ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00507507
Conditions: Chronic Hepatitis B
Keywords: tenofovir monotherapy emtricitabine combination hepatitis B
Sponsor: Gilead Sciences
Start date: 2007-09-01; Completion date: 2012-08-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection.

The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters.

Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.

Detailed description:

Arms: arm 1: Participants were randomized to receive tenofovir DF plus placebo to match FTC once daily. arm 2: Participants were randomized to receive FTC plus tenofovir DF once daily.
Interventions: intervention 1: Tenofovir DF intervention 2: FTC intervention 3: Placebo
Intervention descriptions: intervention 1: Tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablet taken orally once daily intervention 2: Emtricitabine (FTC) 200 mg capsule taken orally once daily intervention 3: Placebo to match FTC taken once daily

Protocol documents:
Clinical trial NCT00515112
Conditions: Prostate Cancer
Keywords: prostate cancer testosterone replacement AndroGel prostatic cancer prostatic neoplasms
Sponsor: University of Chicago
Start date: 2007-07-01; Completion date: 2012-08-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.

Detailed description:
The primary objective of the study is to determine the effect of testosterone replacement on time to disease progression and time to clinical cancer progression.

The secondary objectives are to describe the effect of testosterone replacement on patient-reported quality of life (FACT-P, FACT-fatigue and specific measures from the Expanded Prostate Cancer Index (EPIC): Sexual and Hormonal Assessments), and hand-grip strength; to describe changes in total testosterone, free testosterone, and PSA levels; to explore AR levels in circulating tumor cells as a marker of treatment benefit.

Arms: arm 1: Twenty subjects will receive testosterone gel arm 2: Twenty subjects will receive the placebo
Interventions: intervention 1: AndroGel intervention 2: placebo
Intervention descriptions: intervention 1: Androgel 1%, 10g daily intervention 2: placebo

Protocol documents:
Clinical trial NCT00528788
Conditions: Hyperparathyroidism, Secondary Kidney Failure, Chronic
Sponsor: Duke University
Start date: 2007-09-01; Completion date: 2012-08-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.

Detailed description:

Arms: arm 1: ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive will receive doxercalciferol 2 mcg or 4 mcg 3 times per week fopr 30 days (1 month). Blood work and vascular laboratory studies will be performed pre and post treatment.
Interventions: intervention 1: doxercalciferol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00535002
Conditions: Cocaine Related Disorders
Keywords: Cocaine Addiction Cocaine Dependence
Sponsor: Medical University of South Carolina
Start date: 2007-09-01; Completion date: 2012-08-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Stress and cues reminiscent of cocaine use promote craving and relapse in cocaine dependent individuals. In addition, there appears to be gender differences in determinants of relapse to drug use following abstinence in cocaine-dependent individuals. Therefore the purpose of the present study is to study the role of hormonal status on the response to cocaine-related cues with or without stress in cocaine-dependent women and men.

Detailed description:
Cocaine dependence is an insidious disease underscored by a strong propensity to relapse despite knowledge of the repercussions of continued drug-use. Stress and cocaine cues produce craving and ultimately relapse in cocaine dependent individuals. Pre-clinical research has demonstrated sex differences in response to cocaine-conditioned cues and cocaine-primed reinstatement, which correlates well with reduced plasma progesterone levels. Interestingly, this is consistent with a growing body of clinical literature indicating that progesterone may decrease the reinforcing properties of stimulants in women. Gender differences in the response to a social stressor and cocaine cues in cocaine-dependent individuals have been demonstrated in human laboratory studies, however, the interaction of stress and cues and the effect of hormonal status on response have not been explored. This study examines the role of hormonal status on the response to cocaine-related cues with or without a pharmacological stressor (yohimbine) in cocaine-dependent women and men. As a further integration of the research focus this study also explores the relationship between impulsivity and craving.

Arms: arm 1: Cocaine dependent females, received yohimbine day 1 and placebo day 2 arm 2: Cocaine dependent females, received placebo day 1 and yohimbine day 2 arm 3: Cocaine dependent males, received yohimbine day 1 and placebo day 2 arm 4: Cocaine dependent males, received placebo day 1 and yohimbine day 2 arm 5: Non-dependent females, received yohimbine day 1 and placebo day 2 arm 6: Non-dependent females, received placebo day 1 and yohimbine day 2 arm 7: Non-dependent males, received yohimbine day 1 and placebo day 2 arm 8: Non-dependent males, received placebo day 1 and yohimbine day 2
Interventions: intervention 1: Yohimbine intervention 2: Placebo
Intervention descriptions: intervention 1: Participants were pre-treated with either yohimbine or placebo. intervention 2: None

Protocol documents:
Clinical trial NCT00544440
Conditions: Prostate Neoplasms
Keywords: Prostate neoplasms Prostate cancer Castration-resistant prostate cancer Abiraterone acetate CB7630 Prednisone Testosterone Bone marrow
Sponsor: Janssen Research & Development, LLC
Start date: 2007-10-01; Completion date: 2012-08-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the effect of abiraterone acetate on levels of androgens and steroid metabolites in bone marrow plasma of patients with metastatic castration-resistant prostate cancer (CRPC).

Detailed description:
This is a single-center, open-label (identity of assigned study drug will be known) study investigating the effect of abiraterone acetate on levels of testosterone and dihydrotestosterone (DHT) in bone marrow plasma of patients with metastatic CRPC and evaluating the difference in bone marrow androgen levels between patients with and without serum prostate specific antigen (PSA) decline. Approximately 60 medically or surgically castrated male patients with metastatic CRPC will be enrolled. The study will consist of screening, treatment, and follow-up periods. Patients will be treated orally (by mouth) with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression. Follow-up will continue until the patient dies, is lost to follow-up or withdraws informed consent. Bone marrow aspirates will be collected at Week 1 (predose), Week 9, and the final study visit. Safety will be monitored throughout the study.

Arms: arm 1: Patients will be treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
Interventions: intervention 1: Abiraterone acetate intervention 2: Prednisone
Intervention descriptions: intervention 1: Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily intervention 2: Prednisone 5 mg tablet taken orally twice daily

Protocol documents:
Clinical trial NCT00558272
Conditions: Breast Cancer Prostate Cancer Bone Neoplasms
Keywords: breast cancer prostate cancer metastatic bone disease Subjects with breast cancer or prostate cancer with metastatic bone disease
Sponsor: AstraZeneca
Start date: 2008-02-01; Completion date: 2012-08-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of AZD0530 on subjects with breast cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.

Detailed description:

Arms: arm 1: AZD0530 (saracatinib) 175 mg once daily arm 2: Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
Interventions: intervention 1: AZD0530 intervention 2: Zoledronic Acid
Intervention descriptions: intervention 1: Daily oral dose intervention 2: None

Protocol documents:
Clinical trial NCT00585247
Conditions: Port Wine Stain
Keywords: birthmarks
Sponsor: University of California, Irvine
Start date: 2006-11-01; Completion date: 2012-08-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Port wine stains are red birthmarks that without treatment persist for a lifetime. They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating Port wine stains is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the Laser treatment is likely an important factor in why these lesions persist despite therapy.

Detailed description:
Imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. It has been used to successfully treat other vascular growths such as hemangiomas. The research can use imiquimod cream 5% cream apply to port wine stains after laser therapy to improve lightening of port wine stains. The imiquimod 5% cream cream apply to Port wine stains everyday for 8 weeks.

Arms: arm 1: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks arm 2: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Interventions: intervention 1: Imiquimod intervention 2: Placebo
Intervention descriptions: intervention 1: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks intervention 2: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Protocol documents:
Clinical trial NCT00660504
Conditions: Lung Cancer
Keywords: Extensive Disease-Small Cell Lung Cancer
Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Start date: 2008-04-01; Completion date: 2012-08-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

Detailed description:

Arms: arm 1: Amrubicin Hydrochloride-Cisplatin combined chemotherapy arm 2: Etoposide-Cisplatin combined chemotherapy
Interventions: intervention 1: Amrubicin Hydrochloride intervention 2: Etoposide-Cisplatin combined chemotherapy
Intervention descriptions: intervention 1: Amrubicin Hydrochloride combined with cisplatin intervention 2: combined chemotherapy

Protocol documents:
Clinical trial NCT00718419
Conditions: Waldenstrom's Macroglobulinemia Multiple Myeloma
Keywords: Waldenstrom's Macroglobulinemia Multiple Myeloma
Sponsor: Eli Lilly and Company
Start date: 2008-07-01; Completion date: 2012-08-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Enzastaurin
Intervention descriptions: intervention 1: Enzastaurin: Cycle 1 Day 1 only: 3, 125-milligrams (mg) tablets three times on Day 1 (Day 1 total dose = 1125 mg)

Day 2 onwards and subsequent Cycles: 2, 125-mg tablets orally twice a day (500 mg total per day).

Cycle length (all cycles): 28 days. Patients may stay on drug past 8 cycles, (until the study is closed) or until disease progression.

Protocol documents:
Clinical trial NCT00721526
Conditions: Alcohol Dependence Anxiety Disorder
Keywords: alcohol dependence alcoholism anxiety disorder pharmacotherapy disulfiram lorazepam
Sponsor: University of New Mexico
Start date: 2009-08-01; Completion date: 2012-08-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The proposed design is a single-group open-label trial. Qualified consenting participants with active alcohol dependence and primary or secondary anxiety disorder will receive monitored disulfiram and lorazepam, in the context of a structured Medication Management (MM) model. In weeks 9-15 lorazepam is tapered, and disulfiram is stopped at the end of week 16. Participants who achieve 4 weeks abstinence and meet criteria for a primary anxiety disorder or mood disorder may receive ancillary medication consisting FDA-approved non-benzodiazepine treatment, with specific options for each disorder described in the protocol. Participants requiring continued treatment are referred to clinical treatment in the community at week 16, and bridging prescriptions of anxiolytic/antidepressant medication may be provided. A final follow-up assessment occurs at week 28. The primary outcomes are Percent Days Abstinent (PDA) and retention in treatment. Secondary alcohol outcomes are consequences, drinks per drinking day, remission status, and time to first heavy drinking day. Anxiety outcomes are Hamilton Anxiety Scale scores and anxiety disorder diagnosis.

Detailed description:

Arms: arm 1: Disulfiram plus lorazepam
Interventions: intervention 1: disulfiram plus lorazepam
Intervention descriptions: intervention 1: Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily

Protocol documents:
Clinical trial NCT00735670
Conditions: Spinal Cord Injury
Keywords: SCI
Sponsor: University of Michigan
Start date: 2008-06-01; Completion date: 2012-08-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.

Detailed description:
The successes of psychological and pharmacological modes of intervention in treating depression, both alone and combined, are well documented in the literature. While a great deal of research has identified specific clinical indications for many antidepressants currently available in the general population, little is known about the clinical indications of these agents in SCI. This study is proposed to test the benefits of Venlafaxine HCI (Effexor XR) for reducing mild to moderate symptoms of depression among people with SCI. The intervention will last 12 weeks and there will be 13 assessments and data collection points. Data will be collected at 26 weeks also. Eight face to face contacts are anticipated.

Because of the change in protocol to reducing mild to moderate symptoms and substantially lower enrollment than anticipated (1/6th of what we anticipated), we deleted a number of study outcomes listed in the 2011 posting of this study. Most of these were not part of the original posting in 2008, and those that were deleted were no longer relevant to new protocol's focus on reducing mild to moderate depression. The two outcomes reported here were most relevant to the revised protocol.

Arms: arm 1: Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber. arm 2: Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
Interventions: intervention 1: Venlafaxine HCl intervention 2: Placebo
Intervention descriptions: intervention 1: Starting dose is 37.5 mg and ending dose is 150 mg at 13 weeks. From weeks 13 to 26 subjects no longer will receive the drug intervention 2: Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.

Protocol documents:
Clinical trial NCT00736229
Conditions: Hyperglycemia Acute Coronary Syndromes Myocardial Infarction
Keywords: hyperglycemia acute coronary syndromes myocardial infarction
Sponsor: Saint Luke's Health System
Start date: 2008-08-01; Completion date: 2012-08-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.

Detailed description:
Diabetic patients with acute myocardial infarction (MI) have particularly poor outcomes. Clinical practice guidelines from the American College of Cardiology/American Heart Association for the treatment of patients with acute coronary syndromes call for treatment to achieve preprandial glucose \<110 mg/dL, a maximum daily target \<180 mg/dL, and a post-discharge hemoglobin A1c \<7%. Initiation of aggressive insulin therapy is also warranted to achieve blood glucose \<150 mg/dL during days 0-3 and 80-110 mg/dL when possible thereafter. To date, no studies have been conducted assessing the efficacy of intravenous exenatide administration on achieving glucose lowering in hyperglycemic coronary ICU patients.

Arms: arm 1: 0.05 µg/min liquid bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours
Interventions: intervention 1: Exenatide
Intervention descriptions: intervention 1: 0.05 µg/min bolus of open-label exenatide followed by a constant infusion of 0.025 µg/min for 24-48 hours

Protocol documents:
Clinical trial NCT00744757
Conditions: Myelodysplastic Syndrome
Keywords: 5-aza-2'-deoxycytidine decitabine dacogen Myelodysplastic Syndrome
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2008-08-01; Completion date: 2012-08-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the response rate of decitabine in previously treated and untreated Taiwanese participants with Myelodysplastic Syndrome (MDS - a disease associated with decreased production of blood cells, blood cells are produced but do not mature normally).

Detailed description:
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), multi-center (when more than 1 hospital or medical school team work on a medical research study), single-arm study of decitabine. The study will consist of 5 phases: Pre-treatment phase (before 30 days of first dose), Treatment phase (consist of 8 cycles, each cycle of 28 days), End-of-treatment phase (consist of 30-42 days after the last dose of cycle 8, or at time of discontinuation), Extension phase (1 cycle of 4 weeks) and Post-study phase or follow-up phase (every 2 months until 1 year, lost to follow-up or death). Participants who achieve a complete remission (when a medical problem gets better or goes away at least for a while) will be treated for at least 2 more cycles after first documentation of complete response (CR), after which treatment can be discontinued. Decitabine in a dose of 20 milligram per square meter (mg per m\^2) will be administered intravenously over 1 hour infusion, 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity. The primary objective is to evaluate the best response rate (complete response and partial response). Participants' safety will be monitored throughout the study.

Arms: arm 1: Decitabine 20 milligram per square meter (mg per m\^2) will be administered intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.
Interventions: intervention 1: Decitabine
Intervention descriptions: intervention 1: Decitabine 20 mg per m\^2 will be administered intravenous infusion over 1 hour, once daily for 5 consecutive days of a 28 days cycle up to 8 cycles or continued until disease progression or unacceptable toxicity.

Protocol documents: