ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00144170
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2003-02-01; Completion date: 2008-10-01
Enrollment: 882 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tipranavir (with low dose ritonavir) intervention 2: Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00199381
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease levodopa end of dose wearing off OFF time
Sponsor: Kyowa Kirin, Inc.
Start date: 2005-10-01; Completion date: 2008-10-01
Enrollment: 504 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Detailed description:
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Arms: arm 1: Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
Interventions: intervention 1: Istradefylline
Intervention descriptions: intervention 1: Oral istradefylline (KW-6002) 20 or 40 mg once daily.

Protocol documents:
Clinical trial NCT00282568
Conditions: Kidney Transplantation
Keywords: Pharmacokinetics Therapy Immunosuppression Drugs, Investigational Adult
Sponsor: Astellas Pharma Inc
Start date: 2002-08-01; Completion date: 2008-10-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Detailed description:
This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Arms: arm 1: Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
Interventions: intervention 1: Tacrolimus Modified Release (MR) intervention 2: tacrolimus
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT00295633
Conditions: Diabetes Mellitus, Type 2
Sponsor: AstraZeneca
Start date: 2006-03-01; Completion date: 2008-10-01
Enrollment: 565 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

Detailed description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (defined as rescue medication) added onto their blinded study medication

Arms: arm 1: Saxagliptin PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication) arm 2: Saxagliptin PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication) arm 3: Placebo PLUS pioglitazone OR rosiglitazone

PLUS open-label metformin (as needed as rescue medication)
Interventions: intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Placebo intervention 4: pioglitazone intervention 5: rosiglitazone intervention 6: metformin
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT) intervention 2: Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT) intervention 3: Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT) intervention 4: Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) intervention 5: Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) intervention 6: Tablets, Oral, 500-2500 mg, as needed (12 months LT)

Protocol documents:
Clinical trial NCT00308737
Conditions: Diabetes, Type 1 Diabetes, Type 2
Sponsor: Mannkind Corporation
Start date: 2005-06-01; Completion date: 2008-10-01
Enrollment: 2053 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pulmonary Safety in Diabetics with T/I

Detailed description:

Arms: arm 1: Technosphere® Insulin Inhalation Powder arm 2: Usual care arm 3: Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)
Interventions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Usual Care
Intervention descriptions: intervention 1: Inhalation, 15U/30U intervention 2: Subjects will receive antidiabetes treatment at the discretion of their physicians

Protocol documents:
Clinical trial NCT00489736
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation sinus rhythm amiodarone
Sponsor: Sanofi
Start date: 2007-06-01; Completion date: 2008-10-01
Enrollment: 504 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

Detailed description:

Arms: arm 1: dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg arm 2: over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets
Interventions: intervention 1: dronedarone (SR33589) intervention 2: amiodarone
Intervention descriptions: intervention 1: oral administration intervention 2: oral administration

Protocol documents:
Clinical trial NCT00496782
Conditions: HIV Infections
Keywords: Treatment Experienced
Sponsor: ViiV Healthcare
Start date: 2007-07-01; Completion date: 2008-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.

Detailed description:
The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Arms: arm 1: None
Interventions: intervention 1: maraviroc intervention 2: Trofile Assay and HIV RNA quantification assay
Intervention descriptions: intervention 1: Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID. intervention 2: Trofile Assay and HIV RNA quantification assay

Protocol documents:
Clinical trial NCT01214720
Conditions: Pancreatic Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-07-01; Completion date: 2008-10-01
Enrollment: 607 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin]
Intervention descriptions: intervention 1: Intervenous repeating dose

Protocol documents:
Clinical trial NCT01561898
Conditions: Schizophrenia
Keywords: Schizophrenia JNS007ER Paliperidone extended-release
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2006-06-01; Completion date: 2008-10-01
Enrollment: 228 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients with schizophrenia over a long term period.

Detailed description:
This is a 48-week, multicenter, open-label (all people know the identity of the intervention), non-controlled, arbitrary-dose study. The patients included in this study are those who participated in the preceding double-blind (neither physician nor patient knows the treatment that the patient receives) comparative trial (study JNS007ER-JPN-S31) of JNS007ER and completed the study, or those who remained in the study up to the evaluation at 2 weeks and discontinued the study after that for insufficient treatment efficacy. The study will assess the safety of JNS007ER in the clinical recommended dose range in a long term treatment. The dosage will be started at 6 mg/day, and it can be increased or decreased 3 mg at a time depending on the patient's symptom within the range of 3 mg/day to 12 mg/day. For dose adjustments, the investigator will evaluate the psychiatric symptoms before defining the dose change.

Detailed Description: Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone extended-release (JNS007ER)
Intervention descriptions: intervention 1: Type= range, unit= mg, number= 3-12, form= tablet, route= oral use. JNS007ER within the range of 3, 6, 9 and 12 mg will be orally administered once daily for 48 weeks.

Protocol documents:
Clinical trial NCT00003537
Conditions: Adult Brain Tumor
Keywords: adult anaplastic astrocytoma
Sponsor: Burzynski Research Institute
Start date: 1995-04-01; Completion date: 2008-10-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in adults with anaplastic astrocytoma 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 adults with anaplastic astrocytoma.

OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma 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 an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00056160
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Refractory and Relapsed Revlimid CC5013
Sponsor: Celgene
Start date: 2003-01-01; Completion date: 2008-10-01
Enrollment: 353 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

Detailed description:
This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

Arms: arm 1: CC-5013 (lenalidomide) plus oral high-dose dexamethasone arm 2: Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Interventions: intervention 1: CC-5013 intervention 2: Dexamethasone
Intervention descriptions: intervention 1: Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle. intervention 2: Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

Protocol documents:
Clinical trial NCT00078754
Conditions: Intermittent Explosive Disorder
Sponsor: University of Chicago
Start date: 2003-05-01; Completion date: 2008-10-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).

Detailed description:
IED is a condition characterized by a failure to resist aggressive impulses. IED is a behavioral defined condition for which effective treatments have not been identified. Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions, may play a role in the response to pharmacological IED treatments. This study will examine the relationship between 5-HT receptors and response to treatment with fluoxetine or divalproex. In addition, this study will examine people with IED and those without the condition to determine whether there are differences in their 5-HT receptor and transporter systems.

Participants in this study will be randomly assigned to receive either fluoxetine, divalproex, or placebo for 12 weeks. Scale ratings will be used to assess the aggression levels of participants. Biologic evaluations of the 5-HT system will be conducted throughout the study.

Arms: arm 1: Participants will to receive treatment with fluoxetine for 12 weeks arm 2: Participants will to receive treatment with divalproex for 12 weeks arm 3: Participants will to receive treatment with placebo for 12 weeks
Interventions: intervention 1: Fluoxetine intervention 2: Divalproex intervention 3: Placebo
Intervention descriptions: intervention 1: Fluoxetine capsules by mouth, up to 60 mg daily intervention 2: Divalproex ER capsules by mouth, up to 3000 mg daily intervention 3: Placebo capsules by mouth, up to 8 capsules daily

Protocol documents:
Clinical trial NCT00087633
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2004-10-01; Completion date: 2008-10-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. The anticipated time on study treatment was 3-12 months, and the target sample size was 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: Copegus
Intervention descriptions: intervention 1: 135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks intervention 2: 400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks

Protocol documents:
Clinical trial NCT00093145
Conditions: Breast Cancer
Keywords: Advanced Breast Cancer
Sponsor: Celgene
Start date: 2004-06-01; Completion date: 2008-10-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

Detailed description:

Arms: arm 1: Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
Interventions: intervention 1: Albumin-bound paclitaxel intervention 2: Carboplatin intervention 3: Herceptin®
Intervention descriptions: intervention 1: Administered by intravenous infusion. intervention 2: Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity. intervention 3: Administered by IV infusion

Protocol documents: