ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00608777
Conditions: Plaque Psoriasis
Keywords: Localized mild breakthrough
Sponsor: Derm Research, PLLC
Start date: 2008-01-01; Completion date: 2009-02-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis.

It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.

Detailed description:
LMB (localized mild breakthrough)is one of two psoriasis adverse events commonly seen in efalizumab treated patients. It is generally papular in nature and does not involve existing lesions. Clinical experience suggests that LMB may not have a clinical impact in patients responding to efalizumab and therefore may be treated without interrupting efalizumab therapy. To relieve discomfort topical therapy may be indicated until the symptoms are resolved.

This is a single arm, open label study. Fifteen patients who are receiving efalizumab before entrance into this study and who develop LMB wil be enrolled. Topical calcipotriene/betamethasone (Taclonex) will be applied to the areas (except face, axillae or groin) once a day for two weeks. The PI may choose to continue two more weeks if needed for a total of four weeks of therapy. All patients will continue with efalizumab without dose modification for the duration of the study. Patients will return for follow up visits at weeks 2, 4 and 6. Topical desonide may be used for LMB involvement of the face, groin or axillae.

Interventions: intervention 1: Calcipotriene/betamethasone
Intervention descriptions: intervention 1: One application to affected areas, once a day for two weeks. The PI may choose to extend treatment until Week 4 if necessary.

Protocol documents:
Clinical trial NCT00614120
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2008-01-01; Completion date: 2009-02-01
Enrollment: 929 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

Detailed description:

Arms: arm 1: Liraglutide 0.6 mg + metformin + glimepiride placebo arm 2: Liraglutide 1.2 mg + metformin + glimepiride placebo arm 3: Liraglutide + metformin + glimepiride placebo arm 4: Glimepiride 4.0 mg + metformin + liraglutide placebo
Interventions: intervention 1: liraglutide intervention 2: placebo intervention 3: liraglutide intervention 4: liraglutide intervention 5: glimepiride intervention 6: metformin intervention 7: placebo
Intervention descriptions: intervention 1: 0.6 mg/day, s.c. (under the skin) injection intervention 2: Glimepiride placebo, capsules intervention 3: 1.2 mg/day, s.c. (under the skin) injection intervention 4: 1.8 mg/day, s.c. (under the skin) injection intervention 5: Capsules, 4.0 mg/day intervention 6: Tablets, 1.5-2.0 g/day intervention 7: Liraglutide placebo, s.c. (under the skin) injection

Protocol documents:
Clinical trial NCT00620074
Conditions: Aspergillosis
Keywords: invasive aspergillosis, opportunistic mold infection
Sponsor: Pfizer
Start date: 2008-08-01; Completion date: 2009-02-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will test the effectiveness and the safety of giving two antifungal agents (voriconazole and anidulafungin) together to treat invasive aspergillosis in patients who are unable to tolerate polyene therapy.

Detailed description:
The study was terminated on January 12, 2009 due to the overall low rate of enrollment. The decision to terminate the trial was not based on any safety concerns. Patients who were enrolled in the study prior to January 12, 2009 were allowed to remain in the study until completing their participation as specified in the protocol.

Arms: arm 1: anidulafungin plus voriconazole arm 2: anidulafungin plus voriconazole
Interventions: intervention 1: voriconazole intervention 2: anidulafungin
Intervention descriptions: intervention 1: Subjects with creatinine clearance at least 50 ml/min will receive initial treatment with IV (loading dose of 6 mg/kg Q12h followed by maintenance dose of 4 mg/kg Q12h) or oral (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance \<50 ml/min will receive oral voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). intervention 2: Loading dose of 200 mg QD followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy

Protocol documents:
Clinical trial NCT00620464
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2005-05-01; Completion date: 2009-02-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.

Detailed description:

Arms: arm 1: The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. arm 2: Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and

2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.

The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after

insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year.
Interventions: intervention 1: Radiopaque Implanon intervention 2: Implanon (etonogestrel implant)
Intervention descriptions: intervention 1: Radiopaque rod for 3 years intervention 2: Implanon (etonogestrel implant) for 3 years

Protocol documents:
Clinical trial NCT00621296
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Protease Inhibitor
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-01-01; Completion date: 2009-02-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MP-424 (Telaprevir)
Intervention descriptions: intervention 1: Three tablets of MP-424 250mg tablet at a time, every 8 hours, 24 weeks administration (dose in a day: 2250 mg)

Protocol documents:
Clinical trial NCT00631358
Conditions: Sjogren's Syndrome
Keywords: Ocular inflammation
Sponsor: Alcon Research
Start date: 2008-02-01; Completion date: 2009-02-01
Enrollment: 97 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.

Detailed description:

Arms: arm 1: Maxidex arm 2: Healthy normal control group receiving no treatment
Interventions: intervention 1: Maxidex intervention 2: No treatment
Intervention descriptions: intervention 1: Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily intervention 2: Healthy normal control group receiving no treatment

Protocol documents:
Clinical trial NCT00632502
Conditions: Neutrophilic Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-05-01; Completion date: 2009-02-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
4-Week Safety Study in Subjects with Neutrophilic Asthma

Detailed description:
Effect of treatment with navarixin (MK-7123, SCH 527123) on sputum neutrophils and asthma symptoms

Arms: arm 1: Navarixin (MK-7123, SCH 527123) 30 mg capsule, to be taken by mouth once daily in the morning for 4 weeks arm 2: Placebo capsule to match navarixin, to be taken by mouth once daily in the morning for 4 weeks
Interventions: intervention 1: Navarixin intervention 2: Placebo intervention 3: Rescue medication
Intervention descriptions: intervention 1: Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks. intervention 2: Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks. intervention 3: Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms

Protocol documents:
Clinical trial NCT00633126
Conditions: Infection
Keywords: PK Pharmacokinetics
Sponsor: Forest Laboratories
Start date: 2008-03-01; Completion date: 2009-02-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects

Detailed description:
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects

Arms: arm 1: ceftaroline
Interventions: intervention 1: ceftaroline
Intervention descriptions: intervention 1: Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.

Protocol documents:
Clinical trial NCT00633217
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: DISKUS Salmeterol Fluticasone Propionate Chronic Obstructive Pulmonary Disease (COPD) Hydroflouroalkane COPD HFA MDI
Sponsor: GlaxoSmithKline
Start date: 2008-03-01; Completion date: 2009-02-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of the FSC HFA MDI in subjects with COPD. The dose of FSC HFA MDI to be evaluated corresponds to the dose of FSC DISKUS (250/50mcg twice-daily) that is indicated for the treatment of COPD associated with chronic bronchitis in the US. This study will last up to approximately 15 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests and will record their peak expiratory flow measurements daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The FSC HFA MDI used in this study has been approved by FDA for use in asthma while the FSC 250/50mcg DISKUS has been approved for use in asthma and COPD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fluticasone Propionate/Salmeterol DISKUS 250/50mcg intervention 2: Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a MDI 230/42mcg
Intervention descriptions: intervention 1: treatment drug intervention 2: treatment drug

Protocol documents:
Clinical trial NCT00634283
Conditions: Depression
Sponsor: University of California, Los Angeles
Start date: 2008-02-01; Completion date: 2009-02-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines the effects of an antidepressant medication and placebo on the brain functioning of normal subjects. In this study, recordings of brain electrical activity are being used to detect and monitor the response to treatment with venlafaxine IR (Effexor), a drug used for the treatment of depression. The intent of this study is to test specific hypotheses regarding:

1. long-term brain effects of a single course of antidepressant treatment
2. pharmaco-conditioning effects underlying antidepressant tolerance/sensitization
3. brain functional response to initial versus subsequent antidepressant trials in normal healthy subjects.

Detailed description:
Major Depressive Disorder (MDD) is a lifelong and recurrent illness, such that many individuals require multiple courses of antidepressant medication treatment. While some patients respond completely to each course of treatment, many do not, and with each unsuccessful antidepressant trial the likelihood that a patient will respond decreases. This raises the possibility that neurophysiologic response in subsequent antidepressant treatment may be influenced by learning processes including sensitization, habituation, and/or classical conditioning. Classical conditioning would entail the association of cues such as pill-taking (conditioned stimuli; CS) with the effects of active medication (unconditioned stimulus; US), such that later presentation of the CS alone would come to elicit a conditioned response (CR). Such effects could be revealed by blinded administration of placebo following a period of treatment with active medication. Habituation effects (tolerance), or sensitization effects (increased response), which require only repeated exposure to a stimulus, might be evidenced after repeated courses of antidepressant treatment. Knowledge of how learning processes impact neurophysiologic response to successive courses of antidepressant treatment would have relevance for clinical populations. Specific hypotheses, however, may be tested in healthy non-clinical samples to avoid potential confounding factors related to severity or chronicity of illness. Learning theories would suggest two hypotheses: (1) neurophysiologic response to placebo will differ between subjects who were previously treated with antidepressant treatment as compared to placebo (classical conditioning hypothesis); and (2) neurophysiologic response to an initial course of antidepressant treatment will differ from response to a repeated course of antidepressant treatment.

Arms: arm 1: Subjects who had previously been exposed to active antidepressant medication (venlafaxine) arm 2: Subjects who had previously been exposed to placebo only (and never to active antidepressant medication)
Interventions: intervention 1: venlafaxine
Intervention descriptions: intervention 1: venlafaxine IR 150mg

Protocol documents:
Clinical trial NCT00638027
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
Sponsor: University of Rochester
Start date: 2006-07-01; Completion date: 2009-02-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Participants (n=20) will be identified at routine care visits performed at the Rochester Multiple Sclerosis Center. Eligible participants will have MS by McDonald Criteria,7 and will have a modified Ashworth spasticity rating8 of two or higher in at least one lower extremity muscle group. Participants will be seen at screening, one, and three months, and will be evaluated using the modified Ashworth scale,8 pendulum test,9 toe tapping test,10 manual muscle testing,11 timed 25 foot walk,12 and Multiple Sclerosis Functional Composite.13 The type and severity of any adverse events will be recorded using standard definitions. Participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. Follow-up will continue until all adverse events resolve or stabilize.

Detailed description:
This is a randomized, placebo controlled, double-blind, parallel group trial of memantine in patients with MS and spasticity. Participants will be identified at routine care visits at the Rochester Multiple Sclerosis Center. After obtaining informed consent, patients will undergo screening, which will include a physical/neurologic exam and an assessment of the Expanded Disability Status Scale, spasticity, and functional abilities. Eligible patients will return for a baseline evaluation, will initiate their randomly assigned study medication, and will return after one and three months for re-evaluation. The type and severity of any adverse events will be recorded using standard definitions. Participants will be instructed to call between visits to inform the investigators regarding any adverse events they experience. Follow-up will continue until all adverse events resolve or stabilize.

Arms: arm 1: Memantine 10 mg bid arm 2: Placebo
Interventions: intervention 1: placebo intervention 2: memantine
Intervention descriptions: intervention 1: matched tablets bid intervention 2: 10 mg bid

Protocol documents:
Clinical trial NCT00643760
Conditions: Neuropathy, Diabetic
Keywords: Peripheral Diabetic Neuropathy (PDN) Neuropathic Pain
Sponsor: XenoPort, Inc.
Start date: 2008-03-01; Completion date: 2009-02-01
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)

Detailed description:
This is a dose-response study of XP13512 compared with concurrent placebo control and LYRICA (pregabalin), in subjects with neuropathic pain associated with DPN. Three doses of XP13512 (1200 mg/day, 2400 mg/day and 3600 mg/day) are being evaluated for the management of neuropathic pain associated with DPN. Approximately 392 subjects from 70 to 80 participating sites in the US will be randomized to receive either XP13512 at the above mentioned doses, placebo or pregabalin (300mg/day).

Arms: arm 1: Placebo arm 2: Pregabalin 300mg/day (positive control), maintenance treatment 14 weeks arm 3: gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks arm 4: gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks arm 5: gabapentin enacarbil 3600mg/day, maintanance treatment 14 weeks
Interventions: intervention 1: Placebo intervention 2: GEn 1200mg/day intervention 3: GEn 2400mg/day intervention 4: GEn 3600mg/day intervention 5: Pregabalin
Intervention descriptions: intervention 1: placebo intervention 2: gabapentin enacarbil 1200mg/day intervention 3: gabapentin enacarbil 2400mg/day intervention 4: gabapentin enacarbil 3600mg/day intervention 5: pregabalin 300mg/day

Protocol documents:
Clinical trial NCT00654940
Conditions: Nerve Pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-05-01; Completion date: 2009-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents

Detailed description:
Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin (Lyrica) intervention 2: Placebo
Intervention descriptions: intervention 1: Oral, 75mg or 150mg capsules, BID intervention 2: Oral, matched capsules, BID

Protocol documents:
Clinical trial NCT00655629
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Sponsor: Bayer
Start date: 2008-04-01; Completion date: 2009-02-01
Enrollment: 339 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Detailed description:

Arms: arm 1: Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. arm 2: Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Interventions: intervention 1: Vardenafil ODT (STAXYN, BAY38-9456) intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT) intervention 2: Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Protocol documents:
Clinical trial NCT00664859
Conditions: Dyslipidemia
Keywords: LCP-AtorFen Non-HDL cholesterol Triglycerides HDL cholesterol LDL cholesterol Atorvastatin Fenofibrate
Sponsor: Veloxis Pharmaceuticals
Start date: 2007-10-01; Completion date: 2009-02-01
Enrollment: 140 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia

Detailed description:
POPULATION:

Subjects with mixed dyslipidemia (non-HDL cholesterol \> 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label extension study.

STUDY DESIGN AND DURATION:

This is a 52-week, open-label, single-treatment arm with 8 visits (Weeks 0, 4, 8, 12, 24, 36, 48 and 52). A maximum of approximately 200 subjects will enter this open-label safety and efficacy extension study from the LCP AtorFen-2001 double-blind study. All subjects enrolled in this study will receive open-label LCP-AtorFen combination therapy. Visit 1 of the extension study corresponds to the last visit of the double-blind study (Visit 6 or Week 12).

Arms: arm 1: Open-label LCP-AtorFen
Interventions: intervention 1: LCP-AtorFen
Intervention descriptions: intervention 1: All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals.

Protocol documents:
Clinical trial NCT00666679
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2008-05-01; Completion date: 2009-02-01
Enrollment: 134 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Detailed description:
During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.

Arms: arm 1: mometasone arm 2: montelukast followed by placebo; or placebo followed by montelukast.
Interventions: intervention 1: Comparator: mometasone intervention 2: Comparator: montelukast intervention 3: Comparator: placebo (unspecified)
Intervention descriptions: intervention 1: mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks) intervention 2: montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks) intervention 3: Placebo (Placebo once-daily, for approximately 2 weeks)

Protocol documents: