ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00668525
Conditions: Major Depressive Disorder
Keywords: Depression Major Depressive Disorder Escitalopram
Sponsor: Forest Laboratories
Start date: 2008-04-01; Completion date: 2009-02-01
Enrollment: 877 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.

Detailed description:

Arms: arm 1: Escitalopram low dose arm 2: Escitalopram high dose arm 3: Placebo
Interventions: intervention 1: Escitalopram intervention 2: Placebo intervention 3: Escitalopram
Intervention descriptions: intervention 1: Escitalopram low dose, oral administration, once daily dosing for 8 weeks. intervention 2: Placebo, oral administration, once daily dosing for 8 weeks intervention 3: Escitalopram high dose, oral administration, once daily dosing for 8 weeks

Protocol documents:
Clinical trial NCT00668746
Conditions: Periodontitis
Keywords: chronic periodontitis, antibiotic resistance
Sponsor: OraPharma
Start date: 2007-12-01; Completion date: 2009-02-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will look at the safety of using the study medicine for a long time. It will see if the germs get used to the medicine, making it not work as well, if it's used by people with gum disease for a long time.

Detailed description:
The objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline HCl microspheres, 1 mg in subjects with moderate-to-severe chronic periodontitis. This will be assessed through monitoring the total number and proportion of minocycline-resistant bacteria and the identity of minocycline-resistant species within a panel of 40 representative periodontal species in saliva and subgingival plaque.

Arms: arm 1: Minocycline HCl microspheres arm 2: No drug intervention
Interventions: intervention 1: Minocycline HCl microspheres
Intervention descriptions: intervention 1: At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.

Protocol documents:
Clinical trial NCT00676026
Conditions: Healthy
Keywords: menses women healthy controls Healthy females with regular menstrual cycles
Sponsor: University of Pennsylvania
Start date: 2005-05-01; Completion date: 2009-02-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this series of challenge studies is to examine the impact of menstrual cycle phase on cortical GABA response to administration of agents with either direct (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While the impact of these agents on cortical GABA levels in women with premenstrual dysphoric disorder (PMDD) is of interest, this study is designed primarily for those women without a psychiatric illness.

Detailed description:

Arms: arm 1: Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle. arm 2: Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle. arm 3: Fluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.
Interventions: intervention 1: Fluoxetine intervention 2: Zolpidem intervention 3: Progesterone
Intervention descriptions: intervention 1: Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant. intervention 2: Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant. intervention 3: Progesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle.

Protocol documents:
Clinical trial NCT00683657
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Start date: 2008-07-01; Completion date: 2009-02-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Saxagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 5mg, once daily, 4 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 4 weeks

Protocol documents:
Clinical trial NCT00688064
Conditions: Severe Acne Vulgaris
Keywords: Acne
Sponsor: Galderma R&D
Start date: 2008-08-01; Completion date: 2009-02-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Detailed description:
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

Arms: arm 1: Adapalene-BPO + Doxycyline arm 2: Vehicle + Doxycycline
Interventions: intervention 1: Adapalene BPO Gel associated with Doxycyline Hyclate intervention 2: Vehicle Gel associated with Doxycycline Hyclate
Intervention descriptions: intervention 1: Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks. intervention 2: Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.

Protocol documents:
Clinical trial NCT00696020
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2008-06-01; Completion date: 2009-02-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 micrograms tiotropium bromide solution for inhalation, delivered by the Respimat inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 2: BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 3: BI 1744 CL high dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 4: tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Interventions: intervention 1: BI 1744 CL/tiotropium bromide fixed dose combination intervention 2: tiotropium bromide intervention 3: Respimat® Inhaler
Intervention descriptions: intervention 1: BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation intervention 2: tiotropium bromide; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation intervention 3: None

Protocol documents:
Clinical trial NCT00698022
Conditions: Healthy
Keywords: healthy weight gain anti-psychotic risperidone mifepristone mitigation weight loss
Sponsor: Corcept Therapeutics
Start date: 2008-11-01; Completion date: 2009-02-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

Detailed description:
This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. The secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups.

Arms: arm 1: risperidone plus mifepristone daily for 28 days arm 2: risperidone plus mifepristone-matched placebo daily for 28 days arm 3: risperidone-matched placebo plus mifepristone daily for 28 days
Interventions: intervention 1: Risperidone intervention 2: Mifepristone intervention 3: Risperidone-matched placebo intervention 4: Mifepristone-matched placebo
Intervention descriptions: intervention 1: risperidone daily for 28 days intervention 2: mifepristone daily for 28 days intervention 3: risperidone-matched placebo daily for 28 days intervention 4: mifepristone-matched placebo daily for 28 days

Protocol documents:
Clinical trial NCT00707954
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes TA-7284
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-06-01; Completion date: 2009-02-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TA-7284 intervention 2: Placebo of TA-7284
Intervention descriptions: intervention 1: Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days) intervention 2: Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)

Protocol documents:
Clinical trial NCT00720499
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2008-07-01; Completion date: 2009-02-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation arm 2: BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Interventions: intervention 1: BI 1744 CL plus tiotropium bromide intervention 2: Respimat® Inhaler
Intervention descriptions: intervention 1: BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation intervention 2: None

Protocol documents:
Clinical trial NCT00730756
Conditions: Rhinitis, Allergic, Perennial
Keywords: Adolescents Irritant(non-allergic)rhinitis Adults GW685698 Air Pollution
Sponsor: GlaxoSmithKline
Start date: 2008-03-01; Completion date: 2009-02-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to compare the effects (effectiveness and safety)of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]) with a placebo nasal spray for the treatment of irritant (non-allergic) rhinitis.

Detailed description:

Arms: arm 1: Fluticasone Furoate Nasal Spray 110mcg intranasally once daily arm 2: Matching placebo nasal spray intranasally once daily
Interventions: intervention 1: Fluticasone Furoate Nasal Spray intervention 2: Placebo Nasal Spray
Intervention descriptions: intervention 1: Fluticasone furoate nasal spray 110mcg intranasally once daily for 4 weeks intervention 2: Matching placebo nasal spray intranasally once daily for 4 weeks

Protocol documents:
Clinical trial NCT00731120
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy
Sponsor: Takeda
Start date: 2008-06-01; Completion date: 2009-02-01
Enrollment: 457 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of 2.5 mg and 10 mg vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Detailed description:
Participants in this study will be randomly assigned to receive either 2.5 mg or 10 mg of vortioxetine or a placebo once daily for an eight week treatment period.

Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Total commitment time is up to 12 weeks.

Arms: arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 2.5 mg encapsulated tablets, orally, once daily for up to 8 weeks. arm 3: Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Vortioxetine placebo-matching capsules

Protocol documents:
Clinical trial NCT00731822
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease Novel Dry Powder Inhaler Chronic Obstructive Pulmonary Disease (COPD) GW685698/GW642444
Sponsor: GlaxoSmithKline
Start date: 2008-08-01; Completion date: 2009-02-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of a single dosage strength of GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Interventions: intervention 1: GW685698/GW642444
Intervention descriptions: intervention 1: GW685698/GW642444

Protocol documents:
Clinical trial NCT00742391
Conditions: Actinic Keratoses
Keywords: Peplin Actinic keratosis PEP005
Sponsor: Peplin
Start date: 2008-09-01; Completion date: 2009-02-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Detailed description:

Arms: arm 1: PEP005 (ingenol mebutate) Gel arm 2: Vehicle gel
Interventions: intervention 1: PEP005 (ingenol mebutate) Gel intervention 2: Vehicle gel
Intervention descriptions: intervention 1: two day treatment intervention 2: two day treatment

Protocol documents:
Clinical trial NCT00744848
Conditions: Hemorrhoids
Keywords: hemorrhoids
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2008-08-01; Completion date: 2009-02-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Detailed description:
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Arms: arm 1: 100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.

A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration. arm 2: 300 mg SKY0402 in a 40-mL injection volume.

A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration.
Interventions: intervention 1: Bupivacaine HCl intervention 2: SKY0402
Intervention descriptions: intervention 1: 100 mg Bupivacaine HCl intervention 2: Single administration 300 mg SKY0402 in a 40-mL injection volume

Protocol documents:
Clinical trial NCT00745290
Conditions: Postoperative Pain
Keywords: Total knee arthroplasty Pain Analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2008-08-01; Completion date: 2009-02-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.

Detailed description:
The primary objective is to demonstrate the superiority of SKY0402, compared with bupivacaine HC1, with respect to the extent and duration of the analgesic effect achieved by a single intraoperative administration of the study drug via local infiltration in subjects undergoing total knee arthroplasty (TKA).

The secondary objectives are to evaluate additional efficacy parameters and characterize the safety profile of SKY0402 in comparison with bupivacaine HCl.

Arms: arm 1: Single dose of 200 mg bupivacaine HCl administered intraoperatively via local infiltration arm 2: Single dose of 600 mg SKY0402 (study drug) administered intraoperatively via local infiltration
Interventions: intervention 1: Bupivacaine HCl intervention 2: SKY0402
Intervention descriptions: intervention 1: 200 mg bupivacaine HCl intervention 2: 600 mg SKY0402 (study drug).

Protocol documents:
Clinical trial NCT00758498
Conditions: Excessive Sleepiness
Sponsor: Cephalon
Start date: 2008-09-01; Completion date: 2009-02-01
Enrollment: 427 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.

Detailed description:

Arms: arm 1: armodafinil - dosage of 50 mg/day arm 2: armodafinil - dosage of 150 mg/day arm 3: matching placebo
Interventions: intervention 1: armodafinil intervention 2: armodafinil intervention 3: placebo
Intervention descriptions: intervention 1: 50 mg/day orally, once daily in the morning for 3 days intervention 2: 150 mg/day orally, once daily in the morning for 3 days intervention 3: placebo tablets, once daily in the morning for 3 days

Protocol documents:
Clinical trial NCT00758862
Conditions: Secondarily Infected Traumatic Lesions (SITL) Impetigo
Sponsor: LEO Pharma
Start date: 2008-12-01; Completion date: 2009-02-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A national, prospective single arm phase II study investigating the pharmacokinetics and safety of the 2% TD1414 cream when applied 3 times daily for 7 days to adult patients with impetigo or Secondarily Infected Traumatic Lesions (SITL). A total of 20 patients will be enrolled.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: 2% TD1414 Cream
Intervention descriptions: intervention 1: Application 3 times daily for 7 days

Protocol documents:
Clinical trial NCT00760578
Conditions: Type 2 Diabetes Mellitus
Sponsor: Metabolic Solutions Development Company
Start date: 2008-09-01; Completion date: 2009-02-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if MSDC-0160 is effective in the treatment of Type 2 diabetes.

Detailed description:

Arms: arm 1: Microcrystaline cellulose once daily arm 2: Pioglitazone 45 mg once daily arm 3: MSDC-0160 90 mg once daily arm 4: MSDC-0160 220 mg once daily
Interventions: intervention 1: Placebo intervention 2: Pioglitazone intervention 3: MSDC-0160 90 mg intervention 4: MSDC-0160 220 mg
Intervention descriptions: intervention 1: Once daily, oral intervention 2: Once daily, oral intervention 3: Once daily, oral intervention 4: Once daily, oral

Protocol documents:
Clinical trial NCT00780208
Conditions: Adult Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Attention Deficit Hyperactivity ADHD
Sponsor: Medical University of South Carolina
Start date: 2007-04-01; Completion date: 2009-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of Daytrana® in the treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused stimulants in the past. Daytrana® is a stimulant medication that has been approved by the Food and Drug Administration for the treatment of ADHD in children over the age of 6 years old.

Detailed description:
Methylphenidate and amphetamines are considered to be the first line of treatment for ADHD in children (Biederman et al, 1997). Although treating children and adolescents with stimulants does not appear to increase the risk of substance use disorders (Wilens et al, 2003), little is known about the abuse of prescription stimulants in adults with ADHD. A review of the literature on the abuse potential of methylphenidate in animals and humans found that methylphenidate produced reinforcing, discriminative-stimulus, and subjective effects similar to amphetamines or cocaine (Kollins et al, 2001). Although the abuse rates of methylphenidate and other stimulant medications used for the treatment of ADHD have not been empirically established, significant concern exists so that regulatory mandates are enforced to control distribution, and some physicians may be reluctant to use stimulants in patients with drug abuse histories. The introduction of a methylphenidate patch is an important advancement, as the patch formulation should increase compliance while minimizing abuse potential, making it an attractive treatment option in the large population of individuals who have a history of previous drug misuse. The primary aim of this study is to assess the efficacy of the methylphenidate patch in adult individuals with ADHD who have abused stimulants in the past. It is hypothesized that the methylphenidate patch will be efficacious in reducing ADHD symptoms in this population.

Arms: arm 1: Methylphenidate patch
Interventions: intervention 1: Daytrana (methylphenidate patch)
Intervention descriptions: intervention 1: Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.

Protocol documents: