ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01586338
Conditions: Osteoarthritis
Sponsor: Sanofi
Start date: 2012-03-01; Completion date: 2013-09-01
Enrollment: 237 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

* To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score
* To evaluate the safety using the incidence, severity, seriousness, relatedness, and frequency of all treatment emergent Adverse Events (AEs)

Secondary Objectives:

* To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8, and 12
* To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26
* To evaluate the change in Patient Global Assessment (PTGA) score between baseline and weeks 8, 12 and 26
* To evaluate the change in Clinical Observer Global Assessment (COGA) score between baseline and weeks 8, 12 and 26
* To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and between baseline and weeks 1, 2, 8, 12 and 26

Detailed description:
Duration of study period for each participants was 26-28 weeks.

Arms: arm 1: Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
Interventions: intervention 1: Hylan G-F 20
Intervention descriptions: intervention 1: Intra-articular injection (pre-filled glass syringe)

Protocol documents:
Clinical trial NCT01588366
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2012-04-01; Completion date: 2013-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study will image the liver using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes mellitus, when they take LY2409021 to see if liver changes happen at the same time as changes in blood tests. This study is approximately 11 weeks long, not including screening. A screening appointment is required within 28 days prior to the start of the study.

Detailed description:

Arms: arm 1: Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days. arm 2: Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.) arm 3: Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days.
Interventions: intervention 1: Placebo intervention 2: LY2409021
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT01597050
Conditions: Lupus Erythematosus, Discoid Lupus Erythematosus, Systemic
Keywords: Discoid Lupus Erythematosus Systemic Lupus Erythematosus
Sponsor: Rigel Pharmaceuticals
Start date: 2012-08-01; Completion date: 2013-09-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety, efficacy and tolerability of topical R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) patients with active discoid lesions.

Detailed description:
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the preliminary efficacy, safety, tolerability, and pharmacokinetics of topical R333 ointment formulated at 6% (60 mg/g) in DLE and SLE patients with active discoid lesions.

Arms: arm 1: R333 6% (60 mg/g), bid arm 2: Placebo, bid
Interventions: intervention 1: R932333 intervention 2: Placebo
Intervention descriptions: intervention 1: R393233 6% (60 mg/g), bid intervention 2: Placebo, bid

Protocol documents:
Clinical trial NCT01599637
Conditions: Chronic Idiopathic Urticaria
Keywords: Chronic idiopathic urticaria CIU Xolair IGE025 FcεRI IgE
Sponsor: Novartis Pharmaceuticals
Start date: 2012-04-01; Completion date: 2013-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to explore the mode of action for omalizumab therapy in patients with chronic idiopathic urticaria.

Detailed description:

Arms: arm 1: Patients will receive omalizumab administered subcutaneously every 4 weeks at the study center. arm 2: Placebo administered subcutaneously every 4 weeks at the study center.
Interventions: intervention 1: IGE025 intervention 2: placebo
Intervention descriptions: intervention 1: Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial. intervention 2: Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.

Protocol documents:
Clinical trial NCT01607645
Conditions: Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Myeloid Leukemia Refractory Anemia With Excess Blasts
Sponsor: Fred Hutchinson Cancer Center
Start date: 2012-07-01; Completion date: 2013-09-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goals of this study are to learn about the effectiveness, the side-effects, if waiting to give the idarubicin and cytarabine may change the side effects or effectiveness, and to identify factors to predict for responses to this therapy. The trial will examine combination of three chemotherapy drugs. These drugs are decitabine, idarubicin, and cytarabine.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the morphologic complete remission (CR) rates using a decitabine (DAC)-priming followed by idarubicin (IDA) and cytarabine (ARAC) in patients with relapsed or refractory acute myeloid leukemia (AML).

SECONDARY OBJECTIVES:

I. To determine CR without minimal residual disease (CRMRD-), CR with incomplete blood count recovery (CRi), CR with minimal residual disease (CRMRD+), and CR with incomplete blood count recovery and with minimal residual disease (CRiMRD+) rates.

II. To estimate the frequency and severity of regimen-related toxicities.

III. To identify biomarkers (e.g., deoxyribonucleic acid \[DNA\] methylation and expression changes including interferon regulatory factor \[IRF\]8) associated with clinical responses.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive decitabine intravenously (IV) over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.

ARM II: Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.

In both arms, treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for 5 years.

Arms: arm 1: Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. arm 2: Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.
Interventions: intervention 1: decitabine intervention 2: idarubicin intervention 3: cytarabine
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV

Protocol documents:
Clinical trial NCT01636076
Conditions: COPD
Keywords: COPD
Sponsor: Novartis Pharmaceuticals
Start date: 2012-11-01; Completion date: 2013-09-01
Enrollment: 629 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD

Detailed description:

Arms: arm 1: QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device arm 2: Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
Interventions: intervention 1: QMF149 intervention 2: Salmeterol
Intervention descriptions: intervention 1: delivered via Concept1 device intervention 2: delivered via Accuhaler®

Protocol documents:
Clinical trial NCT01663532
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-10-01; Completion date: 2013-09-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia.

The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.

Detailed description:

Arms: arm 1: Aripiprazole IM Depot 400 mg, with allowed decrease to 300 mg for safety and return to 400 mg for efficacy if needed, every four weeks for 12 weeks arm 2: Matching placebo
Interventions: intervention 1: Aripiprazole IM Depot intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Matching Placebo

Protocol documents:
Clinical trial NCT01673178
Conditions: Diabetes Melliuts, Type 2
Keywords: Type 2 diabetes safety multiple dose intravenous
Sponsor: Pfizer
Start date: 2012-10-01; Completion date: 2013-09-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a trial in obese subjects who have poor lipid control with and without Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of PF-05231023

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: 25 mg PF-05231023 intervention 3: 50 mg PF-05231023 intervention 4: 100 mg PF-05231023 intervention 5: 150 mg PF-05231023
Intervention descriptions: intervention 1: 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks intervention 2: 25 mg IV once a week for 4 weeks intervention 3: 50 mg IV once a week for 4 weeks intervention 4: 100 mg IV once a week for 4 weeks intervention 5: 150 mg IV once a week for 4 weeks

Protocol documents:
Clinical trial NCT01686451
Conditions: Dyslipidemias
Sponsor: Wenzhou Medical University
Start date: 2012-08-01; Completion date: 2013-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Both XueZhiKang and Statins are cholesterol-lowering medications that are often prescribed for individuals with high cholesterol and who are at risk for cardiovascular disease (CVD). Several studies, including one randomized, double-blind, placebo-controlled clinical trial, have suggested that the use of statins is more frequently associated with fatigue. And XueZhiKang may be not. The purpose of this study is to compare the effect of these two medications on fatigue in persons who are at moderate to low CVD risk based on the risk estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis Society) guidelines (2011) for the management of dyslipidemias.

Detailed description:
Individuals at risk for cardiovascular disease (CVD) are often prescribed statins, which are medications that reduce the amount of cholesterol in the blood. By lowering cholesterol levels, these individuals have a lower incidence of coronary artery disease, ischemic stroke, and peripheral arterial disease and so on. While statins are effective at lowering cholesterol levels, their effect on fatigue is obvious and has been suggested by several studies, including one randomized, double-blind, placebo-controlled clinical trial. And XueZhiKang may be not. The purpose of this study is to compare the effect of these two medications on fatigue in persons who are at moderate to low CVD risk based on the risk estimation system in ESC(European Society of Cardiology)/ESA(European Atherosclerosis Society) guidelines (2011) for the management of dyslipidemias.

This study will enroll individuals who do not currently take cholesterol-lowering medications. Participants will be randomly assigned to receive 600mg of XueZhiKang twice a day, or 20mg of simvastatin daily for 4 weeks. Study visits will occur at baseline and Week 4. Blood will be collected for laboratory testing, and standardized psychological questionnaires will assess fatigue scores and physical activity levels at baseline and week 4. Pill count will be used to assess adherence of XueZhiKang and simvastatin treatment at week 4. At week 4, medication side effects will be monitored and tests of alanine aminotransferase (ALT), aspartate aminotransaminase (AST) and creatine phosphate kinase (CPK) will be performed. At week 4, medication efficacy will be assessed and test of low-density lipoprotein cholesterol (LDL-C) will be performed.

Arms: arm 1: Participants will receive 600mg of XueZhiKang twice a day for 4 weeks. arm 2: Participants will receive 20mg of simvastatin daily for 4 weeks.
Interventions: intervention 1: XueZhiKang intervention 2: simvastatin
Intervention descriptions: intervention 1: Participants will receive 600mg of XueZhiKang twice a day for 4 weeks. intervention 2: Participants will receive 20mg of simvastatin daily for 4 weeks.

Protocol documents:
Clinical trial NCT01694069
Conditions: Cystic Fibrosis
Keywords: piperacillin tazobactam pseudomonas aeruginosa cystic fibrosis pulmonary exacerbation continuous infusion beta lactam
Sponsor: West Virginia University
Start date: 2012-09-01; Completion date: 2013-09-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas aeruginosa.

Patients with cystic fibrosis require frequent therapy with intravenous (I.V.) antibiotics to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is thought to be the most effective when there is a constant level of drug in the body. The standard way to administer piperacillin-tazobactam is to give several grams 4 times each day as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more likely that drug will remain at a constant level in the body. The objective of this study is to determine if administering piperacillin-tazobactam as a continuous infusion is more effective at treating people having a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a day.

Detailed description:
All patients will receive combination therapy to include piperacillin-tazobactam 400 mg/kg/day (based on piperacillin component, actual body weight) not to exceed 16 grams and tobramycin 12 mg/kg/day extended interval dosing (once daily). Patients randomized to the continuous infusion group will receive a one-time loading dose of 100 mg/kg over 30 minutes followed immediately by initiation of the continuous infusion.

Other antibiotics with activity against Pseudomonas aeruginosa are not allowed. Patients may receive an antibiotic for treatment of Staphylococcus aureus if deemed appropriate.

Other treatments for pulmonary exacerbation of cystic fibrosis will be left up to the control of the treating physician. Patients will receive a total of 14 days of therapy. If deemed appropriate, patients may be discharged to home where they will continue to receive blinded treatment via an infusion pump. Patients will be evaluated after completing their 14 day course of antibiotics (end of therapy).

Arms: arm 1: Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams), divided in four equal doses, administered over 30 minutes, four times a day arm 2: Piperacillin-tazobactam administered at a dose of 400 mg/kg/day (maximum of 16 grams) as a continuous infusion over 24 hours, once daily
Interventions: intervention 1: Piperacillin-tazobactam combination product
Intervention descriptions: intervention 1: 400 mg/kg/day as either intermittent or continuous infusion

Protocol documents:
Clinical trial NCT01712204
Conditions: Gout Flares
Keywords: Prophylaxis of Acute Gout Flares Urate-Lowering Therapy Hyperuricemia Gouty arthritis
Sponsor: TWi Biotechnology, Inc.
Start date: 2013-01-01; Completion date: 2013-09-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis with good safety record and very few contraindications to the co-morbidities commonly among gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in clinical trials. The favorable product profile of AC-201 overall provides a strong rationale for investigating its clinical utility as prophylaxis against flares when initiating ULT.

Detailed description:
Clinical trials have demonstrated that anti-IL-1 agents (IL-1Ra, IL-1 Trap, and anti-IL-1β monoclonal antibody) can reduce the frequency of gout flares during the initial period of treatment with urate-lowering therapy and prevent of gout flares in gout patients with frequent flares. AC-201 is an oral IL-1 modulator but with a mechanism distinct from that of existing anti-IL-1 agents. The active metabolite of AC-201 has been shown in vitro and in vivo to inhibit the production and activity of IL-1, down-regulate IL-1 receptors, and increase IL1-Ra. Molecular research further suggests that these effects are mediated upstream via inhibition of MAPK signaling pathways and binding of NF-κB and AP-1 transcription factors that encode for a range of pro-inflammatory factors, including IL-1β, TNF-α, IL-6, IL-8, iNOS, and MMPs, which have been implicated in gout flares. AC-201 has also been demonstrated to have uric acid-lowering effects in clinical trials. The favorable product profile of AC-201 overall provides a strong rationale for investigating its clinical utility as prophylaxis against flares when initiating ULT.

Arms: arm 1: Placebo plus Febuxostat arm 2: AC-201 plus Febuxostat
Interventions: intervention 1: Placebo intervention 2: AC-201 intervention 3: Febuxostat
Intervention descriptions: intervention 1: Placebo Capsule BID for 16 Weeks intervention 2: AC-201 50mg Capsule BID for 16 Weeks intervention 3: Febuxostat 80 mg QD for 16 Weeks

Protocol documents:
Clinical trial NCT01720251
Conditions: Allergic Rhinitis Rhinoconjunctivitis
Keywords: allergic rhinitis birch pollen immunotherapy
Sponsor: Anergis
Start date: 2012-10-01; Completion date: 2013-09-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season

Detailed description:

Arms: arm 1: SC injections of placebo arm 2: SC injections of AllerT 25 or 50 micrograms arm 3: SC injections of AllerT 50-100 micrograms
Interventions: intervention 1: placebo intervention 2: AllerT low dose intervention 3: AllerT full dose
Intervention descriptions: intervention 1: SC injections of placebo on days 1, 7, 14, 28 and 56 intervention 2: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56 intervention 3: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56

Protocol documents:
Clinical trial NCT01727700
Conditions: Tourette's Disorder Tic Disorder
Keywords: Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Tic Disorders Tics Movement Disorders Mental Disorders Aripiprazole
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-11-01; Completion date: 2013-09-01
Enrollment: 133 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Detailed description:
Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Arms: arm 1: Matching Placebo Once-Daily arm 2: Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily arm 3: Aripiprazole 10 mg 20 mg Immediate Release Once-Daily
Interventions: intervention 1: Aripiprazole intervention 2: Placebo
Intervention descriptions: intervention 1: Once-daily, tablet intervention 2: None

Protocol documents: