ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00475852
Conditions: Heart Decompensation
Keywords: Heart Decompensation Dyspnea Heart failure Nesiritide Decompensated ADHF
Sponsor: Scios, Inc.
Start date: 2007-05-01; Completion date: 2011-03-01
Enrollment: 7141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if nesiritide (a human B-type natriuretic peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart failure, helps to improve breathing difficulties, reduce heart failure readmissions to hospitals, and helps patients live longer.

Detailed description:
Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity. ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body. This is a randomized (study medication is assigned by chance), double-blind (neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo \[does not contain study drug\]), placebo-controlled, parallel group, multicenter study of the effectiveness of nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days. The study hypothesis is that nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties (by patient evaluation utilizing a breathlessness scale) at 6 hours or 24 hours after nesiritide administration, and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30. The study drug (nesiritide) or placebo dose being studied is 0.010 mcg/kg/min with or without a 2 mcg/kg initial bolus (one time injection) of nesiritide. Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects. The patients assigned to the nesiritide group will receive a continuous intravenous (into a vein) infusion at 0.010 mcg/kg/min of nesiritide with or without a 2 mcg/kg bolus (one time injection). The patients assigned to the placebo group will receive matching placebo bolus and infusion. The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days.

Arms: arm 1: Nesiritide 0.01 mcg/kg/min intravenous (IV) infusion (with or without 2 mcg/kg bolus) for 24 to 168 hours (hrs) arm 2: Placebo matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Interventions: intervention 1: Nesiritide intervention 2: Placebo
Intervention descriptions: intervention 1: 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs intervention 2: matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs

Protocol documents:
Clinical trial NCT00484679
Conditions: Alopecia Areata
Sponsor: University of Minnesota
Start date: 2007-05-01; Completion date: 2011-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to see whether treating alopecia areata with injections of the corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal glands.

Detailed description:
1. To determine the effects of intralesional Triamcinolone Acetonide 10mg/cc (Kenalog 10) use for the treatment of alopecia areata on adrenal function.
2. To evaluate the efficacy of intralesional corticosteroids (Kenalog-10)on hair regrowth in moderate to severe alopecia areata.

18 subjects with moderate to severe alopecia areata were enrolled and 15 subjects completed all study visits.

Subjects underwent intralesional triamcinolone acetonide (10mg/cc) (Kenalog-10) injections every 6 weeks for a period of 6 months in the General Clinical Research Center (GCRC). This period was followed by a 6 week, injection-free, safety follow-up visit. Adrenal function was assessed by utilization of the Low Dose Adrenocorticotropic Hormone Stimulation Test (ACTH) which measures adrenal gland production of cortisol after exogenously administered ACTH. Serum blood draws of 3 mL were done at baseline and 6-week intervals at the start of each scheduled appointment for intralesional treatment at approximately 0800 hours. Two blood draws were taken at time 0 and again 30 minutes after a 1 mcg bolus dose of synthetic ACTH (Cortrosyn).

Patients underwent their scheduled course of intralesional corticosteroid (Kenalog-10) injections and other study data was collected, such as SALT scores and physician assessments of AA, during the time between blood draws.

Arms: arm 1: Patients receiving Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections.
Interventions: intervention 1: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Intervention descriptions: intervention 1: Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection

Protocol documents:
Clinical trial NCT00501631
Conditions: Alcohol Dependence
Keywords: Addiction Alcoholism Inpatient detoxification
Sponsor: Alkermes, Inc.
Start date: 2007-07-01; Completion date: 2011-03-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

Detailed description:
The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.

Arms: arm 1: Administered via intramuscular (IM) injection once every 4 weeks. arm 2: Administered via IM injection once every 4 weeks.
Interventions: intervention 1: VIVITROL 380 mg intervention 2: Placebo for VIVITROL 380 mg
Intervention descriptions: intervention 1: Administered via IM injection once every 4 weeks. intervention 2: Administered via IM injection once every 4 weeks.

Protocol documents:
Clinical trial NCT00503906
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer
Sponsor: University of Miami
Start date: 2007-06-01; Completion date: 2011-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.

Detailed description:
This is a phase 2, single arm study. Participants will be treated with combination Gemzar, Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.

Arms: arm 1: Each treatment cycle is 28 days. Participants will be treated until disease progression:

* Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
* Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
Interventions: intervention 1: Avastin intervention 2: Gemcitabine intervention 3: Abraxane
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00511810
Conditions: Major Depressive Disorder
Keywords: Sadness Insomnia Loss of appetite Fatigue Trouble thinking
Sponsor: University of Cincinnati
Start date: 2007-08-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to determine the effects of 10-week adjunctive supplementation with 2 doses of LCn-3 fatty acids (fish oil) on cortical functional activity and biochemistry in adolescents with MDD.

The primary prediction was that LCn-3 fatty acid supplementation would dose-dependently increase prefrontal cortical functional activation during sustained attention and increase regional biochemical indices of cortical metabolism and integrity concentrations in association with reductions in depressive symptoms.

Detailed description:
This study is a 10-week open-label EPA+DHA treatment trial in adolescent (aged 12-18 years) patients with major depressive disorder exhibiting partial response to SSRI medications. After a screening visit, patients were randomized (stratified by gender) to open-label fish oil supplements at a fixed dose of either 2.4 g/day or 15 g/day (2 tablespoons/day) for 10 weeks.

A physical examination, a complete blood count (CBC), and thyroid stimulating hormone (TSH) levels were determined at baseline and Week 10, and vital signs (pulse, blood pressure, weight, height, body mass index, temperature) were obtained at each visit. At each visit, safety and tolerability were assessed using a structured side effect interview, the Side Effects Form for Children and Adolescents.

At baseline and all weekly visits, depression symptom severity was determined with the Children's Depression Rating Scale-Revised (CDRS-R), a 17-item observer-rated questionnaire, and remission was defined as a CDRS-R score of ≥28. If a patient's depressive symptoms worsened over the course of the trial (defined as 30% worsening relative to baseline on two consecutive visits using CDRS-R scores), they were withdrawn from the study. In view of the potential risk for developing hypomanic symptoms following LCn-3 fatty acid supplementation, manic symptom severity was monitored over the course of the trial with the Young Mania Rating Scale (YMRS), an 11-item observer-rated questionnaire.

fMRI scans were performed at baseline and at 10 weeks.

Arms: arm 1: Capsule omega-3 fatty acids 2.4g/day (4 capsules/day) arm 2: Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)
Interventions: intervention 1: Low Dose Fish Oil intervention 2: High Dose Fish Oil
Intervention descriptions: intervention 1: Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day) intervention 2: Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)

Protocol documents:
Clinical trial NCT00526656
Conditions: Bladder Cancer
Keywords: transitional cell carcinoma of the bladder stage II bladder cancer stage III bladder cancer stage IV bladder cancer
Sponsor: Case Comprehensive Cancer Center
Start date: 2007-09-01; Completion date: 2011-03-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with locally advanced bladder cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the pathologic complete response rate of sunitinib malate in patients with muscle-invasive locally advanced transitional cell carcinoma (TCC) of the bladder.
* To evaluate the safety and tolerability of sunitinib malate administered prior to radical cystectomy, including surgical outcome and surgical complications.

Secondary

* To determine the clinical effects of sunitinib malate administered prior to radical cystectomy and bilateral lymph node dissection, including overall response rate using RECIST defined criteria, cytology, and histologic appearance of surgical specimen as well as time to progression.

Tertiary

* To assess pre-treatment tissue baseline angiogenic markers and to evaluate the magnitude of the difference among these variables with post-treatment tumor tissue after neoadjuvant sunitinib malate.
* To evaluate the effects of sunitinib malate on immunosuppressive regulatory T cells.

OUTLINE: Patients receive oral sunitinib malate once daily in weeks 1-4 (1 course). Patients undergo restaging within 1 week prior to surgery and then undergo radical cystectomy and bilateral lymph node dissection on day 42. Patients achieving a complete pathologic response at the time of surgery may receive 6 more courses of adjuvant sunitinib malate beginning 28 days after surgery at the discretion of the treating physician. Patients found to have high-risk features (i.e. pT3 or greater tumor and evidence of disease in any of the lymph nodes resected) are offered standard adjuvant systemic chemotherapy at the discretion of the treating physician.

Tumor tissue from pretreatment biopsy and radical cystectomy will be tested for VEGFR-1, VEGFR-2 and PDGF-R expression by IHC. Samples are also analyzed for quantification of cell proliferation and apoptosis and immunosuppressive regulatory T cells (T-reg) and T-reg functions.

After completion of study treatment, patients are followed at 28 days after surgery.

Arms: arm 1: Drug
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: 50mg PO daily 4 weeks on -2 weeks off

Protocol documents:
Clinical trial NCT00527618
Conditions: Genital Herpes HIV Infection
Keywords: Herpes Simplex Virus Type 2 Human Immunodeficiency Virus Treatment Naive
Sponsor: University of Washington
Start date: 2007-12-01; Completion date: 2011-03-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that high-dose valacyclovir will result in greater reduction in plasma HIV-1 and genital HSV reactivation.

Detailed description:
We propose to conduct a randomized, open-label, cross-over study of 38 individuals who are HIV-1 seropositive and HSV-2 seropositive. Both men and women will be recruited for the study. Participants must not be on antiretroviral therapy and must not be planning to initiate antiretroviral therapy during the anticipated study period. Participants will be randomized 1:1 to receive acyclovir 400 mg twice daily or valacyclovir 1000 mg twice daily. After 12 weeks on the initial treatment, each participant will be crossed over to the alternative treatment arm for 12 weeks. The treatment periods will be separated by a 2-week washout period. During the first four weeks of each treatment period (i.e. weeks 1-4 and weeks 15-18), participants will provide self-collected genital swabs daily for HSV DNA quantification. Each week during the entire study period plasma samples will be collected from participants for HIV-1 RNA quantification.

Open-label acyclovir and valacyclovir will be used for this trial, as the primary outcome measures (genital HSV and plasma HIV-1) are unlikely to be influenced by knowledge of treatment assignment. However, laboratory staff performing plasma HIV-1 and genital HSV measurements will not be aware of treatment assignment.

Optional Sub-Study A: Sub-study A will be offered to study participants. The purpose of sub-study A is to measure the effect of valacyclovir twice daily on plasma HIV-1 replication.

Arms: arm 1: acyclovir 400 mg orally twice daily for 12 weeks. arm 2: valacyclovir 1000 mg orally twice daily for 12 weeks.
Interventions: intervention 1: valacyclovir intervention 2: acyclovir
Intervention descriptions: intervention 1: valacyclovir 1000 mg orally twice daily for 12 weeks. intervention 2: acyclovir 400 mg orally twice daily for 12 weeks.

Protocol documents:
Clinical trial NCT00531817
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2007-10-01; Completion date: 2011-03-01
Enrollment: 619 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tocilizumab intervention 2: Placebo intervention 3: Permitted DMARDs
Intervention descriptions: intervention 1: Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions. intervention 2: Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions. intervention 3: As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.

Protocol documents:
Clinical trial NCT00558363
Conditions: Neoplasms, Prostate Prostate Cancer After a Radical Treatment
Keywords: Prostate Cancer AVODART PSA dutasteride PSADT Prostate specific antigen radical therapy doubling time
Sponsor: GlaxoSmithKline
Start date: 2007-11-01; Completion date: 2011-03-01
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial assessing the efficacy and safety of dutasteride in extending time to prostate specific antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage radiotherapy) with curative intent but who experience a biochemical failure (PSA rise) afterwards without signs or symptoms of metastases.

Detailed description:
A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent (ARTS - AVODART after Radical Therapy for prostate cancer Study)

Arms: arm 1: Patients will receive a 3-month supply of study drug or placebo. Patients will be instructed to take one capsule by mouth once daily. Study medication will be supplied at 3-month intervals during scheduled clinic visits for a total of 24 months. arm 2: Patients will receive a 3-month supply of study drug or placebo. Patients will be instructed to take one capsule by mouth once daily. Study medication will be supplied at 3-month intervals during scheduled clinic visits for a total of 24 months.
Interventions: intervention 1: Avodart intervention 2: placebo
Intervention descriptions: intervention 1: 0.5 mg administered orally once daily intervention 2: Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo

Protocol documents:
Clinical trial NCT00566254
Conditions: Epilepsy; Paediatric Partial Onset Seizures
Keywords: Epilepsy paediatric partial onset seizures
Sponsor: Eisai Inc.
Start date: 2008-12-01; Completion date: 2011-03-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.

Detailed description:
This will be a double-blind, randomised, study comparing zonisamide with placebo: each arm will consist of 102 subjects. Zonisamide/placebo dosing will commence with a dose of 1 mg/kg. Further dose increases will occur at weekly intervals until a dose of 8 mg/kg is reached at the end of Week 8. In the event of dose limiting adverse events (AEs), during the eight week Titration Period, one down titration to a lower dose is permitted, this can happen at any point in the Titration Period. Subjects who require further down titration steps will be withdrawn from the study. During the Maintenance Period the dose of study medication must remain unchanged.

Changes in concomitant AEDs are not permitted during the Screening, Titration or Maintenance Periods.

This trial consists of the following periods:

1. Screening Period (duration four weeks): once the Screening Visit has been performed, a seizure diary will be maintained to document the baseline seizure frequency in the eight weeks between the Screening Visit and the Randomisation Visit.
2. Titration Period (duration four weeks): during this period, zonisamide/placebo dosing will commence with a dose of 1 mg/kg. Further dose increases will occur at one week intervals until a dose of 8 mg/kg is reached at Visit 6 (Week 8). In the event of dose limiting AEs during the Titration Period, one down titration step to the previous dose will be permitted.
3. Maintenance Period (duration 12 weeks): during this period, randomised subjects will be treated with the dose of zonisamide/placebo which they were receiving at Visit 6 (Week 8). No changes to the dose are allowed during this phase.

Following the Maintenance Period subjects will have the opportunity to enter an open label extension study. This open label extension study will be the subject of a separate protocol and will not be discussed further at this time.

Arms: arm 1: Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8. arm 2: Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
Interventions: intervention 1: Zonisamide intervention 2: Placebo
Intervention descriptions: intervention 1: 8mg/kg per day for approximately 24 weeks. intervention 2: None

Protocol documents: