ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00987558
Conditions: Epilepsy
Keywords: Eslicarbazepine acetate simvastatin
Sponsor: Bial - Portela C S.A.
Start date: 2009-06-01; Completion date: 2009-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.

Detailed description:
This was a single centre, two-way crossover, randomised, open-label study in 24 healthy volunteers. The volunteers will receive an oral single-dose of simvastatin 80 mg on two occasions - once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days -, separated by a washout period of 3 weeks or more

Arms: arm 1: Simvastatin 80mg treatment period followed by Simvastatin 80 mg + eslicarbazepine acetate 800 mg treatment period arm 2: Simvastatin 80mg + eslicarbazepine acetate 800 mg treatment period followed by Simvastatin 80 mg treatment period
Interventions: intervention 1: Eslicarbazepine acetate intervention 2: Simvastatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01001975
Conditions: Sun Protection
Keywords: Sunscreens
Sponsor: Bayer
Start date: 2009-07-01; Completion date: 2009-08-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensulizole.

Detailed description:

Arms: arm 1: Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet B radiation \[UVB\] and UVA). arm 2: Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
Interventions: intervention 1: Sunscreen Test Code: V53-028 intervention 2: Sunscreen Test Code: V53-030 intervention 3: Standard SPF 4 Sunscreen
Intervention descriptions: intervention 1: Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole intervention 2: Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone intervention 3: 8% Homosalate Standard SPF 4 Sunscreen

Protocol documents:
Clinical trial NCT01004744
Conditions: Invasive Breast Cancer
Keywords: Postmenopausal women ER+ Estrogen positive PR+ Progesterone positive
Sponsor: Columbia University
Start date: 2007-07-01; Completion date: 2009-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the feasibility of a short term administration of a targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non invasive breast cancer during the interval between their breast biopsy and surgery. Anastrozole is a form of hormonal therapy which is part of the standard treatment for hormone sensitive breast cancer in postmenopausal women. This clinical model is being used to evaluate the biologic effects of this drug on a specific molecular pathway called the PI3K/AKT signaling pathway.

Detailed description:
Several clinical models are being explored for use in the phase I/II evaluation of targeted therapies for breast cancer. Biological markers can be measured in early stage invasive cancers in a presurgical model involving a short term intervention. In this model, women with newly diagnosed early invasive breast cancer receive a study drug during the interval between diagnostic breast biopsy and surgical resection. Tumor tissue obtained from the biopsy and surgical specimens are used to measure pre and post treatment molecular markers, respectively. The main advantages of this model include the ability to obtain direct information on molecular response in tumor tissue and elucidate drug mechanisms of action, the large patient population to draw from with early stage breast cancer, and the lack of unnecessary invasive procedures.

We plan to conduct a pilot study of 10 postmenopausal women with newly diagnosed estrogen receptor (ER) positive invasive or non invasive breast cancer who will receive oral anastrozole 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. Patients will be identified by the breast surgeon or mammographer performing the breast biopsy. Patients with histologically confirmed ER+ invasive or non invasive breast cancer will be recruited by the medical oncologist and will start anastrozole two weeks prior to their scheduled surgery. The primary objective of this study is to demonstrate the feasibility of this presurgical model for evaluating targeted therapies for breast cancer. Secondary endpoints include changes in tissue levels of the proliferation marker Ki67 and proteins involved in PI3K/AKT signaling.

Arms: arm 1: 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery.
Interventions: intervention 1: Anastrozole
Intervention descriptions: intervention 1: 1mg PO daily for two weeks prior to scheduled surgery

Protocol documents:
Clinical trial NCT01012622
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Hyperactivity Disorder Methylphenidate Hydrochloride
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2008-09-01; Completion date: 2009-08-01
Enrollment: 142 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Osmotic Release Oral System (OROS) methylphenidate in participants with Attention Deficit Hyperactivity Disorder (ADHD).

Detailed description:
This is an open-label (all people involved know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), prospective study (study following participants forward in time) to evaluate the efficacy and safety of OROS methylphenidate in participants with ADHD (behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity). The study duration will be of 12 weeks per participant, which is divided into 2 parts Screening (within 14 days before study commences on Day -1) and treatment (8 weeks and will include titration period \[from the initiation of the study treatment to determination of the individual's maintenance dose\] and maintenance period \[at least 4 weeks after determination of maintenance dose\]). Participants will receive initial dose depending on their body weight. OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability. Efficacy will be evaluated by Korean Version, ADHD Rating Scale (K-ARS) total score and Clinical Global Impression)-Severity / Impression rating scale CGI-S/I. Participants safety will be monitored throughout the trial.

Arms: arm 1: None
Interventions: intervention 1: Osmotic Release Oral System (OROS) Methylphenidate Hydrochloride
Intervention descriptions: intervention 1: OROS methylphenidate hydrochloride (HCL) will be given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose will be increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.

Protocol documents:
Clinical trial NCT01018095
Conditions: Trichomonas Infections HIV Infections
Sponsor: Tulane University Health Sciences Center
Start date: 2005-05-01; Completion date: 2009-08-01
Enrollment: 270 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the 2 gram single dose of metronidazole is as effective as the 7 day 500 mg BID dose for treatment of Trichomonas vaginalis (TV) among HIV-infected women.

Detailed description:
This is a Phase IV equivalency trial as both doses of metronidazole are listed in the the Centers for Disease Control and Prevention Treatment Guidelines for the treatment of T vaginalis.

Arms: arm 1: Metronidazole 2 gm single dose arm 2: Metronidazole 500 mg dose x 7 days
Interventions: intervention 1: Metronidazole
Intervention descriptions: intervention 1: 2 gm single dose versus 7 day 500 mg BID dose

Protocol documents:
Clinical trial NCT01053247
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Sponsor: Fougera Pharmaceuticals Inc.
Start date: 2008-01-01; Completion date: 2009-08-01
Enrollment: 793 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis.

Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.

Detailed description:

Arms: arm 1: Test product that contains the active pharmaceutical ingredient arm 2: Reference product that contains active pharmaceutical ingredient arm 3: Placebo that contains no active pharmaceutical ingredient
Interventions: intervention 1: 0416 intervention 2: Vehicle of 0416 test product intervention 3: tacrolimus ointment 0.1%
Intervention descriptions: intervention 1: Topical 0416 test product applied twice daily for 2 weeks intervention 2: Vehicle of 0416 test product applied twice daily for 2 weeks intervention 3: Reference Product for 0416 test product. Apply twice daily for 2 weeks.

Protocol documents:
Clinical trial NCT01069120
Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Sponsor: Repros Therapeutics Inc.
Start date: 2009-04-01; Completion date: 2009-08-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and efficacy study of 25 and 50 mg doses of Proellex

Detailed description:
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Arms: arm 1: 2, 25 mg capsules arm 2: 1, 25 mg capsule
Interventions: intervention 1: Proellex intervention 2: Proellex
Intervention descriptions: intervention 1: 2, 25 mg capsules once per day intervention 2: 1, 25 mg capsule once per day

Protocol documents:
Clinical trial NCT01139450
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Sponsor: Fougera Pharmaceuticals Inc.
Start date: 2008-01-01; Completion date: 2009-08-01
Enrollment: 899 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis.

Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 4 weeks.

Detailed description:

Arms: arm 1: Test product that contains the active pharmaceutical ingredient arm 2: Reference product that contains the active pharmaceutical ingredient arm 3: Placebo that contains no active pharmaceutical ingredient
Interventions: intervention 1: 0417 intervention 2: Vehicle of 0417 test product intervention 3: Tacrolimus Ointment 0.03%
Intervention descriptions: intervention 1: Topical 0417 test product applied twice daily for 4 weeks intervention 2: Vehicle of 0417 test product applied twice daily for 4 weeks intervention 3: Reference product for 0417 test product. Apply twice daily for 4 weeks

Protocol documents:
Clinical trial NCT01318122
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy
Sponsor: Takeda
Start date: 2008-05-01; Completion date: 2009-08-01
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study.

Detailed description:
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Alogliptin and pioglitazone intervention 2: Alogliptin and pioglitazone
Intervention descriptions: intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

Protocol documents:
Clinical trial NCT02799069
Conditions: Actinic Keratosis
Sponsor: Biofrontera Bioscience GmbH
Start date: 2008-04-01; Completion date: 2009-08-01
Enrollment: 571 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.

Detailed description:
This was a randomized, observer-blind, multinational, comparator and placebo-controlled parallel group, (3:3:1 ratio) study to compare the efficacy and safety of BF-200 ALA with the comparator Metvix® (methyl-\[5-amino-4-oxopentanoate\]) and placebo, for the treatment of AK with PDT.

Arms: arm 1: Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. arm 2: Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin. arm 3: Topical application of matched Placebo to BF-200 ALA gel (without containing active ingredient) ). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.
Interventions: intervention 1: BF-200 ALA intervention 2: MAL Cream intervention 3: Vehicle
Intervention descriptions: intervention 1: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. intervention 2: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source. intervention 3: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.

Protocol documents:
Clinical trial NCT00913627
Conditions: Pain
Keywords: Extended-release ibuprofen
Sponsor: Pfizer
Start date: 2009-05-07; Completion date: 2009-08-05
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, \[roller compaction\] and \[wet granulation\] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.

Detailed description:

Arms: arm 1: 1 x 600 mg ibuprofen IR/ER-roller compaction caplet arm 2: 1 x 600 mg ibuprofen IR/ER-Wet granulation caplet arm 3: 1x 220 mg naproxen sodium (Aleve caplet) arm 4: 1 x placebo caplet
Interventions: intervention 1: ibuprofen intervention 2: ibuprofen intervention 3: naproxen intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00817414
Conditions: Hypertension
Keywords: Blood Pressure Hypertension Cortisol
Sponsor: Novartis
Start date: 2009-01-14; Completion date: 2009-08-12
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study determined the maximum dose of LCI6999 with respect to effect on the ACTH-stimulated cortisol response in participants with hypertension.

Detailed description:

Arms: arm 1: Participants received LCI699 0.5 mg, capsules, orally, once daily (QD), with or without food for up to 6 weeks. arm 2: Participants received LCI699 1.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. arm 3: Participants received LCI699 1.0 mg, capsules, orally, twice daily (BID), with or without food for up to 6 weeks. arm 4: Participants received LCI699 2.0 mg, capsules, orally, QD, with or without food for up to 6 weeks. arm 5: Participants received LCI699-matching placebo, capsules, orally, QD or BID, with or without food for up to 6 weeks.
Interventions: intervention 1: LCI699-matching placebo intervention 2: LCI699
Intervention descriptions: intervention 1: LCI699-matching placebo oral capsules intervention 2: LCI699 oral capsules

Protocol documents:
Clinical trial NCT00554606
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Anti-interleukin-1 beta ACZ885
Sponsor: Novartis
Start date: 2007-10-11; Completion date: 2009-08-13
Enrollment: 115 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.

Detailed description:

Arms: arm 1: Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.
Interventions: intervention 1: Canakinumab
Intervention descriptions: intervention 1: Canakinumab

Protocol documents:
Clinical trial NCT00920426
Conditions: Infection, Human Immunodeficiency Virus
Keywords: HIV naive Phase II integrase inhibitor GSK1265744 newly diagnosed pharmacokinetics AIDS integrase HIV Infections Treatment naive
Sponsor: ViiV Healthcare
Start date: 2009-06-09; Completion date: 2009-08-13
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized, double-blinded study is to test the safety of GSK1265744 and how well it works on reducing the amount of HIV in the blood. It will also look at how people react to and how a human body uses GSK1265744. This study will compare the effects of GSK1265744 and placebo.

The study will consist of 1 or 2 parts to look at doses of GSK1265744. About 8 people will take part in Part 1 of the study receiving dose A. If additional dosing information is needed after Part 1, about 6 people will take part in Part 2 of the study receiving dose B.

Detailed description:

Arms: arm 1: GSK1265744 30 mg arm 2: Placebo to match GSK1265744 arm 3: GSK1265744 5 mg
Interventions: intervention 1: GSK1265744 30mg intervention 2: Placebo intervention 3: GSK1265744 5mg
Intervention descriptions: intervention 1: GSK1265744 30 mg intervention 2: Placebo to match GSK1265744 intervention 3: GSK1265744 5mg

Protocol documents:
Clinical trial NCT00972504
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Proof of concept
Sponsor: GlaxoSmithKline
Start date: 2009-06-01; Completion date: 2009-08-14
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: 10mg oral dose arm 2: 1000mcg nasal spray solution arm 3: 10mg cetirizine as active comparator arm 4: placebo
Interventions: intervention 1: GSK835726 10mg intervention 2: GSK1004723 1000mcg intervention 3: Cetirizine 10mg intervention 4: placebo
Intervention descriptions: intervention 1: GSK835726 10mg tablet intervention 2: GSK1004723 1000mcg nasal spray solution intervention 3: Cetirizine 10mg active comparator intervention 4: placebo to match actives

Protocol documents:
Clinical trial NCT00446849
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis compliance mesalamine clinical study clinical trial clinical research maintenance long term uc study uc trial uc research open label once a day once daily daily dosing simple oral
Sponsor: Shire
Start date: 2007-05-01; Completion date: 2009-08-17
Enrollment: 290 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MMX Mesalamine
Intervention descriptions: intervention 1: MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).

Protocol documents:
Clinical trial NCT00610675
Conditions: Insomnia
Keywords: Fifty two weeks Open label extension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-07; Completion date: 2009-08-17
Enrollment: 346 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.

Detailed description:

Arms: arm 1: One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks
Interventions: intervention 1: Org 50081
Intervention descriptions: intervention 1: One tablet daily

Protocol documents: