ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01156844
Conditions: Persistent Asthma
Keywords: Indacaterol Asthma Bronchodilation Beta-agonist
Sponsor: Novartis Pharmaceuticals
Start date: 2010-03-01; Completion date: 2010-07-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Detailed description:

Arms: arm 1: Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days.

All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 2: Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days.

All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 3: Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days.

All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 4: Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days.

All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol intervention 2: Placebo to Indacaterol
Intervention descriptions: intervention 1: Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme. intervention 2: Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.

Protocol documents:
Clinical trial NCT01159171
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-01-01; Completion date: 2010-07-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: capecitabine [Xeloda] intervention 3: oxaliplatin
Intervention descriptions: intervention 1: 5 mg/kg intravenously every 14 days intervention 2: 1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle intervention 3: 40 mg/m2 iv weekly

Protocol documents:
Clinical trial NCT01201343
Conditions: Multiple Sclerosis, Relapsing, Remitting
Keywords: Multiple sclerosis, relapsing, remitting Interferon-beta
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-01-01; Completion date: 2010-07-01
Enrollment: 79 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is planned to evaluate emotional disorders during treatment by interferon (IFN) beta in relapsing remitting multiple sclerosis (RRMS) subjects. This is an open-label exploratory study with no change of therapeutic behavior but with standardized neuropsychologic follow-up.

Detailed description:
This study is planned to evaluate emotional disorders during treatment by IFN beta in RRMS subjects. This is an open-label, prospective, interventional, multicentric study with no change of therapeutic behavior but with standardized neuropsychologic follow-up. Subjects will undergo 13 evaluations (categorical and dimensional evaluations), 3 evaluations will be performed before the treatment (Baseline, Day 7 and 15) and 10 evaluations after the treatment (Month 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24).

Interventions: intervention 1: Interferon beta-1a
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01202279
Conditions: Acute Upper Respiratory Track Infection
Keywords: Acute Upper Respiratory Track Infection Who Seek Treatment
Sponsor: Reckitt Benckiser Inc.
Start date: 2009-10-01; Completion date: 2010-07-01
Enrollment: 1179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo

Detailed description:

Arms: arm 1: Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days arm 2: Placebo given bid with a full glass of water for 7 days
Interventions: intervention 1: Guaifenesin intervention 2: Placebo
Intervention descriptions: intervention 1: 1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days intervention 2: Placebo bid for 7 days

Protocol documents:
Clinical trial NCT01218399
Conditions: Asthma
Keywords: Asthma
Sponsor: Stanford University
Start date: 2009-09-01; Completion date: 2010-07-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with Stanford staff. We hypothesize that the budesonide/formoterol combination improves the efficacy of budesonide alone.

Detailed description:
The study was designed such that 30 participants would be consented/enrolled into the trial. The intervention would only be applied if the participant developed a viral illness that met eligibility criteria during the study period.

Only 10 of the 30 ppt. consented/enrolled developed a virus and were then treated according to study arm.

A more detailed description can be obtained by contacting Astra Zeneca

Arms: arm 1: Combination of budesonide and formoterol. Medications are given according to the package insert and manufacturer's instructions.

Participants that develop a viral upper respiratory illness which induces an asthma exacerbation.within the specified period following enrollment, are randomly assigned 1:1 to either study arm. 5 participants were randomly assigned to the Symbicort study arm. arm 2: Control of budesonide alone. Medication was given according to the package insert and manufacturer's instructions.

Participants that develop a viral upper respiratory illness which induces an asthma exacerbation.within the specified period following enrollment, are randomly assigned 1:1 to either study arm. 5 participants were randomly assigned to the Budesonide study arm.
Interventions: intervention 1: Symbicort
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01386970
Conditions: HIV
Keywords: Pharmacokinetics antiretroviral therapy nucleoside analogs mitochondrial toxicity clinical pharmacology cellular pharmacology pharmacogenetics
Sponsor: University of Colorado, Denver
Start date: 2005-05-01; Completion date: 2010-07-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the blood and blood cell concentrations of zidovudine and lamivudine in men versus women and in those with versus without HIV infection. Additionally, markers of side effects were correlated with blood levels of the drugs. The hypothesis was that women and those with HIV would have higher drug levels, as well as markers of side effects.

Detailed description:

Arms: arm 1: This group was used to compare intracellular ZDV- and 3TC-triphosphate concentrations to the HIV-infected group and in men versus women. arm 2: This group was started on ZDV-3TC based therapy. Intracellular ZDV- and 3TC-triphosphate concentrations were compared in men versus women and the HIV-negative group.
Interventions: intervention 1: zidovudine 300mg and lamivudine 150mg as Combivir
Intervention descriptions: intervention 1: twice daily for 12 days in the HIV-negative group and indefinitely for their care in the HIV-positive group

Protocol documents:
Clinical trial NCT01438060
Conditions: Dementia, Alzheimer Type
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2000-08-01; Completion date: 2010-07-01
Enrollment: 232 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to compare the efficacy of aripiprazole with placebo in patients with psychosis associated with Alzheimer's dementia.

Detailed description:
Open label Extension Phase: The 130-week Extension Phase was conducted to provide information regarding long-term safety and efficacy of aripiprazole in participants who were diagnosed at the onset of the Acute Phase with psychotic symptoms associated with dementia of the Alzheimer's type who responded to treatment in the 10-week Acute Phase of this study.

Treatment beyond 140 week: A country-specific amendment for France, allowed participants treated with aripiprazole who, according to the investigator's opinion, showed improvement at the Week 140 visit to continue treatment beyond 140 weeks. The termination was to be determined by clinical benefit to he participant.

Study design:

Acute Phase: Randomized, double-blind, placebo-controlled, flexible-dose, parallel-group study.

Extension Phase: Open label; flexible-dose.

Arms: arm 1: Double blind Acute Phase (Week 1 to Week 10), Open label Extension Phase (Week 11 to Week 140) arm 2: Double blind Acute Phase (Week 1 to Week 10)
Interventions: intervention 1: Aripiprazole (BMS-337039) intervention 2: Placebo
Intervention descriptions: intervention 1: Acute Phase: Oral, Tablets (1 and 5 mg), Week 1-2: 2 mg, Week 3-4: 2 - 5 mg, Week 5-6: 2 - 10 mg, Weeks 7-10: 2 - 15 mg, Once daily, 10 weeks

Extension Phase: Oral, Tablets (1 and 5 mg), Week 11: 2 mg, Weeks 12-13: 2 - 5 mg, Weeks 14-15: 2 - 10 mg, Weeks 16-140: 2 - 15 mg, Once daily, 130 weeks intervention 2: Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks

Protocol documents:
Clinical trial NCT01442064
Conditions: Macular Edema Retinal Vein Occlusion
Keywords: CNV Lucentis AMD Age-related macular degeneration RVO Macular edema secondary to retinal vein occlusion
Sponsor: Genentech, Inc.
Start date: 2008-07-01; Completion date: 2010-07-01
Enrollment: 608 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.

Detailed description:

Arms: arm 1: Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.
Interventions: intervention 1: Ranibizumab 0.5 mg
Intervention descriptions: intervention 1: Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year).

Protocol documents:
Clinical trial NCT01532128
Conditions: Parkinson Disease
Keywords: Parkinson Disease BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2009-11-01; Completion date: 2010-07-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline pharmacokinetics in healthy subjects.

Detailed description:
Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more

Arms: arm 1: Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg arm 2: Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg arm 3: Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg
Interventions: intervention 1: rasagiline intervention 2: BIA 9-1067
Intervention descriptions: intervention 1: 1 mg rasagiline (single-dose) intervention 2: 50 mg BIA 9-1067 (single-dose)

Protocol documents:
Clinical trial NCT01690052
Conditions: Dry Mouth
Keywords: dry mouth
Sponsor: University of Kentucky
Start date: 2009-01-01; Completion date: 2010-07-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects between the treatment for xerostomia with cevimeline and with pilocarpine.

Detailed description:
Pilocarpine is a cholinergic agonist with predominant muscarinic action.As such, it acts at muscarinic-cholinergic receptors found throughout the body and promotes fluid secretion. Due to this, one of the main side-effects of pilocarpine is an increased amount of sweating. Thus, not only are the salivary glands stimulated, but all of the body's exocrine glands' production is heightened. On the other hand, cevimeline is a drug with a high affinity for specific muscarinic receptors (M3) located on lachrymal and salivary gland epithelium. At least in theory, cevimeline will produce less side effects compared with pilocarpine because of the higher affinity for the muscarinic receptors located in the salivary glands. A limited number of human clinical trials in the efficacy of cevimeline and pilocarpine to increase the production of saliva and the side effects have been performed with no conclusive results.

The main purposes of this study were to determine the efficacy of cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and to compare the side-effects between these two medications.

Arms: arm 1: Cevimeline vs Pilocarpine arm 2: Pilocarpine vs. Cevimeline
Interventions: intervention 1: Cevimeline intervention 2: Pilocarpine
Intervention descriptions: intervention 1: Cevimlenine Vs Pilocarpine, cross over design. Two sequences were evaluated "cevimeline first, then pilocarpine" and "pilocarpine first, then cevimeline". Each sequence was evaluated for 4 weeks with one week "washout" period in between both sequences. 15 patients were randomly assigned to a specific sequence by a research pharmacist independent from the study authors. The patients received 30mg of cevimeline three times a day and pilocarpine 5mg three times a day. intervention 2: Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out

Protocol documents:
Clinical trial NCT01881087
Conditions: Disorder of Knee Anesthesia
Keywords: Knee Arthroscopy Levobupivacaine Spinal Anesthesia Motor Block
Sponsor: Fundacion Clinica Valle del Lili
Start date: 2006-06-01; Completion date: 2010-07-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate motor block probability throughout time and clinical profile when using three different doses of HLBP 0.75% (7.5, 9.37 and 11.25 mg) by a unilateral spinal block technique.

Detailed description:
Previous IRB approval and informed consent, 180 ASA I-II adults under ambulatory knee arthroscopy will be randomly allocated to receive unilateral spinal anesthesia with 7.5 (group Levo-7.5, n=59), 9.37(group Levo-9.37, n=61) and 11.25 (group Levo-11.25, n=60) mg of HLBP 0.75% using a 27-gauge Whitacre needle at a rate of 0.1 ml/ seg. and lateral decubitus position maintained for 5 min after injection.

An independent observer will evaluate motor (modified Bromage scale) and sensory (transcutaneal electrical stimulation at T10, L1, L3, and S1 dermal segments) levels and presence of adverse events immediately after return to supine, at the end of surgery and each 10 min from admission to PACU until home discharge conditions.

Trans-cutaneal electrical stimulation (TES) will be made with a PNS (Ministim® model MS- IV, Organon, Dublin, Irland) using 50-Hz tetanus stimuli for 5 seg. from 10 to 60 mA 3,4.

Arms: arm 1: Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 7.5 mg. Single Dose. arm 2: Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 9.37 mg. Single Dose. arm 3: Hyperbaric Levobupivacaine 0.75% Spinal Administration by a Whitacre Needle 27G. Dosage: 11.25 mg. Single Dose.
Interventions: intervention 1: Hyperbaric Levobupivacaine 0.75%
Intervention descriptions: intervention 1: Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.

Protocol documents:
Clinical trial NCT02010216
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-03-01; Completion date: 2010-07-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.

Detailed description:

Arms: arm 1: Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg by intravenous infusion every 4 weeks

Protocol documents:
Clinical trial NCT02169414
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) BIA 9-1067 Opicapone
Sponsor: Bial - Portela C S.A.
Start date: 2010-02-01; Completion date: 2010-07-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.

Detailed description:
A single-centre, randomized, double-blind, gender-balanced, placebo-controlled study in 4 groups of 18 healthy subjects each. This study consisted of a once-daily administration of BIA 9 1067 (5 mg, 15 mg or 50 mg) or placebo for 18 days. Twelve (12) hours after the BIA 9 1067 dose, a single-dose of levodopa/carbidopa 100/25 mg was administered on Day 11 and a single-dose of levodopa/benserazide 100/25 mg was administered on Day 18.

Arms: arm 1: 1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. arm 2: 3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. arm 3: 2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18. arm 4: 3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
Interventions: intervention 1: BIA 9-1067 5 mg intervention 2: BIA 9-1067 25 mg intervention 3: levodopa/carbidopa 100/25 intervention 4: Placebo intervention 5: levodopa/benserazide 100/25 mg
Intervention descriptions: intervention 1: OPC, Opicapone intervention 2: OPC, Opicapone intervention 3: immediate (standard) release levodopa/carbidopa 100/25 intervention 4: PLC, Placebo intervention 5: immediate (standard) release levodopa/benserazide

Protocol documents:
Clinical trial NCT01030965
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Bronchitis Anticholinergic Emphysema Long-acting muscarinic antagonist COPD
Sponsor: GlaxoSmithKline
Start date: 2009-12-15; Completion date: 2010-07-04
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

Arms: arm 1: 125mcg once-daily via novel dry powder inhaler arm 2: 250mcg once-daily via novel dry powder inhaler arm 3: 500mcg once-daily via novel dry powder inhaler arm 4: once-daily via novel dry powder inhaler
Interventions: intervention 1: GSK573719 125mcg intervention 2: GSK573719 250mcg intervention 3: GSK573719 500mcg intervention 4: Placebo
Intervention descriptions: intervention 1: 125mcg once-daily intervention 2: 250mcg once-daily intervention 3: 500mcg once-daily intervention 4: once-daily

Protocol documents:
Clinical trial NCT00988598
Conditions: Alzheimer's Disease
Keywords: phase 1 Alzheimer's disease donepezil
Sponsor: Pfizer
Start date: 2009-10-26; Completion date: 2010-07-05
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety of PF-04447943 when given in combination with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the absorption and distribution of both PF-04447943 and donepezil.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-04447943 intervention 2: Placebo
Intervention descriptions: intervention 1: 25 mg of PF-04447943 orally every 12 hours for 7 days intervention 2: 25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days

Protocol documents: