ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00604500
Conditions: Asthma COPD
Sponsor: Organon and Co
Start date: 2008-03-01; Completion date: 2008-11-01
Enrollment: 272 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.

Detailed description:

Arms: arm 1: MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MFF MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.
Interventions: intervention 1: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )
Intervention descriptions: intervention 1: MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.

Protocol documents:
Clinical trial NCT00638716
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin
Sponsor: ConjuChem
Start date: 2008-02-01; Completion date: 2008-11-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study.

The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin monotherapy.

Detailed description:

Arms: arm 1: 12 weekly doses of 1.5 mg CJC-1134-PC arm 2: 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC arm 3: 12 weekly doses of placebo
Interventions: intervention 1: CJC-1134-PC intervention 2: Placebo
Intervention descriptions: intervention 1: 1.5 or 2.0 mg CJC-1134-PC intervention 2: Placebo

Protocol documents:
Clinical trial NCT00641186
Conditions: Parkinson Disease
Keywords: excessive daytime somnolence Parkinson disease sleep disturbance
Sponsor: Baylor College of Medicine
Start date: 2004-09-01; Completion date: 2008-11-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease (PD).

Detailed description:
Inclusion required an Epworth Sleepiness Scale (ESS) score greater than 10 and any subjective nocturnal sleep concern, usually insomnia. An acclimation and screening polysomnogram was performed to exclude subjects with sleepdisordered breathing. The following evening, subjects underwent another polysomnogram, followed by an evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) while practically defined off ("off") PD medications, ESS (primary efficacy point), Pittsburgh Sleep Quality Inventory, and Fatigue Severity Scale. Subjects then started sodium oxybate therapy, which was titrated from 3 to 9 g per night in split doses (at bedtime and 4 hours later) across 6 weeks, and returned for subjective sleep assessments. They then returned at 12 weeks after initiating therapy for a third polysomnogram, an offmedication UPDRS evaluation, and subjective sleep assessments. Data are expressed as mean (SD).

Arms: arm 1: sodium oxybate 4.5 to 9.0 gms per night
Interventions: intervention 1: sodium oxybate
Intervention descriptions: intervention 1: 4.5 to 9.0 grams per night

Protocol documents:
Clinical trial NCT00654875
Conditions: Essential Hypertension
Keywords: Essential Hypertension
Sponsor: Novartis
Start date: 2008-03-01; Completion date: 2008-11-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension

Detailed description:

Arms: arm 1: Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks. arm 2: Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.
Interventions: intervention 1: Aliskiren intervention 2: Placebo to Aliskiren
Intervention descriptions: intervention 1: Aliskiren supplied in 150 mg and 300 mg tablets. intervention 2: Placebo to Aliskiren matching 150 and 300 mg tablets

Protocol documents:
Clinical trial NCT00660985
Conditions: Acne Vulgaris
Keywords: Acne vulgaris Differin Adapalene
Sponsor: Galderma R&D
Start date: 2008-05-01; Completion date: 2008-11-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.

Detailed description:
Multi-center, double-blind, randomized, parallel group study enrolling male or female subjects with acne vulgaris.

Screening will take place within 14 days prior to Baseline. At the Baseline visit, and at each study day up to Day 30, a trained nurse or technician will apply 2 grams of study medication (either Differin® Gel, 0.3% or Differin® Gel, 0.1%) to the face, upper part of chest, and upper part of back of the subjects. To ensure maximal usage conditions, 2 grams study medication will be applied once daily to a total body surface area of approximately 1000 cm², which is equivalent to 2 mg/cm2.

Subjects will arrive at the clinic the night before on visit days (Day 1, Day 15 and Day 30) when PK blood samples will be drawn. Subjects will be discharged from the clinic on Day 2 and Day 16 following the 24-hour post-dose blood sample, and on Day 31 after the 36-hour post-dose blood samples.

Cutaneous safety (local tolerability assessments) will be assessed, by recording erythema, scaling, dryness, and stinging/burning sensation as separate scores on the face, upper part of the chest, and upper part of the back using a 4-point scale (0 = None to 3 = Severe). Local tolerability assessments will be performed weekly on Day 1, 8, 15, 22 and Day 30, prior application of study medication.

Efficacy will be evaluated by Inflammatory and Non-inflammatory lesion counts on the face performed at Screening, Baseline (Day 1), and on Day 30.

Subjects will have routine laboratory tests (fasting hematology, blood chemistry) performed at Screening and at Day 30 visits.

Blood samples for determination of adapalene plasma concentrations will be drawn on Day 1, Day 15, and Day 30 before the morning study medication application (pre-dose) and 1, 2, 4, 6, 8, 10, 12, 16 and 24 hours after application of study medication; and additionally after the last study medication application (Day 31, 32, 33) at 32, 36, 48 and 72 hours post-dose.

The adapalene plasma concentrations will be determined by a high performance liquid chromatography (HPLC) and fluorescence detection method.

Arms: arm 1: Gel, 0.3%, 2g, once daily for 30 days arm 2: Gel, 0.1%, 2g, once daily for 30 days
Interventions: intervention 1: Adapalene intervention 2: Adapalene
Intervention descriptions: intervention 1: Gel, 0.3%, 2g, once daily for 30 days intervention 2: Gel, 0.1%, 2g, once daily for 30 days

Protocol documents:
Clinical trial NCT00669903
Conditions: Schizophrenia
Sponsor: AstraZeneca
Start date: 2008-04-01; Completion date: 2008-11-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia

Detailed description:

Arms: arm 1: AZD0328 low dose arm 2: AZD0328 Optimal dose arm 3: AZD0328 High dose arm 4: Placebo Comparator
Interventions: intervention 1: AZD0328 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00669942
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: Novartis Pharmaceuticals
Start date: 2005-12-01; Completion date: 2008-11-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.

Detailed description:

Arms: arm 1: AIN457A 0.3 mg/kg was administered intravenously as a single dose. arm 2: AIN457A 1.0 mg/kg was administered intravenously as a single dose. arm 3: AIN457A 3.0 mg/kg was administered intravenously as a single dose. arm 4: AIN457A 10.0 mg/kg was administered intravenously as a single dose. arm 5: Placebo to AIN457A was administered intravenously as a single dose. arm 6: AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 7: AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 8: AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 9: Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 10: AIN457A 3.0 mg/kg was administered intravenously as a single dose. arm 11: AIN457A 10 mg/kg was administered intravenously as a single dose. arm 12: Placebo to AIN457A was administered intravenously as a single dose.
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A. intervention 2: Placebo to AIN457

Protocol documents:
Clinical trial NCT00674466
Conditions: Type 2 Diabetes Mellitus
Keywords: GLP-1, incretin, type 2 diabetes
Sponsor: ConjuChem
Start date: 2008-03-01; Completion date: 2008-11-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients who are currently on metformin monotherapy.

Detailed description:

Arms: arm 1: Twice-a-week dose of 1.5 mg CJC-1134-PC arm 2: Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo arm 3: Twice-a-week placebo for CJC-1134-PC
Interventions: intervention 1: 1.5 mg or 2.0 mg CJC-1134-PC intervention 2: Placebo
Intervention descriptions: intervention 1: twice-a-week intervention 2: twice-a-week

Protocol documents:
Clinical trial NCT00681629
Conditions: Schizophrenia Schizoaffective Disorder Schizophreniform Disorder
Keywords: Schizophrenia Integrated Care Quetiapine
Sponsor: AstraZeneca
Start date: 2008-07-01; Completion date: 2008-11-01
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month

Detailed description:

Arms: arm 1: Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion arm 2: Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
Interventions: intervention 1: Quetiapine XR intervention 2: Integrated Care Program (ICP)
Intervention descriptions: intervention 1: 400-800 mg, oral, bid intervention 2: Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.

Protocol documents:
Clinical trial NCT00686894
Conditions: Spondylitis, Ankylosing SpA
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-01-01; Completion date: 2008-11-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects will be given 3 infusions of infliximab according to the label at week 0, 2, and 6. Subjects will be followed for a maximum of 18 weeks or until relapse. This study will assess the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis response and relapse in subjects treated with infliximab.

Detailed description:

Arms: arm 1: Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
Interventions: intervention 1: PDUS intervention 2: Infliximab
Intervention descriptions: intervention 1: PDUS scored for each enthesitis every 2 weeks for 24 weeks. intervention 2: * 5 mg/kg
* IV
* Frequency : weeks 0,2,6

Protocol documents:
Clinical trial NCT00689052
Conditions: Fibromyalgia
Sponsor: Boehringer Ingelheim
Start date: 2008-07-01; Completion date: 2008-11-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.

The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.

Detailed description:

Arms: arm 1: 0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening arm 2: Placebo tablets, once daily in the evening
Interventions: intervention 1: pramipexole ER intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00693017
Conditions: Epilepsy
Sponsor: Eisai Limited
Start date: 2008-06-01; Completion date: 2008-11-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myoclonic seizures. The total planned trial duration will be 6.5 months. After that, subjects who have completed the study will be eligible to enroll in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-318).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Zonisamide intervention 2: Placebo
Intervention descriptions: intervention 1: 50-400 mg capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks) intervention 2: 50-400 mg Zonisamide Placebo capsules once daily in the evening orally.

Maximum study duration 28 weeks comprising:

Baseline Period (Week -8 to Week 0): no treatment

Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)

Down Titration Period (4 Weeks)

Protocol documents:
Clinical trial NCT00703781
Conditions: Cataract
Keywords: Cataract extraction with intraocular lens implantation
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-06-01; Completion date: 2008-11-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Detailed description:

Arms: arm 1: Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily arm 2: Placebo, Dosed 1 Drop Daily
Interventions: intervention 1: bromfenac ophthalmic solution intervention 2: placebo
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution

Protocol documents:
Clinical trial NCT00716092
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-07-01; Completion date: 2008-11-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.

Detailed description:

Arms: arm 1: Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin. arm 2: Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin. arm 3: Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.
Interventions: intervention 1: Placebo (linagliptin) intervention 2: Placebo (linagliptin) intervention 3: Sitagliptin intervention 4: Placebo (sitagliptin) intervention 5: Placebo (sitagliptin) intervention 6: Linagliptin
Intervention descriptions: intervention 1: once daily for 28 days intervention 2: once daily for 28 days intervention 3: 100 mg once daily for 28 days intervention 4: once daily for 28 days intervention 5: once daily for 28 days intervention 6: 5mg once daily for 28 days

Protocol documents:
Clinical trial NCT00717067
Conditions: Human Immunodeficiency Virus (HIV) Infection
Keywords: maraviroc, pharmacokinetics, renal impairment
Sponsor: ViiV Healthcare
Start date: 2008-07-01; Completion date: 2008-11-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.

Detailed description:

Arms: arm 1: Subjects with Normal Renal Function (Creatinine Clearance \> 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir arm 2: Subjects with Mild Renal Impairment (Creatinine Clearance \>50 and ≤80 mL/min) arm 3: Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min) arm 4: Subjects with Severe Renal Impairment (Creatinine Clearance \<30 mL/min) arm 5: Subjects with End Stage Renal Impairment receiving Hemodialysis(Creatinine Clearance \<30 mL/min) (I) Maraviroc single dose one hour following completion of hemodialysis, followed by (II) Maraviroc single dose three hours prior to start of hemodialysis
Interventions: intervention 1: Maraviroc intervention 2: Maraviroc intervention 3: Ritonavir intervention 4: Saquinavir intervention 5: Maraviroc intervention 6: Ritonavir intervention 7: Saquinavir intervention 8: Maraviroc intervention 9: Ritonavir intervention 10: Saquinavir intervention 11: Maraviroc intervention 12: Maraviroc intervention 13: Maraviroc
Intervention descriptions: intervention 1: Maraviroc 300 mg (150 mg x 2 tablets) x single dose intervention 2: Maraviroc 150 mg tablet twice daily x 7 days intervention 3: Ritonavir 100 mg capsule twice daily x 7 days intervention 4: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 5: Maraviroc 150 mg tablet once daily x 7 days intervention 6: Ritonavir 100 mg capsule twice daily x 7 days intervention 7: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 8: Maraviroc 150 mg tablet once every 48 hours x 7 days intervention 9: Ritonavir 100 mg capsule twice daily x 7 days intervention 10: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 11: Maraviroc 300 mg (150 mg x 2 tablets) x single dose intervention 12: Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis intervention 13: Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis

Protocol documents:
Clinical trial NCT00729053
Conditions: Renal Cell Carcinoma
Keywords: renal cell renal carcinoma metastatic recurrent treatment naive
Sponsor: Idera Pharmaceuticals, Inc.
Start date: 2004-06-01; Completion date: 2008-11-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
* Multi-Center
* Randomized
* Open-Label Study of single agent IMO-2055
* Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)

Detailed description:
This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.

Arms: arm 1: Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg arm 2: Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg arm 3: Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg arm 4: Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
Interventions: intervention 1: IMO-2055
Intervention descriptions: intervention 1: immunostimulatory oligonucleotide

Protocol documents:
Clinical trial NCT00732381
Conditions: Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2008-08-01; Completion date: 2008-11-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray
Interventions: intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray
Intervention descriptions: intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Protocol documents: