ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01027897
Conditions: Sepsis
Keywords: Pharmacokinetics Pharmacodynamics Doripenem Trauma sepsis Trauma patients with sepsis
Sponsor: Emory University
Start date: 2010-04-01; Completion date: 2011-12-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study hypothesis is to measure how the drug doripenem is cleared from the body of critically ill trauma patients. The investigators will measure blood drug concentrations and calculate how much the drug distributes in the body and how fast it is removed from the body. There is little information on how drugs are cleared in critically ill patients and the wrong dose of a drug could make it ineffective. The investigators will use this information to predict the most reasonable dose to treat infections effectively in these patients.

Detailed description:
Understanding the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of an antibiotic can provide insight into developing appropriate dosing regimens. It is even more imperative at the present time to maximize PK/PD parameters since there are no new novel antimicrobial agents to treat resistant gram-negative infections. This approach allows us to achieve superior PD parameters and treat bacteria that would have been resistant to standard dosing due to higher minimum inhibitory concentrations (MICs).

Doripenem exhibits time-dependent bactericidal activity and the pharmacodynamic parameter predicting clinical and bacteriologic outcomes is the percentage of the dosing interval that free drug concentrations remain above the minimum inhibitory concentration (T \> MIC) of the infecting pathogen Sepsis is known to influence drug pharmacokinetics and pharmacodynamics as a result of changes in hemodynamics, capillary permeability, third spacing, acid-base status, serum proteins, and organ function. Moreover, trauma patients tend to be younger with fewer comorbidities. They are hypermetabolic and are often given aggressive fluid resuscitation resulting in increased renal clearance of drugs and a larger volume of distribution. As a consequence of these differences in PK parameters, the calculated PD parameters will likely differ resulting in sub-optimal T\> MIC. For time-dependent antibacterial agents such as doripenem, the T \> MIC is one of the most important pharmacodynamic parameters in predicting clinical efficacy, therefore it is imperative to evaluate the PK parameters in this particular population.

Arms: arm 1: Patients will receive doripenem for the treatment of their infection
Interventions: intervention 1: Doripenem
Intervention descriptions: intervention 1: Doripenem 1 gm administered over 4 hours X 3 doses

Protocol documents:
Clinical trial NCT01039519
Conditions: Gastrointestinal Stromal Tumor
Keywords: G.I. Stromal Tumor GIST
Sponsor: Synta Pharmaceuticals Corp.
Start date: 2010-01-01; Completion date: 2011-12-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if STA-9090 is effective in the treatment of patients with metastatic and/or unresectable GIST.

Detailed description:
Planned:

* Stage 1: 23 patients. If ≥4 patients had clinical benefit, an additional 32 patients were to be enrolled. Up to 3 additional patients with platelet-derived growth factor receptor, alpha polypeptide (PDGFRA) mutation were to be enrolled, regardless of the total study enrollment.
* Stage 2: 55 patients. Progressing to this stage was dependent on Stage 1 results.

Analyzed:

* Stage 1: 27 patients were enrolled and analyzed. The study was not expanded to Stage 2 due to insufficient efficacy.

Arms: arm 1: Ganetespib (STA-9090) 200 mg/m\^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
Interventions: intervention 1: Ganetespib
Intervention descriptions: intervention 1: Ganetespib 200 mg/m\^2 during an approximately 1-hour infusion once weekly for three consecutive weeks followed by a treatment-free week. Participants who demonstrate acceptable tolerability and objective clinical benefit (defined by at least stable disease or objective response per RECIST) can continue to receive ganetespib until disease progression or appearance of unacceptable toxicity.

Protocol documents:
Clinical trial NCT01040780
Conditions: Non-small Cell Lung Cancer
Keywords: Efficacy Safety EGFR-TKI phase III NSCLC
Sponsor: Betta Pharmaceuticals Co., Ltd.
Start date: 2009-02-01; Completion date: 2011-12-01
Enrollment: 399 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Icotinib is at least non-inferior to Gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients after one or two chemotherapies.

Detailed description:
Lung cancer is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years . It is the leading cause of death of cancer in man and 2nd in women. With the development of gefitinib and erlotinib, EGFR-TKI (epidermal growth factor receptor -tyrosine kinase inhibitor) is the most successful novel drugs developed for the treatment of these patients in recent years, especially for NSCLC patients in Asia including China. Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. It appears to be at least as good as gefitinib in terms of efficacy and better in terms of safety in phase I/II trials. In this study, a randomized, double-blind, gefitinib as control, multi-center phase III trial was designed to evaluate the safety and efficacy of icotinib in the treatment of advanced NSCLC patients after failure of 1 or 2 chemotherapy. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point. A total of 400 patients will be recruited. EGFR and K-ras gene mutational analysis as well as a population PK study have also been proposed.

Arms: arm 1: 125 mg three times daily (375 mg per day) by mouth arm 2: 250 mg every 24 hours by mouth
Interventions: intervention 1: Icotinib intervention 2: Gefitinib
Intervention descriptions: intervention 1: 125 mg three times daily (375 mg per day) by mouth intervention 2: 250 mg every 24 hours by mouth

Protocol documents:
Clinical trial NCT01047475
Conditions: Colorectal Cancer
Keywords: MB-6 FOLFOX4 Metastatic Colorectal Cancer
Sponsor: Microbio Co Ltd
Start date: 2009-10-01; Completion date: 2011-12-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in addition to standard chemotherapy in the treatment of patients with metastatic colorectal cancer.

Detailed description:

Arms: arm 1: MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks arm 2: Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks
Interventions: intervention 1: MB-6 intervention 2: Placebo
Intervention descriptions: intervention 1: 6# TID with meal intervention 2: 6# TID with meal

Protocol documents:
Clinical trial NCT01051921
Conditions: Hepatitis C
Keywords: HCV Null Responder
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2010-01-01; Completion date: 2011-12-01
Enrollment: 67 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the combination treatment of CTS-1027, pegylated interferon and ribavirin can improve the response rates in HCV patients who did not previously respond to pegylated interferon and ribavirin therapy.

Detailed description:
A subset of non-responders to standard of care treatments (pegylated interferon and ribavrin) is termed null responders. Null responders are the most treatment refractory population. Treatment for null responders is currently limited: retreatment with SOC results in approximately 5% sustained virologic response (SVR).

CTS-1027 may facilitate the activity of interferon by preventing MMP-induced cleavage and deactivation in both phases of clinical response to therapy. In addition, CTS-1027, like ribavirin, alone does not significantly affect viral replication, but both CTS-1027 and ribavirin are likely to impact response to therapy during the second and slower phase of the clinical response.

The potential of MMP inhibition to facilitate the action of interferon, together with ribavirin-driven up-regulation of interferon stimulated genes, has the potential to yield a potent host immune response in this highly resistant null-responder patient population. Again, since MMP inhibition is thought to target the second slower phase kinetics, the initial treatment duration in this trial will be 24 weeks.

This trial will evaluate the safety and efficacy of CTS-1027 combined with SOC in patients who did not previously respond to SOC therapy.

Arms: arm 1: Study drug (CTS-1027) plus Standard of Care treatment (pegylated interferon and ribavirin).

CTS-1027, 15 mg taken twice daily. Pegylated interferon, 180 μg injected once a week. Ribavirin, 1000 mg or 1200 mg daily (depending on patient weight), taken in two divided doses.
Interventions: intervention 1: CTS-1027 intervention 2: Pegylated interferon intervention 3: Ribavirin
Intervention descriptions: intervention 1: CTS-1027 supplied in 5 and 10 mg tablets, 15 mg taken twice daily, for up to 48 weeks intervention 2: Pegylated interferon, 180 micrograms in 0.5 ml of solution injected subcutaneously (SQ) once per week, for up to 48 weeks. Packaged in single use syringes. intervention 3: Ribavirin, 200 mg capsules taken in two divided daily doses totaling 1000 mg (5 capsules) for patients weighing 75 kg or less, or 1200 mg (6 capsules) for patients weighing more than 75 kg for up to 48 weeks.

Protocol documents:
Clinical trial NCT01053156
Conditions: Fragile X Syndrome
Keywords: Fragile X syndrome minocycline targeted treatment
Sponsor: University of California, Davis
Start date: 2010-01-01; Completion date: 2011-12-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. We are investigating its use in FXS because it lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also strengthens brain connections in the animal models of FXS. We hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile X patients.

Detailed description:
This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. We are investigating its use in FXS because it lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also strengthens brain connections in the animal models of FXS. We hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile X patients.

The aim of this study is to carry out a double-blind placebo controlled trial of minocycline treatment in children with FXS who are 3.5 to 16 years of age. At baseline, we will assess behavior and perceptual and cognitive development. After the children have been treated for 3 months with either minocycline or placebo, they undergo the same baseline testing. They will then cross over and be treated for a second 3 months. We will carry out testing again at the end of the second 3 month period. We will also assess the side effects of minocycline treatment throughout the study.

Arms: arm 1: All patients will be on placebo for 3 months in this crossover study. arm 2: All patients will be on minocycline for 3 months in this crossover trial.
Interventions: intervention 1: minocycline hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Minocycline hydrochloride dosed orally once a day for 3 months. intervention 2: Placebo will be given daily for 3 months.

Protocol documents:
Clinical trial NCT01058668
Conditions: Mania Bipolar I Disorder
Keywords: Acute Mania Bipolar I Disorder
Sponsor: Forest Laboratories
Start date: 2010-02-01; Completion date: 2011-12-01
Enrollment: 497 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Detailed description:

Arms: arm 1: Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks. arm 2: Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks. arm 3: Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Interventions: intervention 1: Cariprazine intervention 2: Placebo
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. intervention 2: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.

Protocol documents:
Clinical trial NCT01063829
Conditions: HCMV Reactivation or HCMV End-Organ Disease
Keywords: HCMV
Sponsor: AiCuris Anti-infective Cures AG
Start date: 2010-03-01; Completion date: 2011-12-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).

Detailed description:

Arms: arm 1: 60 mg AIC246, one tablet per day arm 2: 120 mg AIC246, one tablet per day arm 3: 240 mg AIC246, one tablet per day arm 4: Placebo arm
Interventions: intervention 1: 60 mg AIC246 intervention 2: 120 mg AIC246 intervention 3: 240 mg AIC246 intervention 4: Placebo
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration intervention 3: Oral administration intervention 4: Oral administration

Protocol documents:
Clinical trial NCT01067326
Conditions: Endothelial Dysfunction
Keywords: Endothelial Dysfunction Endothelial Function Tekturna Endothelial Peripheral Arterial Tomography (EndoPAT) Progenitor Cells renin inhibition endothelial progenitor cells early atherosclerosis
Sponsor: Mayo Clinic
Start date: 2010-02-01; Completion date: 2011-12-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We will study the hypothesis that long-term Tekturna treatment will improve endothelial function and the production and function of endothelial progenitor cells (EPCs) in patients with early atherosclerosis. Specifically, long-term Tekturna treatment will increase the Reactive Hyperemia Peripheral Arterial Tonometry indexes and increase the numbers and the function of circulating endothelial progenitor cells, compared to placebo, in association with a reduction in inflammation and oxidative stress.

Detailed description:
Aliskiren is a direct renin-inhibitor and may have beneficial effects on the vascular endothelium, similar to other antihypertensive therapies targeting the renin-angiotensin-aldosterone system (RAAS). The current study was designed to test the hypothesis that aliskiren improves endothelial function and increases the number of endothelial progenitor cells (EPCs) in normotensive patients with early atherosclerosis.

Arms: arm 1: 150 mg Aliskiren once daily for a period of 4 months. arm 2: 1 pill per day by mouth for 4 months.
Interventions: intervention 1: Aliskiren intervention 2: Placebo
Intervention descriptions: intervention 1: 150 mg Aliskiren once daily for a period of 4 months intervention 2: 1 pill per day by mouth for 4 months

Protocol documents:
Clinical trial NCT01075217
Conditions: Peripheral Arterial Occlusive Disease
Keywords: Peripheral arterial occlusive disease (PAOD)
Sponsor: Bracco Diagnostics, Inc
Start date: 2010-04-01; Completion date: 2011-12-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
No significant differences is expected in observed motion artifacts, heat or pain reported during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: iopamidol intervention 2: iodixanol
Intervention descriptions: intervention 1: Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot). intervention 2: Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).

Protocol documents:
Clinical trial NCT01089023
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-01-01; Completion date: 2011-12-01
Enrollment: 95 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab \[RoActemra/Actemra\] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions

Protocol documents:
Clinical trial NCT01103414
Conditions: Type 2 Diabetes
Keywords: Diabetes
Sponsor: Metabolic Solutions Development Company
Start date: 2010-09-01; Completion date: 2011-12-01
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.

Detailed description:
The primary study objectives are to characterize the reduction in fasting plasma glucose in response to three different doses of Mitoglitazone as compared to placebo following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes and to investigate the safety and tolerability of three different doses of Mitoglitazone following once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.

Arms: arm 1: Mitoglitazone 50 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. arm 2: Mitoglitazone 100 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. arm 3: Mitoglitazone 150 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. arm 4: Pioglitazone 45 mg capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days. arm 5: Placebo capsules self administered once-daily each morning after an overnight fast and 30 minutes before the morning meal for 84 days.
Interventions: intervention 1: Mitoglitazone intervention 2: Mitoglitazone intervention 3: Mitoglitazone intervention 4: Pioglitazone intervention 5: Placebo
Intervention descriptions: intervention 1: 50 mg capsules, once daily for 84 days intervention 2: Mitoglitazone 100 mg capsules, once daily for 84 days intervention 3: Mitoglitazone 150 mg capsules, once daily for 84 days intervention 4: Pioglitazone 45 mg, once daily for 84 days intervention 5: Placebo, once daily for 84 days

Protocol documents:
Clinical trial NCT01105117
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension PAH EPITOME-1
Sponsor: Actelion
Start date: 2010-05-01; Completion date: 2011-12-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.

Detailed description:

Arms: arm 1: ACT-385781A (Actelion Epoprostenol) arm 2: Flolan®
Interventions: intervention 1: ACT-385781A (Actelion Epoprostenol) intervention 2: Flolan®
Intervention descriptions: intervention 1: per Prescribing Information intervention 2: per Prescribing Information

Protocol documents:
Clinical trial NCT01109381
Conditions: Helicobacter Pylori Infection
Keywords: bacterial infections anti-infective agents gastrointestinal agents antibacterial agents omeprazole lauric acid n-acetylcysteine helicobacter infections helicobacter pylori non-antibiotic treatment
Sponsor: Synergy Pharmaceuticals Pte. Ltd.
Start date: 2010-05-01; Completion date: 2011-12-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
At present, triple therapy is recommended by various guidelines for the treatment of Helicobacter pylori (H.pylori) infection. Recent studies have shown increasing resistance of H.pylori to commonly used antibiotics used in triple therapy. This study explores a non-antibiotic treatment regime for H.pylori that uses lauric acid as the primary anti-microbial agent. The study hypothesis is that Lauric acid works synergistically with omeprazole following administration of a mucolytic agent to kill H.pylori topically in the stomach.

Detailed description:

Arms: arm 1: Initial phase - omeprazole, N-acetyl cysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid
Interventions: intervention 1: GT08
Intervention descriptions: intervention 1: GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily

Protocol documents: