ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00906087
Conditions: Glaucoma
Keywords: Myocilin gene Glaucoma dorzolamide and timolol combination eyedrop
Sponsor: University of Michigan
Start date: 2009-08-04; Completion date: 2012-07-18
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if one of the genes that can cause glaucoma, called myocilin, are associated with larger eye pressure and blood pressure changes in sitting and lying down positions without glaucoma drug treatment and with glaucoma drug treatment with a combination medication called Cosopt® (Merck \& Co., Inc.).

Detailed description:
Glaucoma is an important public health issue, and identifying new markers to improve treatment outcomes is a high priority. Progress in Mendelian genetic approaches has led to identifying 15 genes and 31 loci (http://www.ncbi.nlm.nih.gov/); however, since these monogenic forms of glaucoma are uncommon, other approaches are needed to identify genetic markers that contribute to common risk factors, such as elevated eye pressure, eye pressure fluctuation, and drug response variation.

It is well known that eye pressure varies over a 24-hour period,1-6 but the mechanisms that regulate this eye pressure rhythm are not yet fully known. Drance reported that 84% of normal eyes (N=320 eyes) had eye pressure fluctuations of less than 5 mmHg in contrast to only 6% of untreated glaucomatous eyes (N=138).7 Drance clearly recognized that eye pressure factors were more variable in eyes with glaucoma. Attention to this eye pressure fluctuation during glaucoma treatment is important because fluctuation leads to progression. The variation in eye pressure drug response profiles measured at selected times over a 24-hour period is related to the mechanism of action of these drugs, endogenous circadian rhythms, and glaucoma. The molecular and genetic tools are now available to identify potential genetic markers for these variable traits.

Advancing clinical research to the "translational" level is an important step to integrate our ever increasing knowledge base in genomics and proteinomics with clinical trials and clinical studies. Given the infrastructure at the University of Michigan with the strength in both glaucoma genetics and our resources in the clinic, it is possible to test for relationships between glaucoma genes and eye pressure. Although it is known that myocilin (MYOC) mutations cause the phenotype of high pressure open-angle glaucoma, the effect of these MYOC mutations in "pre-symptomatic" subjects and patients with early open-angle glaucoma on eye pressure variation is not known.

Arms: arm 1: Intraocular pressure and blood pressure measurements will be compared under the following conditions: 1) after washout of clinical treatment, 2) after treatment with Cosopt, and 3) after another washout of Cosopt.
Interventions: intervention 1: Cosopt (combination eyedrop of dorzolamide and timolol)
Intervention descriptions: intervention 1: One drop in each eye every twelve hours for six weeks

Protocol documents:
Clinical trial NCT01106430
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Sponsor: Shire
Start date: 2010-06-28; Completion date: 2012-07-19
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lisdexamfetamine Dimesylate intervention 2: Atomoxetine Hydrochloride
Intervention descriptions: intervention 1: Oral 30, 50, or 70mg once-daily for 9 weeks intervention 2: Oral 10mg to 100mg once-daily for 9 weeks

Protocol documents:
Clinical trial NCT01577238
Conditions: Bacterial Vaginosis
Keywords: SPL7013 VivaGel bacterial vaginosis BV
Sponsor: Starpharma Pty Ltd
Start date: 2012-03-28; Completion date: 2012-07-20
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 1% SPL7013 Gel intervention 2: Placebo
Intervention descriptions: intervention 1: Vaginal gel, daily for 7 days intervention 2: Vaginal gel, daily for 7 days

Protocol documents:
Clinical trial NCT01316887
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease COPD nDPI long-acting beta agonist long-acting muscarinic antagonist tolerability safety
Sponsor: GlaxoSmithKline
Start date: 2011-01-01; Completion date: 2012-07-21
Enrollment: 563 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.

Detailed description:
Several studies have demonstrated the efficacy and safety of combining an individual LABA compound plus an individual LAMA compound in COPD. These studies have shown the combination of these two products to be superior to either agent alone on a variety of outcomes in COPD. The beneficial effects of this combination regimen are likely due to the different mechanisms of action of the two bronchodilators (smooth bronchial muscle relaxation from activation of beta2 receptors from the LABA product and inhibition of acetylcholine-mediated smooth bronchial muscle contraction via blockade of muscarinic receptors from the LAMA product). The availability of a LABA/LAMA combination in one product instead of two individual products is a technical and therapeutic advancement in the pharmacological armamentarium for COPD and may lead to increased patient compliance due to once-daily administration. The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication, and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control. All treatments will be delivered once-daily via the nDPI. This study will establish the long-term safety profile of GSK573719/GW642444 Inhalation Powder 125/25mcg once-daily in subjects with COPD. The safety profile of GSK573719 Inhalation Powder125mcg once-daily will also be evaluated.

Arms: arm 1: 125/25 mcg once-daily arm 2: 125 mcg once-daily arm 3: inactive
Interventions: intervention 1: 125/25 mcg once-daily GSK573719/GW642444 intervention 2: 125mcg once-daily GSK573719 intervention 3: Placebo once-daily
Intervention descriptions: intervention 1: GSK573719/GW642444 intervention 2: GSK573719 intervention 3: inactive

Protocol documents:
Clinical trial NCT01552928
Conditions: Healthy
Sponsor: Shire
Start date: 2012-03-29; Completion date: 2012-07-25
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated for their ability to prolong the QT interval which represents the duration of ventricular depolarization and subsequent repolarization. The primary objective of the study is to assess the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose of anagrelide when compared to placebo and a positive control.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Anagrelide 0.5 mg intervention 2: Anagrelide 2.5 mg intervention 3: Moxifloxacin intervention 4: Placebo
Intervention descriptions: intervention 1: 0.5mg Anagrelide single oral dose intervention 2: 2.5mg Anagrelide single oral dose intervention 3: 400 mg Moxifloxacin single oral dose intervention 4: Anagrelide placebo + Moxifloxacin placebo single oral dose

Protocol documents:
Clinical trial NCT00993616
Conditions: Brenner Tumor Fallopian Tube Cancer Ovarian Clear Cell Cystadenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mixed Epithelial Carcinoma Ovarian Mucinous Cystadenocarcinoma Ovarian Serous Cystadenocarcinoma Ovarian Undifferentiated Adenocarcinoma Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2009-12-01; Completion date: 2012-07-29
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving belinostat together with carboplatin works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to carboplatin or cisplatin. Belinostat 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. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with carboplatin may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the antitumor activity of belinostat and carboplatin in patients with persistent or recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, measured by objective response rate and the frequency of progression- free survival at 6 months.

II. To determine the nature and degree of toxicity of belinostat in combination with carboplatin in this cohort of patients.

OUTLINE: This is a multicenter study.

Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.
Interventions: intervention 1: belinostat intervention 2: carboplatin
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00633893
Conditions: Venous Thrombosis
Sponsor: Bristol-Myers Squibb
Start date: 2008-05-01; Completion date: 2012-08-01
Enrollment: 2711 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Detailed description:

Arms: arm 1: 2.5 mg arm 2: 5.0 mg arm 3: 0 mg
Interventions: intervention 1: Apixaban intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, twice daily, 12 months intervention 2: Tablets, Oral, twice daily, 12 months

Protocol documents:
Clinical trial NCT00828841
Conditions: Non-Small Cell Lung Cancer
Sponsor: Accelerated Community Oncology Research Network
Start date: 2008-12-01; Completion date: 2012-08-01
Enrollment: 601 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising and should be tested further. The study will also look at what side effects may occur.

Detailed description:

Arms: arm 1: Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. arm 2: Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. arm 3: Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Interventions: intervention 1: Cetuximab intervention 2: Paclitaxel intervention 3: Carboplatin intervention 4: Gemcitabine intervention 5: Cisplatin
Intervention descriptions: intervention 1: Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks. intervention 2: Paclitaxel 200 mg/m2 Day 1 every 21 days intervention 3: Carboplatin AUC 6 Day 1 every 21 days intervention 4: Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days intervention 5: Cisplatin 75 mg/m2 Day I every 21 days

Protocol documents:
Clinical trial NCT00891735
Conditions: Age-related Macular Degeneration
Keywords: Lucentis AMD Age-related macular degeneration Subfoveal neovascular age-related macular degeneration Wet AMD Macular degeneration Ranibizumab
Sponsor: Genentech, Inc.
Start date: 2009-07-01; Completion date: 2012-08-01
Enrollment: 1097 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Results are presented for the first 12 months of the study.

Detailed description:

Arms: arm 1: Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. arm 2: Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months. arm 3: Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally. arm 4: Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Sterile solution for intravitreal injection.

Protocol documents:
Clinical trial NCT00894387
Conditions: Acute Decompensated Heart Failure Congestive Heart Failure
Keywords: elevated BNP reduced LVEF Acute Heart Failure Cardiovascular death CHF hospitalization morbi-mortality trial outcome study endpoint driven plasma renin activity renin angiotensin aldosterone system direct renin inhibitors BNP KCCQ eGFR
Sponsor: Novartis Pharmaceuticals
Start date: 2009-05-01; Completion date: 2012-08-01
Enrollment: 1639 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

Detailed description:

Arms: arm 1: Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. arm 2: Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
Interventions: intervention 1: Aliskiren intervention 2: Placebo
Intervention descriptions: intervention 1: Aliskiren 150 mg and Aliskiren 300 mg intervention 2: Placebo

Protocol documents:
Clinical trial NCT01125189
Conditions: Hepatitis C Virus
Sponsor: Bristol-Myers Squibb
Start date: 2010-07-01; Completion date: 2012-08-01
Enrollment: 558 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Daclatasvir intervention 2: Daclatasvir intervention 3: Placebo intervention 4: peg-interferon alfa-2a intervention 5: ribavirin
Intervention descriptions: intervention 1: Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response intervention 2: Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response intervention 3: Tablets, oral, 0 mg, once daily, 24 weeks intervention 4: Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response intervention 5: Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response

Protocol documents:
Clinical trial NCT01181128
Conditions: Severe Hemophilia A
Sponsor: Bioverativ Therapeutics Inc.
Start date: 2010-11-01; Completion date: 2012-08-01
Enrollment: 165 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

Detailed description:
Participants are assigned to one of three treatment regimens: 1) a tailored prophylaxis regimen, 2) a weekly dosing regimen, or 3) an on-demand regimen. Treatment continued for 28 (±2) to 52 (±2) weeks. PK assessments for all participants are conducted on varying schedules, according to participants' group assignments. Additionally, two subgroups are defined. One subgroup of participants undergo PK profiling with a single dose of the comparator Advate®. A second subgroup consists of participants from any of the treatment arms that required surgery during the study. Depending upon country location, participants might have the option of continuing treatment within study 8HA01EXT (NCT01454739).

Arms: arm 1: On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A \>= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.

After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity. arm 2: 65 IU/kg of rFVIIIFc via IV injection every 7 days arm 3: 10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
Interventions: intervention 1: Factor VIII (rFVIIIFc) intervention 2: Advate®
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: