ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00881205
Conditions: Multiple Sclerosis Cognitive Impairment
Keywords: Multiple Sclerosis Cognition Rivastigmine Patch
Sponsor: Novartis Pharmaceuticals
Start date: 2009-04-01; Completion date: 2011-01-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in cognitively impaired Multiple Sclerosis (MS) patients. Primary objective was the assessment of cognition by the Selective Reminding Test (SRT) -a subtest of the brief repeatable battery (BRB) - after titration of 4 weeks and maintenance of 12 weeks. This double-blind period was followed by a 52-week open-label treatment phase to assess long-term safety of rivastigmine patch in these patients.

Detailed description:

Arms: arm 1: Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. arm 2: Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.
Interventions: intervention 1: Rivastigmine transdermal patch intervention 2: Placebo
Intervention descriptions: intervention 1: Transdermalapplication of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. All patches are round, beige in color. intervention 2: Transdermal application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. Matching the size, shape and color of rivastigmine patches.

Protocol documents:
Clinical trial NCT00886769
Conditions: Systemic Juvenile Idiopathic Arthritis
Keywords: Flare arthritis IL-1beta antagonist systemic juvenile idiopathic arthritis Juvenile Rheumatoid Systemic juvenile idiopathic arthritis with active flare
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2011-01-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

Detailed description:

Arms: arm 1: Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections. arm 2: Patients received a single dose matching placebo of canakinumab on day 1.
Interventions: intervention 1: Canakinumab intervention 2: Placebo
Intervention descriptions: intervention 1: Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL. intervention 2: Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.

Protocol documents:
Clinical trial NCT00905255
Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia GLP-1
Sponsor: Sanofi
Start date: 2009-05-01; Completion date: 2011-01-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) used as 2-step initiation regimen and 1-step initiation regimen in Japan, over a period of 24 weeks of treatment, followed by an extension up to Week 76.

The primary objective of this study is to evaluate the safety of lixisenatide once daily treatment in monotherapy at Week 24 by a descriptive comparison of a 1-step initiation and a 2-step initiation regimen in patients with type 2 diabetes in Japan.

The secondary objectives are to assess the overall safety of lixisenatide once daily treatment in monotherapy at Week 52 and Week 76; to assess the effects of lixisenatide on glycosylated hemoglobin (HbA1c) reduction at Week 52 and Week 76, body weight, and fasting plasma glucose (FPG); to assess pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed description:

Arms: arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment. arm 2: 1-step initiation regimen of lixisenatide: 10 mcg QD for 2 weeks, then 20 mcg QD up to end of treatment.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Pen auto-injector
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: None

Protocol documents:
Clinical trial NCT00906347
Conditions: Labor Augmentation
Keywords: Labor augmentation Oral misoprostol
Sponsor: University of Texas Southwestern Medical Center
Start date: 2008-12-01; Completion date: 2011-01-01
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.

Detailed description:

Arms: arm 1: Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin. arm 2: Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Interventions: intervention 1: Misoprostol intervention 2: Oxytocin
Intervention descriptions: intervention 1: 75 micrograms orally every 4 hours for up to 2 doses. intervention 2: Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital

Protocol documents:
Clinical trial NCT00926952
Conditions: Actinic Keratosis
Keywords: Actinic keratoses actinic keratosis methylamonolevulinate photodynamic therapy without occlusion short incubation
Sponsor: Innovaderm Research Inc.
Start date: 2009-07-01; Completion date: 2011-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Actinic keratoses on the face are often numerous and widespread. The application of Methylaminolevulinate (MAL) on individual lesions followed by the application of a plastic film on each lesion is difficult and takes time for subjects with many actinic keratoses. The waiting period of 3 hours between MAL cream application and red light exposure is also long for patients. The goal of this study is to evaluate the safety and efficacy of photodynamic therapy (PDT) with MAL with a shorter cream application time (90 minutes) and when MAL is applied on the entire face without the plastic film.

Detailed description:
A total of 20 patients with at least 5 non-hypertrophic actinic keratoses (AK) of the face were included in this open-label study. All AKs were mapped on a transparent template before the first PDT treatment. At Day 0, all patients received methylaminolevulinate (MAL) applied on the entire face (except the nose and peri-ocular area of 1-2 cm) without any skin preparation. One to two 2 g MAL tubes was used for the entire face. MAL was applied without occlusion. After a total of 90 +/- 5 minutes the skin was rinsed and exposed to 37 J/cm² of red light from an Aktilite™ device. Patients were seen at Week 4; if all facial AKs did not show a complete response to treatment, the MAL-PDT procedure was repeated at Week 4. Patients were seen again at Week 12 and 24.

The primary endpoint was at Week 12. Patients came back at Week 24 for a final safety evaluation and to verify the recurrence of AK.

Efficacy is evaluated by assessing the mean number of facial AK at Week 12 as compared to Day 0.

Arms: arm 1: Patients had 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and waited 90 minutes prior to photodynamic therapy (PDT) using red light.
Interventions: intervention 1: Methylaminolevulinate (Metvix, Metvixia) intervention 2: Photodynamic Therapy (Aktilite)
Intervention descriptions: intervention 1: 2-4 g of cream applied to entire face at Day 0 for 90 minutes without occlusion prior to light treatment. If any actinic keratoses remained after 4 weeks the treatment was repeated at Week 4. intervention 2: Device set to 37 J/cm². Red light wavelength is approximately 630 nm.

Protocol documents:
Clinical trial NCT00928304
Conditions: Down Syndrome Amyloid Beta-protein
Keywords: Amyloid beta-protein Down Syndrome
Sponsor: Life Molecular Imaging SA
Start date: 2009-06-01; Completion date: 2011-01-01
Enrollment: 109 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Florbetaben (BAY94-9172)
Intervention descriptions: intervention 1: 300 megabecquerels (MBq) as single IV injection of 2 to 10 mL

Protocol documents:
Clinical trial NCT00929578
Conditions: Psoriasis
Keywords: Psoriasis T-lymphocytes Fluphenazine
Sponsor: Tufts Medical Center
Start date: 2008-11-01; Completion date: 2011-01-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine in adult subjects with psoriasis.

Detailed description:
This is a double-blind, placebo-controlled, bilateral, ascending dose study.

In vitro, fluphenazine has been shown to suppress growth of proliferating T-lymphocytes. Fluphenazine would be expected to also suppress growth of proliferating T-lymphocytes in psoriatic plaques.

Arms: arm 1: The sterile placebo: Bacteriostatic Sodium Chloride for Injection. arm 2: This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
Interventions: intervention 1: Fluphenazine intervention 2: Placebo
Intervention descriptions: intervention 1: Intralesional injection of Fluphenazine intervention 2: Intralesional injection of placebo

Protocol documents:
Clinical trial NCT00944658
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis Imaging
Sponsor: Imperial College London
Start date: 2009-08-01; Completion date: 2011-01-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of apremilast in AS as measured by improvement in patients' signs and symptoms of the disease and changes in imaging. Additionally the safety and tolerability of apremilast in AS will be assessed.

Detailed description:
Presently, there are very few treatments available which affect the progression of the disease in the spine. The only proven treatment is the use of drugs inhibiting tumour necrosis factor alpha (TNF). However, there are limitations with this treatment in that it needs to be administered via an injection and is also very expensive. Therefore it is necessary to develop new therapeutic agents for this condition.

Apremilast (the study drug) is an oral tablet which has been shown to inhibit TNF production in a mouse model of inflammation. It has also been used in clinical trials for asthma and psoriasis in humans with good affect and tolerability.

These studies were funded by Celgene Corporation and they will be funding this study.

The patients will be recruited from hospitals by Consultant referral. The patients will have had AS for at least 2 years and their symptoms will have been uncontrolled on conventional non-steroidal anti-inflammatory drugs such as ibuprofen. Patients will be randomised to either receive apremilast or a placebo and treated over a period of 12 weeks. They will then be followed up for 28 days after the treatment period.

Arms: arm 1: placebo twice a day for 12 weeks, 4 weeks follow up arm 2: 30 mg twice a day for 12 weeks, 4 weeks follow up
Interventions: intervention 1: Apremilast intervention 2: Placebo (sugar pill)
Intervention descriptions: intervention 1: 10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks intervention 2: twice a day

Protocol documents:
Clinical trial NCT00961636
Conditions: Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-10-01; Completion date: 2011-01-01
Enrollment: 1152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.

Detailed description:

Arms: arm 1: One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg

tablets daily (2g/40 mg total) for 28 weeks arm 2: One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks. arm 3: One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
Interventions: intervention 1: ER niacin (+) laropiprant (ERN/LRPT) intervention 2: ER niacin (+) laropiprant (ERN/LRPT) intervention 3: Extended-release niacin (ERN) intervention 4: Placebo to ERN/LRPT
Intervention descriptions: intervention 1: One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks intervention 2: One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks. intervention 3: Two 1g tablets ERN (2g total) once daily for 12 weeks. intervention 4: One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks

Protocol documents:
Clinical trial NCT00965523
Conditions: Breast Cancer
Keywords: Cancer breast cancer neoplasm E7389 Eribulin
Sponsor: Eisai Co., Ltd.
Start date: 2008-01-01; Completion date: 2011-01-01
Enrollment: 81 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study (E7389-J081-224; hereafter referred to as Study 224) is to evaluate the safety of patients who continue to receive E7389 after completing the Phase II clinical study (E7389-J081-221; hereafter referred to as Study 221) of E7389 for advanced or relapsed breast cancer by intravenously administering E7389.

Detailed description:
Study 224 (Extension Period) was designed to evaluate the safety and efficacy of E7389 by collecting data from subjects who continued receiving E7389 after being transferred from Study 221 (Core Period). Thus, efficacy analyses performed in Study 221 were updated and reported with the additional data collected in Study 224. Objective response rate (ORR) and the number of subjects with adverse events are reported as outcome measures because these were the outcome measures of Study 221 which is a main study in the combined data. Also, safety analyses performed in Study 221 were updated and reported with the additional data collected in Study 224.

Arms: arm 1: None
Interventions: intervention 1: Eribulin Mesylate
Intervention descriptions: intervention 1: Eribulin mesylate 1.4 mg/m\^2 intravenous infusion (IV) given over 2 to 5 minutes on Day 1 and 8 every 21 days.

Protocol documents:
Clinical trial NCT00970632
Conditions: Benign Prostatic Hyperplasia (BPH)
Sponsor: Eli Lilly and Company
Start date: 2009-10-01; Completion date: 2011-01-01
Enrollment: 511 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with Benign Prostatic Hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)

Detailed description:

Arms: arm 1: Placebo tablet with tamsulosin dose orally (po) once daily (QD) and placebo capsule with tadalafil dose po QD for 12 weeks arm 2: Tadalafil 5 mg tablet po QD and placebo capsule po QD for 12 weeks arm 3: Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
Interventions: intervention 1: Tadalafil 5 mg intervention 2: Placebo tablet intervention 3: Tamsulosin intervention 4: Placebo capsule
Intervention descriptions: intervention 1: Tadalafil 5 mg po QD for 12 weeks intervention 2: Placebo tablet po QD for 12 weeks intervention 3: Tamsulosin 0.4 mg po QD for 12 weeks intervention 4: Placebo capsule po QD for 12 weeks

Protocol documents:
Clinical trial NCT00986258
Conditions: Pain Chronic Pain Low Back Pain Neuropathic Pain Nociceptive Pain
Keywords: pain assessment tapentadol centrally acting analgesic
Sponsor: Grünenthal GmbH
Start date: 2009-10-30; Completion date: 2011-01-01
Enrollment: 136 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride prolonged release treatment during defined periods of evaluation.

Detailed description:

Arms: arm 1: Other Names:

* Nucynta
* Palexia
Interventions: intervention 1: Tapentadol Prolonged Release
Intervention descriptions: intervention 1: Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows:

* if less than 100 mg morphine equivalent start with 50 mg tapentadol PR;
* if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapentadol PR;
* if above 161 mg morphine equivalent daily dose start with 150 mg tapentadol PR.

Tapentadol doses were adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis). After 5 weeks, the doses of tapentadol PR were kept stable (start of Maintenance phase). The tapentadol PR formulation was administered for up to 12 weeks. Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol PR was reached.

Protocol documents:
Clinical trial NCT00990938
Conditions: Hepatitis C, Treatment Naïve, Genotype 1 Patients
Sponsor: Idera Pharmaceuticals, Inc.
Start date: 2009-09-01; Completion date: 2011-01-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).

Detailed description:
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard ribavirin or placebo plus ribavirin. Each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo and ribavirin. Three varying dose levels of IMO-2125 will be included. In both arms, ribavirin will be dosed based on patient weight.

Approximately 50 patients will be enrolled in France and Russia. Patients will provide informed consent prior to any screening procedures being performed. Screening will occur within 21 days prior to randomization. Enrolled patients who qualify and proceed successfully through the screening period will be randomized to receive 4 weeks of either the investigational treatment arm (IMO-2125 and ribavirin) or placebo and ribavirin, with a 4 week follow-up period.

Patients who are randomized to the investigational treatment arm will receive one of 3 dose levels of IMO 2125 SC once weekly; each patient will receive the same dose throughout the 4 weeks of treatment. In addition to IMO-2125 treatment they will also receive daily ribavirin, which will be given based on the patients weight and will be taken twice daily for a total of 4 weeks.

Arms: arm 1: If randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks arm 2: If randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks
Interventions: intervention 1: IMO-2125 intervention 2: Saline
Intervention descriptions: intervention 1: IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system. intervention 2: Subcutaneous injection once per week for four weeks

Protocol documents:
Clinical trial NCT00995345
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes Metformin
Sponsor: ActivX Biosciences, Inc.
Start date: 2009-10-01; Completion date: 2011-01-01
Enrollment: 403 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and effectiveness of KRP-104 on glycemic control in patients with type 2 diabetes inadequately controlled on metformin alone.

Detailed description:

Arms: arm 1: Tablet, once-daily for 24 weeks arm 2: Tablet, once-daily for 24 weeks arm 3: Tablet, once-daily for 24 weeks arm 4: Tablet, once-daily for 24 weeks (dose switch from 20 to 120 mg at week 12) arm 5: Tablet, once-daily for 24 weeks
Interventions: intervention 1: KRP-104 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT01011283
Conditions: Myelodysplastic Syndromes
Keywords: MDS Myelodysplastic Syndromes
Sponsor: Eisai Inc.
Start date: 2009-11-01; Completion date: 2011-01-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: decitabine intervention 2: azacitidine
Intervention descriptions: intervention 1: decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days intervention 2: azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days

Protocol documents: