ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00833560
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Untreated multiple myeloma Bortezomib VELCADE Cyclophosphamide Dexamethasone Chemotherapy Remission therapy Induction therapy Stem Cell Transplantation
Sponsor: Janssen-Cilag G.m.b.H
Start date: 2006-03-01; Completion date: 2009-06-01
Enrollment: 401 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.

Detailed description:
This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome of the study), multi-centre, and non-randomized (participants are assigned to different treatment groups by the investigator) study. The study will be conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be administered. Part 2 will include a screening period of a maximum of 14 days followed by chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, electrocardiogram, and clinical laboratory tests which will be monitored throughout the study.

Arms: arm 1: Part 1 will be the dose titration part for cyclophosphamide. Participants will receive cyclophosphamide, bortezomib, and dexamethasone for 3 cycles. In Part 2, participants will receive cyclophosphamide (dose determined in Part 1) with pre-defined dose of bortezomib and dexamethasone for 3 cycles.
Interventions: intervention 1: Cyclophosphamide intervention 2: Bortezomib intervention 3: Dexamethasone
Intervention descriptions: intervention 1: In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles. intervention 2: Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2). intervention 3: Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2).

Protocol documents:
Clinical trial NCT00833638
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Start date: 2009-02-01; Completion date: 2009-06-01
Enrollment: 372 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.

Detailed description:

Arms: arm 1: No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days. arm 2: No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. arm 3: No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
Interventions: intervention 1: Placebo intervention 2: Tadalafil
Intervention descriptions: intervention 1: One tablet orally daily intervention 2: Orally once daily

Protocol documents:
Clinical trial NCT00842361
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2009-01-01; Completion date: 2009-06-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: biphasic insulin aspart 30
Intervention descriptions: intervention 1: The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner. intervention 2: The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.

Protocol documents:
Clinical trial NCT00848484
Conditions: Schizophrenia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-01; Completion date: 2009-06-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia.

Detailed description:

Arms: arm 1: MK5757 arm 2: Placebo
Interventions: intervention 1: MK5757 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days intervention 2: This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days.

Protocol documents:
Clinical trial NCT00852137
Conditions: Actinic Keratosis
Keywords: Peplin PEP005 Actinic Keratosis
Sponsor: Peplin
Start date: 2009-03-01; Completion date: 2009-06-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate) Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in patients with actinic keratoses

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PEP005 (ingenol mebutate) Gel, 0.05% intervention 2: Vehicle Gel
Intervention descriptions: intervention 1: PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days intervention 2: Vehicle Gel once daily for 2 consecutive days

Protocol documents:
Clinical trial NCT00855738
Conditions: Focal Epilepsy
Keywords: epilepsy antiepileptic biotherapy
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-05-01; Completion date: 2009-06-01
Enrollment: 111 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination therapy (bitherapy) in patients with focal epilepsy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
Intervention descriptions: intervention 1: * Gabapentin: up to 3.600 mg/d
* Lamotrigine: up to 400 mg/d
* Levetiracetam: up to 3.000 mg/d
* Pregabalin: up to 600 mg/d
* Oxcarbazepine: up to 2.400 mg/d
* Tiagabine: up to 30 mg/d
* Topiramate: up to 400 mg/d
* Zonisamide: up to 500 mg/d

Protocol documents:
Clinical trial NCT00867035
Conditions: Halitosis
Sponsor: University of California, San Francisco
Start date: 2008-03-01; Completion date: 2009-06-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Medical center personnel were screened organoleptically for bad breath by 2 investigators using Rosenberg scale 0-5, and measurement of breath sample in portable gas chromatograph. With a threshold score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S), subjects invited to enter clinical trial of the mechanical effect of daily tongue scraping with the adjunctive use of 0.12% chlorhexidine gluconate mouthwash or 0.1% stabilized chlorine dioxide mouthwash. Subjects randomly assigned in double-blind trial for one week. The null hypothesis is there will be no difference between the two rinses as adjuncts to tongue scraping.

Detailed description:
Subjects in trial had oral and periodontal exam and scored the Ramfjord teeth(#3, 9, 12, 19, 25, 28) for Plaque Index(PlI), Gingival Index(GI), probing depth (PD), recession. A tongue coating index is scored and sample of coating on dorsum taken for culture of total viable count and percentage of black sulfide-producing colonies on anaerobe agar with lead acetate added. Subjects given hygiene instruction and instruction on use of scraper, then rinse with 20ml assigned mouthwash 30sec. Breath assessed by organoleptic means and mouth air sample concentration of hydrogen sulfide, methyl mercaptan in portable gas chromatograph at 0, 1, 2, and 4 hours. Subjects use scraper and mouthwash twice daily for one week and return for final exam.

Arms: arm 1: The intervention was accomplished by subject after instructions from investigator: twice a day a tongue scraper was used with 4 or more strokes, followed by 20ml of 0.12% chlorhexidine gluconate mouthwash used for 30 sec, for one week. arm 2: The intervention was accomplished by subject after instructions by investigator: twice a day the scraper was used for 4 strokes then 20ml 0.1% stabilized chlor8ine dioxide rinse for 30sec, for one week.
Interventions: intervention 1: Chlorine dioxide and scraper intervention 2: Chlorhexidine gluconate and scraper
Intervention descriptions: intervention 1: 20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day intervention 2: The intervention was accomplished by subject after instructions by investigator: twice a day the scraper was used for 4 strokes then 20ml 0.12% chlorhexidine gluconate rinse for 30sec, for one week.

Protocol documents:
Clinical trial NCT00869167
Conditions: Insomnia Asthma
Sponsor: Northwestern University
Start date: 2008-03-01; Completion date: 2009-06-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.

Detailed description:
Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ramelteon
Intervention descriptions: intervention 1: melatonin agonist

Protocol documents:
Clinical trial NCT00869791
Conditions: Parkinson's Disease
Keywords: Parkinson's
Sponsor: Impax Laboratories, LLC
Start date: 2008-11-01; Completion date: 2009-06-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.

Detailed description:
This was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in LD-experienced subjects with Parkinson's disease (PD). Subjects received 7 days of one treatment (IPX066 or IR CD-LD) followed by an approximate 7-day washout period followed by another 7 days of the other treatment (IR CD-LD or IPX066). During the approximate 7-day washout period, subjects took their prestudy CD-LD regimen. Pharmacokinetic and efficacy/pharmacodynamic measurements were done on Days 1 and 8. Safety measures (electrocardiograms \[ECGs\], clinical laboratory tests, vital signs, adverse events \[AEs\], and concomitant medications) were evaluated over the course of the study.

Arms: arm 1: Treatment Period 1:

IPX066 - 7 days; Washout Period - 7 days;

Treatment Period 2:

IR CD-LD- 7 days arm 2: Treatment Period 1:

IR CD-LD - 7 days; Washout period - 7 days;

Treatment Period 2:

IPX066- 7 days
Interventions: intervention 1: IPX066 intervention 2: IR CD-LD
Intervention descriptions: intervention 1: experimental drug product: extended-release carbidopa-levodopa capsules intervention 2: active comparator: immediate-release carbidopa-levodopa capsules

Protocol documents:
Clinical trial NCT00874237
Conditions: Thorough QT/QTc Study
Keywords: Staccato loxapine QT/QTc healthy volunteers Thorough QT/QTc study ADASUVE inhaled loxapine
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2009-04-01; Completion date: 2009-06-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.

Detailed description:
Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers.

Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.

Arms: arm 1: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 2: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 3: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 4: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 5: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 6: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
Interventions: intervention 1: Inhaled loxapine intervention 2: Inhaled placebo intervention 3: Oral moxifloxacin intervention 4: Oral placebo
Intervention descriptions: intervention 1: Inhaled Staccato Loxapine 10 mg single dose intervention 2: Inhaled Staccato placebo single dose intervention 3: Oral moxifloxacin 400 mg intervention 4: Oral placebo similar in appearance to moxifloxacin 400 mg

Protocol documents:
Clinical trial NCT00887484
Conditions: Acne Vulgaris
Keywords: Acne Acne Vulgaris
Sponsor: Stiefel, a GSK Company
Start date: 2009-02-01; Completion date: 2009-06-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.

Detailed description:
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.

Arms: arm 1: Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. arm 2: Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening.
Interventions: intervention 1: BENZOYL PEROXIDE/ CLINDAMYCIN intervention 2: BENZOYL PEROXIDE/ ADAPALENE
Intervention descriptions: intervention 1: Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks. intervention 2: Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks.

Protocol documents:
Clinical trial NCT00903448
Conditions: Healthy
Keywords: Normal Healthy Subject Population
Sponsor: Procter and Gamble
Start date: 2009-04-01; Completion date: 2009-06-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.

Detailed description:

Arms: arm 1: Prilosec OTC arm 2: Prevacid
Interventions: intervention 1: Prilosec OTC (omeprazole-magnesium) intervention 2: Prevacid
Intervention descriptions: intervention 1: Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast intervention 2: Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast

Protocol documents:
Clinical trial NCT00932373
Conditions: Metastatic Breast Cancer
Keywords: HER2-positive breast cancer MBC Trastuzumab emtansine Herceptin T-DM1
Sponsor: Genentech, Inc.
Start date: 2006-04-01; Completion date: 2009-06-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: trastuzumab-MCC-DM1
Intervention descriptions: intervention 1: Intravenous escalating dose

Protocol documents:
Clinical trial NCT00938704
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2009-06-01; Completion date: 2009-06-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.

Detailed description:

Arms: arm 1: carboxymethylcellulose 0.5%, glycerin 0.9% arm 2: sodium hyaluronate 0.18%
Interventions: intervention 1: carboxymethylcellulose 0.5% +glycerin 0.9% intervention 2: sodium hyaluronate 0.18%
Intervention descriptions: intervention 1: To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container. intervention 2: To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.

Protocol documents:
Clinical trial NCT01084603
Conditions: Tobacco Dependence
Keywords: Smoking Cessation Nicotine pharmacokinetics
Sponsor: McNeil AB
Start date: 2009-03-01; Completion date: 2009-06-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.

Detailed description:
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Arms: arm 1: One oral administration of 1 mg nicotine arm 2: Two oral administrations of 1 mg nicotine arm 3: Four oral administrations of 1 mg nicotine arm 4: One 4 mg marketed nicotine lozenge arm 5: One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
Interventions: intervention 1: Oral Nicotine intervention 2: NiQuitinTM Nicotine Lozenge intervention 3: Nicorette® Nicotine Gum
Intervention descriptions: intervention 1: A new l mg oral nicotine product intervention 2: A marketed 4 mg Nicotine lozenge intervention 3: A marketed 4 mg Nicotine Gum

Protocol documents:
Clinical trial NCT01103440
Conditions: Stable Angina
Keywords: Major Adverse Cardiovascular Event MACE Death MI CK MB greater 3x Normal Urgent Revascularization Stent Thrombosis Bleeding
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2007-04-01; Completion date: 2009-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention (PCI).

Detailed description:
This is the first US based randomized double blinded prospective study using triple antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients undergoing elective PCI through femoral access. The primary outcome of this study is an elevation of cardiac enzymes within 24 hours after the PCI with a secondary outcome of a composite of major adverse cardiac events of death, MI, stent thrombosis and urgent revascularization and bleeding up to 30 days.

Arms: arm 1: Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure arm 2: Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally
Interventions: intervention 1: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel intervention 2: Antiplatelet Therapy (ASA, Clopidogrel)
Intervention descriptions: intervention 1: IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally intervention 2: Standard antiplatelet PCI treatment

Protocol documents:
Clinical trial NCT01136226
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Sponsor: Chesapeake Urology Research Associates
Start date: 2003-10-01; Completion date: 2009-06-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.

Detailed description:
This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).

Arms: arm 1: Eligard (TM) administered 22.5mg
Interventions: intervention 1: Eligard (TM)
Intervention descriptions: intervention 1: Eligard (TM) 22.5 mg administered at baseline and Month 3

Protocol documents: