ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00697073
Conditions: Friedreich's Ataxia
Keywords: Friedreich's Ataxia Idebenone ICARS
Sponsor: Santhera Pharmaceuticals
Start date: 2008-07-01; Completion date: 2010-05-01
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.

Detailed description:
The study involves 6 clinic visits.

Arms: arm 1: high dose Idebenone
Interventions: intervention 1: Idebenone
Intervention descriptions: intervention 1: Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day; Patients \> 45 kg/99 lbs: idebenone 2250 mg/day

Protocol documents:
Clinical trial NCT00698516
Conditions: Recurrent Small-cell Lung Cancer (SCLC) Lung Cancer, Small Cell
Keywords: Bevacizumab Small Cell Lung Cancer (SCLC) Topotecan
Sponsor: GlaxoSmithKline
Start date: 2008-07-01; Completion date: 2010-05-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Combination of Hycamtin (topotecan) and Avastin (bevacizumab) could allow killing of both endothelial and neoplastic cells. We postulate that addition of bevacizumab to topotecan will increase delivery of topotecan to tumor cells and may enhance activity of topotecan in patients with previously treated small cell lung cancer and improve progression free survival.

Detailed description:

Arms: arm 1: Oral topotecan + IV Bevacizumab
Interventions: intervention 1: Oral Hycamtin (topotecan) Capsules + IV Avastin (bevacizumab)
Intervention descriptions: intervention 1: 2.3 mg/m2 daily x 5 oral topotecan and 15 mg/kg IV bevacizumab on day 1 of every 21 days cycle.

Protocol documents:
Clinical trial NCT00705159
Conditions: Conjunctivitis
Keywords: Blepharokeratoconjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-06-01; Completion date: 2010-05-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.

Detailed description:

Arms: arm 1: Drug: Zylet (loteprednol etabonate and tobramycin) arm 2: Drug: Lotemax (loteprednol etabonate) arm 3: Drug: Tobramycin arm 4: Vehicle of Zylet
Interventions: intervention 1: loteprednol etabonate and tobramycin intervention 2: loteprednol etabonate intervention 3: Tobramycin intervention 4: Vehicle of Zylet
Intervention descriptions: intervention 1: Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days. intervention 2: Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days. intervention 3: Topical ocular administration of Tobramycin QID for 14 days. intervention 4: Topical ocular administration of the vehicle of Zylet QID for 14 days.

Protocol documents:
Clinical trial NCT00706797
Conditions: Rheumatoid Arthritis
Keywords: Moderate Rheumatoid Arthritis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2008-09-01; Completion date: 2010-05-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess comparative radiographic efficacy, clinical efficacy and safety of etanercept (ETN) + methotrexate (MTX) with usual disease-modifying anti-rheumatic drug (DMARD) treatment in subjects with moderate RA who were treated with MTX monotherapy, but continue to have moderate disease activity.

Detailed description:

Arms: arm 1: Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold). arm 2: Etanercept (ETN) 50 milligrams (mg) sub-cutaneous (SC) injection once weekly (pre-filled syringe) plus continuation of current dose of Methotrexate (MTX) either oral (PO), SC, or intramuscular (IM).
Interventions: intervention 1: etanercept (EnbrelTM) intervention 2: methotrexate
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00706849
Conditions: Heterozygous Familial Hypercholesterolemia Coronary Artery Disease
Keywords: familial hypercholesterolemia
Sponsor: Kastle Therapeutics, LLC
Start date: 2008-07-01; Completion date: 2010-05-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable dose of other lipid-lowering agents (including maximally tolerated statin therapy).

Detailed description:
Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder of lipoprotein metabolism characterized by markedly elevated LDL-C, premature onset of atherosclerosis and development of xanthomata. Patients with heterozygous familial hypercholesterolemia typically have total plasma cholesterol between 350 to 550 mg/dL and disease onset in their third and fourth decade.

Mipomersen (ISIS 301012) is an antisense drug that reduces a protein in the liver cells called apolipoprotein B (apo-B). Apo-B plays a role in producing low density lipoprotein cholesterol (the "bad" cholesterol) and moving it from the liver to one's bloodstream. High LDL-C is an independent risk factor for the development of coronary heart disease (CHD) or other diseases of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events.

This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period (with the exception of patients who enrolled in the open-label extension study \[Study 301012-CS6; NCT00694109\]). The treatment period spanned the time during which the study treatment was administered until the later of the primary efficacy time point (PET) or 14 days beyond the last day of study drug administration. The post-treatment follow-up period began the day after completion of the treatment period and ended on the day of the patient's last contact date within the study.

Following treatment and Week 28 evaluations, eligible patients who tolerated study drug could elect to enroll in an open-label extension study (301012-CS6). Patients who were not eligible for or who elected not to enroll in the open-label extension study and patients who discontinued during the 26-week treatment period were followed in this study for an additional 24 weeks from administration of the last dose of study drug.

Arms: arm 1: Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks. arm 2: Participants received a placebo subcutaneous injection once a week for 26 weeks.
Interventions: intervention 1: mipomersen sodium intervention 2: placebo
Intervention descriptions: intervention 1: 200 mg /mL intervention 2: 1 mL matching placebo

Protocol documents:
Clinical trial NCT00726882
Conditions: HCV Infection
Keywords: HCV Infection
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2008-08-01; Completion date: 2010-05-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with ABT-333 (dasabuvir).

Detailed description:
This Phase 2, multicenter study was conducted in HCV-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333. Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in Study M10-351 Substudy 2 (NCT00696904; ABT-333 dosing duration was 2 days) and Study M10-380 (NCT00851890; ABT-333 dosing duration was 28 days) were eligible.

After receiving at least 1 dose of ABT-333 or placebo, subjects were assessed for participation in this rollover study and asked to review the informed consent. The day of study completion or early discontinuation from the prior ABT-333 clinical study served as the baseline assessment. If it was found that a participant received placebo during the previous ABT-333 clinical study, the sites were instructed to discontinue the participant from this study.

This study included approximately monthly blood sample collection procedures for 48 weeks, and no treatment was provided during this time.

Arms: arm 1: Hepatitis C virus (HCV)-infected participants who received ABT-333 at any dose level or matching placebo in a prior clinical study involving ABT-333.

Participants received no treatment in this follow-up study.
Interventions: intervention 1: Blood sample collection only intervention 2: ABT-333
Intervention descriptions: intervention 1: Approximately monthly collection of blood samples. intervention 2: Previous treatment in prior ABT-333 studies.

Protocol documents:
Clinical trial NCT00728936
Conditions: Hepatitis C
Keywords: Hepatitis C unresponsive to pegylated interferon and ribavirin therapy hepatitis C virus
Sponsor: Idera Pharmaceuticals, Inc.
Start date: 2007-09-01; Completion date: 2010-05-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

Detailed description:
First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.

Arms: arm 1: IMO-2125 given weekly at 0.04 mg/kg arm 2: IMO-2125 given weekly at 0.08 mg/kg arm 3: IMO-2125 given weekly at 0.16 mg/kg arm 4: IMO-2125 given weekly at 0.32 mg/kg arm 5: IMO-2125 given weekly at 0.48 mg/kg arm 6: Weekly saline placebo arm 7: IMO-2125 given twice a week at 0.16 mg/kg
Interventions: intervention 1: IMO-2125 intervention 2: Saline placebo
Intervention descriptions: intervention 1: IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system intervention 2: saline placebo given subcutaneously

Protocol documents:
Clinical trial NCT00734630
Conditions: Hypertension
Keywords: nebivolol Bystolic ™ lisinopril losartan Hypertension
Sponsor: Forest Laboratories
Start date: 2008-08-01; Completion date: 2010-05-01
Enrollment: 491 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Detailed description:

Arms: arm 1: Nebivolol 5 mg, 5 mg nontrade tablets, oral administration Nebivolol 10 mg, 10 mg nontrade tablets, oral administration Nebivolol 20 mg, 20 mg nontrade tablets, oral administration Nebivolol 40 mg (two 20 mg nontrade tablets), oral administration arm 2: Matching placebo tablets, oral administration
Interventions: intervention 1: nebivolol intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily

Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration intervention 2: Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Protocol documents:
Clinical trial NCT00734968
Conditions: Stress Incontinence
Keywords: Urinary tract infection (UTI) suburethral sling Prevention Nitrofurantoin Prophylaxis
Sponsor: University of Missouri-Columbia
Start date: 2008-05-01; Completion date: 2010-05-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This project will determine whether post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

Detailed description:
This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

Arms: arm 1: Patients randomly assigned to be treated with nitrofurantoin 100mg PO BID x 3 days post-operatively arm 2: Arm randomly assigned to receive placebo 1 tablet PO BID x 3 days post-operatively.The incidence of UTI in this group will be compared with group one (1)
Interventions: intervention 1: Nitrofurantoin intervention 2: Placebo
Intervention descriptions: intervention 1: Nitrofurantoin 100mg PO BID for 3 days post operatively following the placement of a sub-urethral sling for the treatment of stress urinary incontinence intervention 2: 6 tablets to be taken 1 tablet PO BID. These tablets are identical to nitrofurantoin 100mg tablets.

Protocol documents:
Clinical trial NCT00743197
Conditions: Chest Pain
Keywords: coronary artery disease (CAD) chest pain myocardial ischemia endothelial function
Sponsor: Northwestern University
Start date: 2008-05-01; Completion date: 2010-05-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary arteries.

Coronary endothelial dysfunction (CED) is a condition in which the layers of cells around the heart do not function properly and is believed to be key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for future cardiovascular events, such as heart attack and stroke.

A coronary angiogram allows physicians to see if any of the arteries in the heart are blocked, usually by fatty plaque. In many instances, angiograms in women experiencing chest pain do not show evidence of coronary disease (free of significant plaque build-up). Currently, there is no standard of care treatment plan for patients with normal coronary arteries, despite symptoms of chest pain, and as a result these patients may not receive medical treatment. However, these women often return to their physicians more than once with chest pain and go through a similar battery of tests.

Detailed description:
Endothelial function testing will be performed on women without significant coronary disease in order to help identify women who may be likely to develop coronary artery disease (CAD) and who would benefit from aggressive lifestyle (dietary counseling, exercise) or medical (treatment with aspirin and cholesterol and blood pressure lowering medications) interventions.

Arms: arm 1: USUAL CARE GROUP-therapy in this group will be no dictated medical therapy, but usual care, as dictated by their referring physician. arm 2: TREATMENT GROUP-therapy in this group will be conventional treatment for CAD but targeting endothelial function, which will include aspirin, ACE-inhibitor and statin therapy, and therapeutic lifestyle changes.
Interventions: intervention 1: Aspirin intervention 2: Lisinopril intervention 3: Simvastatin intervention 4: Lovaza intervention 5: Therapeutic Lifestyle Changes
Intervention descriptions: intervention 1: Aspirin 81 mg daily intervention 2: Lisinopril 10 mg every night intervention 3: Simvastatin 20 mg every night intervention 4: Lovaza 1 gram daily intervention 5: Therapeutic lifestyle changes will be initiated with the assistance of a dietician, including diet counseling, exercise recommendation, and weight maintenance/weight loss.

Protocol documents:
Clinical trial NCT00759577
Conditions: Overactive Bladder
Sponsor: NYU Langone Health
Start date: 2008-09-01; Completion date: 2010-05-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label single center trial to study improvements in symptom bother and quality of life in overactive bladder patients self titrating solifenacin 5mg and 10 mg. The study is designed to reflect real world conditions in typical male and female OAB patients presenting for treatment.

Detailed description:
Open-label single center trial to study improvements in symptom bother and quality of life in OAB patients self titrating solifenacin 5mg and 10 mg. The study was designed to reflect real world conditions in typical male and female OAB patients presenting for treatment. After eligibility was confirmed, subjects completed a number of questionnaires which include patient perception of bladder condition (PPBC)12, Overactive Bladder Questionaire (OAB-q13), visual analog scale (VAS) 0-100 assessing bother of urge incontinence, urgency, frequency and nocturia over the past week.

Arms: arm 1: Patients were given drug to self titrate
Interventions: intervention 1: Solifenacin
Intervention descriptions: intervention 1: 5mg and 10 mg, oral once daily

Protocol documents:
Clinical trial NCT00770510
Conditions: Primary Insomnia
Keywords: Primary insomnia
Sponsor: Eisai Co., Ltd.
Start date: 2008-09-01; Completion date: 2010-05-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. Participants were randomly assigned to one of 10 prespecified treatment sequence patterns.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Eszopiclone 1 mg intervention 2: Eszopiclone 2 mg intervention 3: Eszopiclone 3 mg intervention 4: Placebo intervention 5: Zolpidem Tartrate 10 mg
Intervention descriptions: intervention 1: Eszopiclone 1 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days. intervention 2: Eszopiclone 2 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days. intervention 3: Eszopiclone 3 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days. intervention 4: Placebo tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days. intervention 5: Zolpidem Tartrate 10 mg tablet, taken orally at bed time for 2 consecutive nights. Each participant was assigned to one of 10 prespecified treatment sequence patterns. Each interval (five total intervals) of 2 consecutive nights was separated by a washout of approximately 5 days. A follow-up period consisted of 6 days.

Protocol documents:
Clinical trial NCT00770692
Conditions: Insomnia
Keywords: insomnia primary insomnia insomnia associated with psychiatric or physical disorder(s)
Sponsor: Eisai Co., Ltd.
Start date: 2008-10-01; Completion date: 2010-05-01
Enrollment: 369 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.

Detailed description:
This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly patients with insomnia.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Eszopiclone 1 mg- Elderly intervention 2: Eszopiclone 2 mg- Elderly intervention 3: Eszopiclone 3 mg- Non-elderly intervention 4: Eszopiclone 2 mg- Non-elderly
Intervention descriptions: intervention 1: Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.

Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment. intervention 2: Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.

Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment. intervention 3: Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.

Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment. intervention 4: Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.

Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.

Protocol documents: