjuvant. arm 2: Placebo injections consisting of sterile water (0.1 mL) in place of Vacc-4x. Placebo injections consisting of sterile water (0.1 mL) in place of Leukine.
Interventions: intervention 1: Vacc-4x intervention 2: Sterile water
Intervention descriptions: intervention 1: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. intervention 2: Sterile water is used in place of Vacc-4x and in place of Leukine

Protocol documents:
Clinical trial NCT00661492
Conditions: Androgen-independent Prostate Cancer
Keywords: Androgen-independent prostate cancer(AIPC)
Sponsor: US Oncology Research
Start date: 2008-05-01; Completion date: 2011-06-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the time to progression produced by the combination of Novantrone (mitoxantrone) and Erbitux (cetuximab) versus Novantrone alone in metastatic AIPC patients previously treated with docetaxel-based chemotherapy. TTP is defined as time from the start of treatment date to the date the patient is first recorded as having disease progression, even in patients who discontinue study treatment early due to toxicity.

Detailed description:
This is a nonblinded, randomized phase II study to determine the activity of Novantrone (mitoxantrone) with or without Erbitux (cetuximab) in patients with androgen independent prostate cancer (AIPC) who have been treated previously with docetaxel chemotherapy. The Novantrone (mitoxantrone)-only treatment arm will serve as a concurrent control arm to aid in the determination of the benefit of the Novantrone (mitoxantrone)-Erbitux (cetuximab) combination in this setting.

Patients will be randomly assigned 2:1 to 1 of 2 treatment arms; 93 patients in Arm 1 and 47 patients in Arm 2. A balanced randomization procedure will be performed utilizing a code list that will be developed prior to the study opening. Because the patients will be stratified by performance status (ECOG 0 and 1 vs. ECOG 2), the list will be developed to ensure a balance between the 2 treatment arms.

Arms: arm 1: Erbitux (cetuximab) and Novantrone (mitoxantrone) arm 2: Novantrone (mitoxantrone)
Interventions: intervention 1: cetuximab intervention 2: Mitoxantrone
Intervention descriptions: intervention 1: Erbitux (cetuximab) IV over 2 hours (loading dose) on Day 1 (Cycle 1 only), followed by Erbitux (cetuximab) IV over 1 hour weekly thereafter intervention 2: Novantrone (mitoxantrone) IV Day 1 + Prednisone QD for ten (10) 21-day cycles Standard androgen deprivation therapy (ADT) will be continued in all patients who enter study on LHRH agonists

Protocol documents:
Clinical trial NCT00663260
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Start date: 2008-06-01; Completion date: 2011-06-01
Enrollment: 631 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Detailed description:
All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 10 mg, Once Daily, 104 weeks intervention 2: Tablets, Oral, 5 mg, Once Daily, 104 weeks intervention 3: Tablets, Oral, 0 mg, Once Daily, 104 weeks

Protocol documents:
Clinical trial NCT00678015
Conditions: Prostate Cancer
Keywords: NDGA Prostate Cancer
Sponsor: University of California, San Francisco
Start date: 2008-05-01; Completion date: 2011-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, single center study measuring the pharmacokinetic parameters of NDGA administration and assessing the proportion of patients who experience a 50% decline in PSA.

Detailed description:
This study is a phase II trial of NDGA in patients with hormone-sensitive non-metastatic prostate cancer with a pharmacokinetics component. The first six patients enrolled will be treated with a single 750 mg dose of oral NDGA on day -7 with measurement of pharmacokinetic parameters over eight hours after the dose, then begin treatment with 2000 mg of oral NDGA daily. Every four weeks, measurement of pharmacokinetic parameters at steady state will be done for all patients. All patients will continue dosing with NDGA and will be followed for PSA response and for safety. Measurement of pharmacokinetics for a 750 mg dose has been chosen to evaluate levels with the dosage that patients will be taking at one time point during the day (this is roughly one-third of the daily dose, which is administered in three divided doses).

Arms: arm 1: None
Interventions: intervention 1: Nordihydroguaiaretic Acid (NDGA)
Intervention descriptions: intervention 1: NDGA 2000mg daily

Protocol documents: