ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00414635
Conditions: HIV Infections
Keywords: HIV/AIDS efavirenz tenofovir emtricitabine FOTO treatment interruption Atripla Truvada Treatment Experienced
Sponsor: Community Research Initiative of New England
Start date: 2006-08-01; Completion date: 2009-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
For people with HIV who are currently taking specific medications (including Sustiva (efavirenz)) and have no detectable viral load, this study tracks how patients do if they take their medications for five days of the week compared with seven days of the week.

Detailed description:
The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of treatment followed by two days off treatment versus continuous treatment with the same regimen. This is a larger study based on the results of our successful pilot study using the same protocol. The 48 week, phase IV trial addresses the issues of the high cost of HIV treatment, adherence problems associated with daily treatment, and cumulative toxicities. Virologic and immunologic parameters, drug levels of efavirenz, adherence, and toxicity will be measured. Subjects will have to be seen at CRI for 6 visits after randomization. Subjects randomized to daily therapy will cross over to 5/2 therapy at 24 weeks if their viral load remains undetectable.

Arms: arm 1: Subjects randomized to the control arm will remain on daily dosing of the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mouth daily for 24 weeks. After 24 weeks of daily therapy subjects on this arm may be eligible to cross over to the experimental arm regimen of the coformulated single tablet of 600 mg efavirenz +300 mg tenofovir df +200 mg of emtricitabine on the 5/2 intermittent dosing treatment schedule for the remainder of the study. arm 2: Subjects randomized to the 5/2 intermittent dosing treatment schedule regimen will be prescribed the pre-study regimen of 600mg efavirenz and 1 coformulated tablet of 300mg tenofovir df + 200 mg emtricitabine by mouth daily, or the equivalent coformulated single tablet of 600mg efavirenz + 300mg tenofovir df + 200 mg emtricitabine by mouth daily, for 5 consecutive days per week followed by 2 days off of these medications, 600 mg efavirenz, 300 mg tenoforvir dt and 200 mg emtricitabine, for 48 weeks.
Interventions: intervention 1: Intermitent Dosing
Intervention descriptions: intervention 1: Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. .

Protocol documents:
Clinical trial NCT00414908
Conditions: Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency
Keywords: Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency
Sponsor: Solvay Pharmaceuticals
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pancrelipase delayed release capsule intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: 24,000 unit capsule intervention 2: Placebo

Protocol documents:
Clinical trial NCT00416793
Conditions: Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-12-01; Completion date: 2009-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with carboplatin may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in patients who previously received 1 prior regimen for metastatic pancreatic cancer.

SECONDARY OBJECTIVES:

I. To evaluate the objective tumor response rate, the duration of response, time to tumor progression, and overall survival.

II. To evaluate biological effects on peripheral blood mononuclear cells. III. To evaluate the safety profile of this combination. IV. To evaluate archival tissue for epithelial-to-mesenchymal transition (EMT) and E-cadherin and Zeb-1.

OUTLINE:

Patients receive bortezomib intravenously (IV) on days 1, 4, 8, and 11 and carboplatin intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Arms: arm 1: Patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: bortezomib intervention 2: carboplatin intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00424021
Conditions: Pulmonary Hypertension
Sponsor: Gilead Sciences
Start date: 2003-04-01; Completion date: 2009-12-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, "A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension".

Detailed description:

Interventions: intervention 1: ambrisentan
Intervention descriptions: intervention 1: 1, 2.5, 5, and 10 mg ambrisentan given orally once daily

Protocol documents:
Clinical trial NCT00434876
Conditions: Alcoholism Sleep Initiation and Maintenance Disorders
Keywords: Alcoholism Insomnia Quetiapine Seroquel
Sponsor: Subhajit Chakravorty
Start date: 2007-08-01; Completion date: 2009-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in improving the sleep in recovering alcohol dependent subjects.

Detailed description:
Sober alcohol dependent subjects frequently complain of difficulty falling asleep as well as staying asleep which may eventually lead to relapse. Novel antipsychotic medications such as quetiapine have shown some efficacy in treating alcoholism and have also shown some benefit in improving insomnia.

The primary aim of this study is to determine the degree to which quetiapine improves sleep in veterans during the early phase of recovery from alcohol dependence. The sleep efficiency from an in-lab polysomnogram will be the primary outcome measure. Secondary measures of sleep will include the Pittsburgh Sleep Quality Index, Insomnia Severity Index, and actigraphy. Other additional aims will explore for alcohol use and cravings, change in psychiatric symptoms using the The Time Line Follow Back measure, Penn Alcohol Craving Scale (PACS), the Patient Health Questionnaire-9 item scale (PHQ-9), and the Beck's Anxiety Inventory (BAI) respectively.

Twenty four subjects within the first year of sobriety will be enrolled. Participants will be undergo an extensive baseline screening procedure. After 2 consecutive in-laboratory polysomnograms they will be treated with either Quetiapine XR or matching placebo pills targetting a dose of 400 mg a night. The treatment duration will be 8 weeks and during the eight week of treatment they will undergo 2 more nights of in-laboratory polysomnogram. All subjects will also receive Medical Management therapy, a standardized psychosocial intervention which is medically-based and focusses on alcohol abstinence and medication compliance.

Arms: arm 1: Quetiapine XR arm 2: Placebo
Interventions: intervention 1: Quetiapine XR intervention 2: Placebo.
Intervention descriptions: intervention 1: Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder. intervention 2: Inactive or inert pill which will be used as a comparator.

Protocol documents:
Clinical trial NCT00443079
Conditions: Fatty Liver
Keywords: Clinical Trials Pilot Projects Milk Thistle Liver Function Tests
Sponsor: Heather Patton
Start date: 2007-03-01; Completion date: 2009-12-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the dietary supplement Siliphos, which comes from milk thistle, to determine whether it is safe and well-tolerated in adults who have non-alcoholic steatohepatitis (NASH). An additional aim of this study is to determine whether Siliphos may be beneficial in treatment of NASH as indicated by improvement in liver enzymes (ALT and AST). The study hypothesis is that Siliphos will be safe and well-tolerated in people with NASH and will result in a decrease in the liver enzymes ALT and AST.

Detailed description:
Non-alcoholic fatty liver disease (NAFLD) encompasses a spectrum of liver conditions characterized by fat accumulation in the liver. Non-alcoholic steatohepatitis (NASH) is one form of NAFLD that may progress to cirrhosis in some people. Currently, there are no medications that are approved for the treatment of NASH. Milk thistle is sold over-the-counter as a dietary supplement. Milk thistle has been used for hundreds of years as a supplement to support liver function, and is commonly taken by people with a variety of liver conditions. Milk thistle may help to reduce inflammation and fibrosis (scar tissue) in the liver, so it may be beneficial in the treatment of NASH. As NAFLD is very common in the population, there are probably many people with NAFLD taking milk thistle supplements. However, there are no published studies of milk thistle in NAFLD. Therefore, this study is designed to provide preliminary evidence of the safety, tolerability, and efficacy of milk thistle in people with NASH.

Comparison: The milk thistle supplement (called Siliphos) will be compared to a placebo (sugar pill) in this study.

Arms: arm 1: Received study medication first followed by placebo arm 2: Received placebo first followed by study medicaiton
Interventions: intervention 1: IdB 1016 (Siliphos) intervention 2: Matched placebo
Intervention descriptions: intervention 1: 1 pill 3 times daily x 6 weeks intervention 2: 1 pill 3 times daily x 6 weeks

Protocol documents:
Clinical trial NCT00449150
Conditions: Benign Prostatic Hypertrophy
Keywords: Cetrorelix
Sponsor: AEterna Zentaris
Start date: 2007-03-01; Completion date: 2009-12-01
Enrollment: 667 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

Detailed description:
The objectives of the study are to develop a safe and tolerable intermittent dosage regimen of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.

Patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).

Patients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion.

Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will be followed up to Week 52.

Then, in an open label fashion, patients will be administered an IM injection of study drug at Week 52, 54, 78 and 80 and will be followed up to Week 90.

Arms: arm 1: Treatment course 1: Cetrorelix 78 mg + 78 mg

* Week 0: 52 mg CET (2 injections)
* Week 2: 26 mg CET (1 injection)

Treatment course 2:

* Week 26: 52 mg CET (2 injections)
* Week 28: 26 mg CET(1 injection)

  4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient. arm 2: Treatment course 1: Cetrorelix 78 mg + 52 mg

* Week 0: 52 mg CET (2 injections)
* Week 2: 26 mg CET (1 injection)

Treatment course 2:

* Week 26: 52 mg CET (2 injections)
* Week 28: Placebo (1 injection)

  4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient. arm 3: Treatment course 1:

* Week 0: placebo (2 injections)
* Week 2: placebo (1 injection)

Treatment course 2:

* Week 26: placebo (2 injections)
* Week 28: placebo (1 injection)

  4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.
Interventions: intervention 1: Cetrorelix 78 mg + 78 mg intervention 2: Cetrorelix 78 mg + 52 mg intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00451191
Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia BPH botulinum toxin BoNT/A
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2006-10-01; Completion date: 2009-12-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind randomized phase II trial to determine whether two different doses of BoNT/A injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. Subjects will receive either a 100U or 300U dose. Participation will last 1 year.

Detailed description:

Arms: arm 1: 100 units botulinum toxin type A (BoNT/A) arm 2: 300 units botulinum toxin type A (BoNT/A)
Interventions: intervention 1: botulinum toxin type A (BoNT/A)
Intervention descriptions: intervention 1: 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.

Protocol documents:
Clinical trial NCT00454532
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer Bionovo BZL101 Chinese Herbs
Sponsor: Bionovo
Start date: 2007-03-01; Completion date: 2009-12-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
BZL 101 is an aqueous extract from herba Scutellaria Barbata D. Don of the Lamiaceae family. Preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinical data suggest that it is tolerable in patients with metastatic breast cancer. The overall goals of this Phase I/II trial are to assess the toxicity, maximum tolerated dose, safety and preliminary efficacy of BZL101 for the treatment of advanced metastatic breast cancer.

Detailed description:

Interventions: intervention 1: BZL101
Intervention descriptions: intervention 1: Freeze dried powder mixed with liquid. Administered as a daily dose. Dosage to be determined in Phase 1 portion.

Protocol documents:
Clinical trial NCT00462761
Conditions: Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome AML MDS
Keywords: RTK kinase inhibitor tyrosine acute FLT3 AC220 pharmacokinetic pharmacokinetics PK pharmacodynamic pharmacodynamics mutations PD receptor class III relapsed refractory t(8;21) q22;q22 AML1/ETO t(16;16 p13;q22 CBFbeta/MYH11 inv(16) p13q22 11q23 dysplasia myeloid myelomonocytic monoblastic monocytic erythroid erythroleukemia megakaryoblastic basophilic panmyelosis myelofibrosis
Sponsor: Daiichi Sankyo
Start date: 2007-01-01; Completion date: 2009-12-01
Enrollment: 76 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.

Detailed description:
This is a multi-center clinical study conducted in the USA and two international sites. This open-label, dose escalation study was designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered AC220 as a single agent given daily for 14 days. Cohorts of 3 patients received AC220 until dose limiting toxicity was noted (DLT). At that point cohorts expanded to 6 patients until MTD was determined. Patients not experiencing DLT or significant disease progression at Day 15 may have continued receiving AC220 at the discretion of the Investigator and Sponsor. FLT3 positive and negative patients were allowed to participate.

Arms: arm 1: Determine safety, tolerability and pharmacokinetic (PK) parameters of AC220
Interventions: intervention 1: AC220
Intervention descriptions: intervention 1: Powder in bottle formulation supplied as 50mg or 350 mg in glass, crimped serum vials. Requires reconstitution by a pharmacist, and must be stored securely and protected from light.

Protocol documents:
Clinical trial NCT00470067
Conditions: Endometrial Cancer
Keywords: recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma
Sponsor: Roswell Park Cancer Institute
Start date: 2007-02-01; Completion date: 2009-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and carboplatin, 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 doxorubicin hydrochloride liposome together with carboplatin works in treating patients with recurrent, stage III, or stage IV primary endometrial cancer.

Detailed description:
OBJECTIVES:

Primary

* Estimate the response rate in patients with recurrent or stage III or IV primary endometrial carcinoma treated with doxorubicin hydrochloride liposome and carboplatin.

Secondary

* Determine progression-free survival of patients treated with this regimen.
* Determine overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Arms: arm 1: Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
Interventions: intervention 1: carboplatin intervention 2: pegylated liposomal doxorubicin hydrochloride
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol documents:
Clinical trial NCT00472641
Conditions: Bipolar Disorder
Sponsor: Stanford University
Start date: 2007-01-01; Completion date: 2009-12-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This research study is designed to determine if replacing your current antipsychotic and/or mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to be an effective medication for overweight or obese patients with bipolar disorder. There will be approximately 25 patients enrolled in this study.

Detailed description:

Arms: arm 1: Ziprasidone/Geodon up to 320 mg per day
Interventions: intervention 1: Ziprasidone/Geodon
Intervention descriptions: intervention 1: Ziprasidone/Geodon

Protocol documents:
Clinical trial NCT00476645
Conditions: Prostatic Neoplasms Prostate Cancer
Sponsor: Stanford University
Start date: 2006-09-01; Completion date: 2009-12-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).

Detailed description:
The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.

Arms: arm 1: None
Interventions: intervention 1: Fulvestrant
Intervention descriptions: intervention 1: Fulvestrant 250 mg IM on Days 1 and 14 in the first month, thereafter 250 mg monthly

Protocol documents: