ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00797966
Conditions: Major Depressive Disorder
Keywords: OPC-34712, Major Depressive Disorder, Adjunctive Treatment
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2009-05-01; Completion date: 2010-07-01
Enrollment: 850 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.

Detailed description:
A comparison of the Fixed dose arm (OPC-31712, 0.15 mg) verses placebo was included as a general secondary efficacy variable and results for this dose group comparison are included under each of the Outcome Measures.

Arms: arm 1: OPC-34712 + ADT arm 2: Placebo + ADT
Interventions: intervention 1: OPC-34712 intervention 2: Placebo intervention 3: ADT
Intervention descriptions: intervention 1: Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks intervention 2: Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks intervention 3: Tablets, 10 - 225 mgs, dose once daily, 14 weeks

Protocol documents:
Clinical trial NCT00798317
Conditions: Vitreomacular Adhesion
Sponsor: ThromboGenics
Start date: 2008-12-01; Completion date: 2010-07-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.

Detailed description:

Arms: arm 1: 125µg of ocriplasmin intravitreal injection arm 2: Intravitreal injection of placebo
Interventions: intervention 1: Ocriplasmin 125µg intervention 2: Placebo
Intervention descriptions: intervention 1: 125µg of ocriplasmin intravitreal injection intervention 2: Intravitreal injection placebo.

Protocol documents:
Clinical trial NCT00801229
Conditions: Attention Deficit/Hyperactivity Disorder(ADHD)
Keywords: ADHD young adults driving Vyvanse lisdexamfetamine
Sponsor: Massachusetts General Hospital
Start date: 2008-12-01; Completion date: 2010-07-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the benefice of Vyvanse on the factors that cause impairments in driving behavior in individuals with ADHD using a driving simulation aimed at examining the factors that cause impairments in driving behavior in individuals with ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages 18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show lower velocity (speed) scores and spend less time driving over the posted speed limit in the driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser likelihood of driving through stop signs and solid red traffic lights without slowing down when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with Vyvanse will exhibit more focused visual attention on details in the visual field when compared to subjects taking a placebo while driving. In addition, young adults with ADHD treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when compared to subjects taking a placebo.

Detailed description:

Arms: arm 1: Patients may be randomized to the active comparator arm. Participants randomized to this arm will receive 30, 50, or 70mg Vyvanse daily. arm 2: Patients may be randomized to the placebo comparator arm. Those randomized to this arm will receive 30, 50, or 70mg placebo daily.
Interventions: intervention 1: Vyvanse intervention 2: Placebo
Intervention descriptions: intervention 1: Vyvanse 30, 50, or 70 mg daily intervention 2: Placebo 30, 50, 70 mg daily

Protocol documents:
Clinical trial NCT00803023
Conditions: Fibromyalgia
Sponsor: Jazz Pharmaceuticals
Start date: 2010-03-01; Completion date: 2010-07-01
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To compare the safety and tolerability of sodium oxybate given as a combination of an oral solution and oral tablets for 4 weeks in subjects with fibromyalgia (FM).

Detailed description:

Arms: arm 1: Sodium Oxybate Oral Solution (4.5 grams) arm 2: Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (4.5 grams) arm 3: Sodium Oxybate Oral Solution (6 grams) arm 4: Sodium Oxybate taken as a combination of an Oral Solution and Placebo Tablets (6 grams)
Interventions: intervention 1: Sodium Oxybate intervention 2: Sodium Oxybate & 6 Tablets intervention 3: Sodium Oxybate & 8 Tablets intervention 4: Sodium Oxybate Oral Solution (6 grams)
Intervention descriptions: intervention 1: 4.5 grams per night taken in two equally divided doses intervention 2: 4.5 grams taken as a combination of liquid and 6 Placebo tablets in two equally divided doses per night intervention 3: 6 grams taken as a combination of liquid and 8 Placebo tablets in two equally divided doses per night intervention 4: 6 grams per night taken in two equally divided doses

Protocol documents:
Clinical trial NCT00805766
Conditions: Crohn's Disease
Keywords: Infliximab REMICADE Crohn's disease
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-12-01; Completion date: 2010-07-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: TA-650
Intervention descriptions: intervention 1: (1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.

Protocol documents:
Clinical trial NCT00808405
Conditions: Genital Herpes
Keywords: herpes simplex virus acyclovir HSV shedding women Africa
Sponsor: University of Washington
Start date: 2009-01-01; Completion date: 2010-07-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: acyclovir intervention 2: matching placebo
Intervention descriptions: intervention 1: 400mg taken orally three times daily for 5 days intervention 2: matching placebo taken orally three times daily for 5 days.

Protocol documents:
Clinical trial NCT00815308
Conditions: Esophageal Cancer
Keywords: Therapeutic Drug Therapy, combination Radiotherapy
Sponsor: Shandong Cancer Hospital and Institute
Start date: 2009-01-01; Completion date: 2010-07-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation improve clinical outcomes.

Detailed description:
Esophageal cancer is the sixth leading cause of cancer death worldwide.

Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting.

Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer.

Accumulating clinical evidence suggests that epidermal growth factor receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Cetuximab, a monoclonal antibody, binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor (TGF)-α.

Preclinical models have suggested synergy between cetuximab, paclitaxel, cisplatin and radiation. For patients with locally advanced head and neck cancer, the combination of cetuximab and radiation has demonstrated both response and survival benefit.

With all these, the investigators hypothesize that treatment of locally advanced esophageal squamous cell carcinoma (ESCC)with cetuximab in combination with paclitaxel, cisplatin and radiation may further improve clinical outcomes. This trial results will be important as it may support further studies for setting the new treatment standard for ESCC.

Arms: arm 1: Cetuximab, injection, loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m\^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m\^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
Interventions: intervention 1: cetuximab (Erbitux) intervention 2: Paclitaxel intervention 3: Cisplatin intervention 4: Radiation
Intervention descriptions: intervention 1: Cetuximab,injection,loading dose400 mg/m\^2,(Day1 in Week1) followed by 250 mg/m\^2(Day1, every week for Weeks 2-8) intervention 2: Paclitaxel,injection,loading dose 45 mg/m\^2,(Day1 in every week for Weeks 2-8) intervention 3: Cisplatin,injection,loading dose 20 mg/m\^2,(Day1 in every week for Weeks 2-8) intervention 4: Radiation, External beam therapy, total 59.4 Gy , 33 fractions, 1.8 Gy per fraction.(Day 1-Day 5 in every week 2-week 8).

Protocol documents:
Clinical trial NCT00825916
Conditions: Scar Prevention Scar Reduction
Keywords: AZX100 Patient and Observer Scar Assessment Scale POSAS Visual Analog Scale VAS Keloid Scarring Scar reduction Scar prevention
Sponsor: Capstone Therapeutics
Start date: 2009-03-01; Completion date: 2010-07-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AZX100 Drug Product intervention 2: AZX100 Drug Product intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects were administered AZX100 3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery. intervention 2: Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery. intervention 3: Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.

Protocol documents:
Clinical trial NCT00827073
Conditions: Cataracts
Sponsor: Hermann Eye Center
Start date: 2008-11-01; Completion date: 2010-07-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if there is a difference on the penetration of betadine 5% when using lidocaine 2% jelly versus topical tetracaine 0.5% in topical cataract surgery. This will be assessed comparing bacterial colony count and species by taking swabs from the eye surface before and after the topical anesthesia has been administered.

Detailed description:
The purpose of this research study is to show that using Lidocaine2% jelly before surgery as an anesthetic (keep you from feeling touch or pain) for cataract surgery does not block the antiseptic (cleans and kills germs) effect of Betadine5%.

Arms: arm 1: Tetracaine 0.5% drop of betadine will be used on the operative eye after Tetracaine has been administered arm 2: Lidocaine 2% Jelly drop of betadine will be used on the operative eye after Lidocaine 2% Jelly has been administered
Interventions: intervention 1: tetracaine 0.5% intervention 2: Lidocaine 2% Jelly
Intervention descriptions: intervention 1: betadine 5% intervention 2: Betadine 5%

Protocol documents:
Clinical trial NCT00827372
Conditions: Lymphedema
Sponsor: Kathy Miller
Start date: 2009-01-01; Completion date: 2010-07-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The major purpose of this study is to determine if a new drug called pazopanib decreases lymphedema in subjects previously treated for cancer. Lymphedema, or swelling of the arm, is a result of damage to the lymphatic vessels in the arm during surgery and/or radiation. The damaged vessels can not adequately drain fluid from the arm, resulting in increased pressure and swelling. Pazopanib has not previously been studied as a treatment for lymphedema.

Detailed description:
Pazopanib inhibits the growth of blood vessels in tumors by inhibiting a protein called vascular endothelial growth factor (commonly called VEGF). Pazopanib is not currently approved by the US Food and Drug Administration (FDA) and therefore considered an experimental medication.

High levels of VEGF cause blood vessels to leak fluid, increasing the pressure in tumors similar to the increased pressure in lymphedema. Previous studies have found that treatment with pazopanib decreases the fluid pressure in tumors. That is why we think pazopanib might be an effective treatment for lymphedema.

Arms: arm 1: Pazopanib 800 mg orally once each day (maximum total duration of treatment = 24 weeks)
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: Pazopanib will be administered at a starting dose of 800 mg orally once each day.

Protocol documents:
Clinical trial NCT00831233
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2009-04-01; Completion date: 2010-07-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial was to see how well a new trial drug (degarelix) worked on lower urinary tract symptoms (also known as LUTS) in prostate cancer patients as compared to how a standard drug hormonal treatment worked on the same symptoms. The advancement/worsening of prostate cancer may be associated with LUTS and the symptoms may impact the ability to urinate normally and thereby the quality of life for these patients.

Patients were randomly selected (like flipping a coin) to receive either degarelix or standard hormone therapy (combination of goserelin and bicalutamide) for a 3 month treatment period. During this period the relief of urinary symptoms was evaluated via a questionnaire filled in by patients and addressing the severity and frequency of their symptoms.

Detailed description:

Arms: arm 1: Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL) arm 2: Goserelin (3.6 mg) + bicalutamide (50 mg)
Interventions: intervention 1: Degarelix intervention 2: Goserelin intervention 3: Bicalutamide
Intervention descriptions: intervention 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. intervention 2: Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The second and third doses of goserelin were administered on Days 31 and 59, respectively. intervention 3: On Day 0, three days before the first dose of goserelin on Day 3, patients began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin.

Protocol documents:
Clinical trial NCT00833703
Conditions: Heart Defects, Congenital
Keywords: cyanotic congenital heart disease shunt palliation thrombosis clopidogrel
Sponsor: Sanofi
Start date: 2009-01-01; Completion date: 2010-07-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is the extension of the CLARINET study \[NCT00396877 -EFC5314\] in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt.

The primary objective was to assess the safety up to 18 months of age of the extended use of Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of age.

The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis requiring intervention or any death.

Detailed description:
Patients remained in the treatment group to which they were originally allocated for the CLARINET study and continued blindly their treatment (0.2 mg/kg/day of clopidogrel or placebo) up to the occurrence of shunt thrombosis, next surgical procedure for correction of the congenital heart disease, death, or 18 months of age, whichever came first. The maximum treatment duration were 6 months.

Arms: arm 1: 0.2 mL/kg/day matching placebo solution once daily. arm 2: 0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily.
Interventions: intervention 1: Clopidogrel intervention 2: placebo
Intervention descriptions: intervention 1: Form: reconstituted solution using Clopidogrel powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight intervention 2: Form: reconstituted solution using matching placebo powder

Route: oral or enteric

Frequency: once daily

Dose: daily dose adjusted for weight

Protocol documents:
Clinical trial NCT00848250
Conditions: Congenital Heart Disease
Keywords: Cardiopulmonary Bypass ACE inhibitor Pediatrics
Sponsor: Vanderbilt University Medical Center
Start date: 2008-09-01; Completion date: 2010-07-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.

Detailed description:

Arms: arm 1: Patients already on an ACE inhibitor will continue it until the day of surgery arm 2: Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
Interventions: intervention 1: Angiotensin Converting Enzyme Inhibitor intervention 2: No ACE Inhibitor
Intervention descriptions: intervention 1: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery intervention 2: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery

Protocol documents:
Clinical trial NCT00855582
Conditions: Erectile Dysfunction Benign Prostatic Hyperplasia
Keywords: Erectile Dysfunction Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Start date: 2009-03-01; Completion date: 2010-07-01
Enrollment: 606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Tadalafil intervention 2: Placebo
Intervention descriptions: intervention 1: tablet once daily by mouth for 12 weeks. intervention 2: Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks.

Protocol documents:
Clinical trial NCT00857259
Conditions: Choroidal Neo-Vascular Age-onset Macular Degeneration Age-related Macular Degeneration
Keywords: AMD macular degeneration Everolimus Lucentis Ranibizumab Choroidal Neo-Vascular (CNV) age-onset macular degeneration Age-related Macular Degeneration (AMD)
Sponsor: Novartis Pharmaceuticals
Start date: 2009-02-01; Completion date: 2010-07-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD)

Detailed description:

Arms: arm 1: 5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28 arm 2: Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline) arm 3: Everolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
Interventions: intervention 1: Everolimus intervention 2: Ranibizumab
Intervention descriptions: intervention 1: 5 mg oral tablet intervention 2: 0.5 mg administered by intravitreal injection

Protocol documents:
Clinical trial NCT00871234
Conditions: Endothelial Function Lipids Insulin Resistance Inflammation HIV Infections
Keywords: HIV Endothelial function Etravirine
Sponsor: Indiana University
Start date: 2009-04-01; Completion date: 2010-07-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and effects of etravirine, an HIV antiretroviral medication, on vascular function.

Detailed description:
We hypothesize that in HIV-uninfected subjects, etravirine 200mg twice daily for four weeks will have no effect on endothelial function. The primary objective of this study is to determine the effects of etravirine 200mg twice daily given for four weeks on endothelial function, measured as flow-mediated dilation (FMD) of the brachial artery, in HIV-uninfected subjects. Secondary objectives include determination of the effects of etravirine 200mg twice daily given for four weeks on safety measures, lipid fractions, HOMA-IR, blood pressure, inflammatory parameters, and endothelial activation parameters.

Interventions: intervention 1: Etravirine
Intervention descriptions: intervention 1: Two one-hundred mg tablets orally twice daily for four weeks

Protocol documents: