ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00944697
Conditions: Moderate to Severe Pain Due to Diabetic Polyneuropathy
Sponsor: Mundipharma Research GmbH & Co KG
Start date: 2009-07-01; Completion date: 2010-04-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.

Detailed description:
Study OXN2502 is a pilot, exploratory, randomised, placebo-controlled, double-blind, single-dummy, parallel group study to assess efficacy and safety of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from moderate to severe pain due to diabetic polyneuropathy.

Arms: arm 1: A placebo tablet to match the active reference treatment arm 2: Oxycodone Naloxone tablets
Interventions: intervention 1: Oxycodone Naloxone intervention 2: Placebo tablets
Intervention descriptions: intervention 1: Oxycodone Naloxone tablets intervention 2: Placebo Oxycodone Naloxone tablets

Protocol documents:
Clinical trial NCT00954122
Conditions: Schizophrenia
Keywords: Acute schizophrenia
Sponsor: AstraZeneca
Start date: 2009-09-01; Completion date: 2010-04-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.

Detailed description:

Arms: arm 1: Quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards.
Interventions: intervention 1: Quetiapine XR (Seroquel XR)
Intervention descriptions: intervention 1: Tablet, oral, once daily

Protocol documents:
Clinical trial NCT00958724
Conditions: Advanced Malignant Solid Tumors
Keywords: HKI-272 Vinorelbine Combination Solid Tumor Neratinib Nerlynx PB-272
Sponsor: Puma Biotechnology, Inc.
Start date: 2009-07-01; Completion date: 2010-04-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this study are to evaluate the safety and tolerability of neratinib in combination with vinorelbine at the maximum tolerated dose (MTD) determined in a previous study, or to determine a lower MTD of the two drugs, as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors in Japanese patients.

Detailed description:

Arms: arm 1: Neratinib: 240 mg administered daily by mouth continuously, Vinorelbine: 25 mg/m\^2 administered IV on Day 1 and 8 of 21 day cycle
Interventions: intervention 1: Neratinib intervention 2: Vinorelbine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00962039
Conditions: Abdominal Pain Anxiety
Keywords: Abdominal Pain Anxiety
Sponsor: John V. Campo, M.D.
Start date: 2004-07-01; Completion date: 2010-04-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine whether citalopram is a useful, well-tolerated, and safe treatment for children and adolescents ages 7 to 18 years with functional abdominal pain. The study hypothesis is that citalopram will be better than placebo in producing clinical improvement and reductions in abdominal pain. It is also hypothesized that citalopram and placebo will not differ in terms of safety and tolerability.

Detailed description:
This study aims to determine the relative efficacy, tolerability, and safety of the citalopram in the treatment of pediatric functional recurrent abdominal pain (FAP) in children and adolescents ages 7 to 18 years, inclusive. The goal is to recruit and randomize 100 subjects to citalopram or placebo. Secondary aims include to determine if citalopram is superior to placebo in reducing comorbid anxiety and depressive symptoms in children and adolescents with FAP, to explore potential mediators (i.e., anxiety, depression) and moderators (e.g., age, gender, referral from primary or specialty care) of treatment response, and to explore the durability and tolerability of citalopram treatment 18 weeks following completion of the double-blind treatment phase with the goal of generating data useful to the development of future studies. The study is novel in conducting recruitment, assessment, and treatment in traditional medical settings. Limited exclusion criteria and the delivery of study assessments and interventions within routine practice settings provide for considerably greater external validity than the typical efficacy study.

Study hypotheses:

1. Citalopram will be superior to placebo in producing clinical improvement and reductions in abdominal pain.
2. Citalopram and placebo will not differ in tolerability or safety.

Arms: arm 1: Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2). arm 2: Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.
Interventions: intervention 1: Citalopram intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects. intervention 2: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.

Protocol documents:
Clinical trial NCT00994461
Conditions: Healthy Volunteers
Keywords: Endoscopy
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-11-01; Completion date: 2010-04-01
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Celecoxib intervention 2: Loxoprofen intervention 3: Placebo
Intervention descriptions: intervention 1: Celecoxib 100mg tablet twice a day with meal for 2 weeks intervention 2: Loxoprofen 60mg tablet three times a day with meal for 2 weeks intervention 3: Placebo tablet three times a day with meal for 2 weeks

Protocol documents:
Clinical trial NCT01001195
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2009-11-01; Completion date: 2010-04-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).

Detailed description:

Arms: arm 1: One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. arm 2: One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. arm 3: One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. arm 4: One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
Interventions: intervention 1: AGN-210669 ophthalmic solution, 0.1% intervention 2: AGN-210669 ophthalmic solution, 0.075% intervention 3: AGN-210669 ophthalmic solution, 0.05% intervention 4: bimatoprost ophthalmic solution 0.03%
Intervention descriptions: intervention 1: One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. intervention 2: One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. intervention 3: One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. intervention 4: One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Protocol documents:
Clinical trial NCT01001403
Conditions: Liver Transplantation Postreperfusion Syndrome
Sponsor: Seoul National University Hospital
Start date: 2009-03-01; Completion date: 2010-04-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.

Detailed description:

Arms: arm 1: The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft. arm 2: The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.
Interventions: intervention 1: Nafamostat intervention 2: Normal saline
Intervention descriptions: intervention 1: 0.2 mg/kg as bolus 1 minute before reperfusion intervention 2: 10 ml of normal saline

Protocol documents:
Clinical trial NCT01004042
Conditions: Depression Quality of Life
Keywords: Depression Botulinum toxin Glabella Quality of life Self-steem
Sponsor: Brazilan Center for Studies in Dermatology
Start date: 2009-10-01; Completion date: 2010-04-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the alterations in quality of life and self-esteem after BOTOX® injections in the glabella in depressed and non-depressed patients.

The secondary objective of this study are:

* to assess wrinkles improvement
* to evaluate depressive symptoms using Beck Depression Inventory before and after Botox® injections.
* to elucidate that depression is not a contraindication for botulinum toxin injections.

Detailed description:
The study consists of two groups: one with diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0) and other without diagnosis of depression.

Subjects with depression will be part of group 1. They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Subjects with no diagnosis of depression will be part of group 2. Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®, Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Four visits will be scheduled. Visit 0 (baseline), Visit 1 (intervention), visit 2 (4 weeks), visit 3 (8 weeks) visit 4 (12 weeks).

The scales for the assessment of depressive symptoms, Beck Depression Inventory (BDI), will be applied at visits 1,2,3,4; WHOQOL BREF will be applied at baseline visit and 4.

Rosenberg Self-Esteem Scale will be applied in all visits. Photographs will be taken as well as the dermatological evaluation of the wrinkles and folds will be assessed using a 4-points validated Severity Wrinkles Scale, and psychiatric evaluation as well, in both groups.

Arms: arm 1: Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist. arm 2: Subjects with no diagnosis of depression
Interventions: intervention 1: Botulinum Toxin Type A
Intervention descriptions: intervention 1: Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Protocol documents:
Clinical trial NCT01010282
Conditions: Dry Eye Syndrome
Sponsor: Allergan
Start date: 2009-11-01; Completion date: 2010-04-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.

Detailed description:

Arms: arm 1: Glycerin and Polysorbate 80 based artificial tear arm 2: Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear arm 3: Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
Interventions: intervention 1: Glycerin and Polysorbate 80 based artificial tear intervention 2: Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear intervention 3: Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
Intervention descriptions: intervention 1: 1-2 drops in each eye, as needed, but at least twice daily intervention 2: 1-2 drops in each eye, as needed, but at least twice daily intervention 3: 1-2 drops in each eye, as needed, but at least twice daily

Protocol documents:
Clinical trial NCT01012219
Conditions: Primary Hypercholesterolemia Mixed Hyperlipidemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-11-01; Completion date: 2010-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a 3-period study. Periods 1 and 2 will evaluate the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 will be open-label and will evaluate single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.

Detailed description:

Arms: arm 1: In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). arm 2: In Periods 1 and 2 each participant will receive one of the following treatments in a randomized crossover fashion: Treatment A (aspirin 81 mg, clopidogrel 75 mg and laropiprant 40 mg once daily for 7 days) or Treatment B (aspirin 81 mg, clopidogrel 75 mg and placebo to laropiprant 40 mg once daily for 7 days). arm 3: None
Interventions: intervention 1: niacin (+) laropiprant intervention 2: Comparator: aspirin intervention 3: Comparator: clopidogrel intervention 4: Comparator: laropiprant intervention 5: Comparator: placebo
Intervention descriptions: intervention 1: open-label, single dose Tredaptive (1000mg ER niacin/ 20mg laropiprant) 2 oral tablets intervention 2: 81 mg oral tablet once daily for 7 days intervention 3: 75 mg oral tablet once daily for 7 days intervention 4: 40 mg oral tablet once daily for 7 days intervention 5: placebo oral tablet once daily for 7 days

Protocol documents:
Clinical trial NCT01016834
Conditions: Migraine
Keywords: migraine treatment satisfaction
Sponsor: Zogenix, Inc.
Start date: 2009-11-01; Completion date: 2010-04-01
Enrollment: 246 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel DosePro to treat their moderate to severe migraines.

Detailed description:
Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a 60 day period and complete migraine diaries and questionnaires.

Arms: arm 1: Single arm study (Sumavel DosePro)
Interventions: intervention 1: Sumavel DosePro intervention 2: Sumatriptan
Intervention descriptions: intervention 1: Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration intervention 2: subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period

Protocol documents:
Clinical trial NCT01016977
Conditions: Acne Vulgaris
Sponsor: Stiefel, a GSK Company
Start date: 2009-10-01; Completion date: 2010-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel / 0.1% Tazorac Cream and Acanya Gel / 0.1% Tazorac Cream for the treatment of facial acne vulgaris.

Detailed description:
This is a single-blind (investigator-blinded), randomized, parallel group, single center study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately 40 male and female subjects will be enrolled (20 per study group).

Subjects will participate in the study for 12 weeks; visits will be scheduled at baseline and at weeks 1, 2, 4, 8, and 12 (total of 6 visits). Eligible subjects will be randomized at baseline to 1 of the 2 study groups in a 1:1 ratio (Duac Gel/Tazorac Cream to Acanya Gel/Tazorac Cream). Subjects will apply either Duac Gel or Acanya Gel to the face each morning and apply Tazorac Cream to the face each evening.

Tolerability will be evaluated through subject assessments of burning/stinging, itching, and oiliness and through investigator assessments of peeling, erythema, and dryness. In addition, subjects will evaluate their overall skin comfort and record the usage of moisturizer and sunscreen, if needed. Efficacy will be assessed through lesion counts (total, inflammatory and noninflammatory) and ISGA. Safety will be assessed by evaluating adverse events (AEs), concomitant medication use, and withdrawals from the study.

This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation. Subjects (and parents or legal guardians) and study-center staff will be instructed not to reveal study product allocation to the investigator.

Arms: arm 1: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene arm 2: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Interventions: intervention 1: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene intervention 2: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene
Intervention descriptions: intervention 1: Clindamycin 1%/Benzoyl Peroxide 5% and 0.1% tazarotene intervention 2: clindamycin phosphate 1.2%/benzoyl peroxide 2.5% and 0.1% tazarotene

Protocol documents:
Clinical trial NCT01020799
Conditions: Major Depressive Disorder
Keywords: Depression
Sponsor: AstraZeneca
Start date: 2009-11-01; Completion date: 2010-04-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.

Detailed description:

Arms: arm 1: The AZD7268 15 mg BID arm consisted of 3 AZD7268 5 mg capsules dosed orally in the morning and evening. In addition, 2 placebo tablets to match encapsulated escitalopram tablets were dosed orally in the morning only. arm 2: The placebo arm consisted of 3 placebo capsules to match AZD7268 capsules dosed orally in the morning and evening. In addition, 2 placebos to match encapsulated escitalopram tablets were dosed orally in the morning only. arm 3: The escitalopram 20 mg QD arm consisted of 3 placebo to match AZD7268 capsules dosed orally in the morning and evening. In addition, during Week 1, one encapsulated 10-mg escitalopram tablet and 1 placebo to match encapsulated escitalopram tablet were dosed orally in the morning only. During Weeks 2 through 4, two encapsulated 10-mg escitalopram tablets were dosed orally in the morning only.
Interventions: intervention 1: AZD7268 intervention 2: Escitalopram intervention 3: Placebo capsules intervention 4: Placebo tablets
Intervention descriptions: intervention 1: 15 mg, oral, twice daily (BID) intervention 2: 20 mg, oral, once daily (QD) intervention 3: Placebo capsules to match AZD7268 intervention 4: Placebo tablets to match encapsulated escitalopram

Protocol documents:
Clinical trial NCT01055769
Conditions: Healthy Volunteers
Keywords: Bio-equivalence Linezolid OS Linezolid tablet
Sponsor: Pfizer
Start date: 2010-03-01; Completion date: 2010-04-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.

Detailed description:
To support Linezolid NDA in China.

Arms: arm 1: Subjects will accept Linezolid OS 600 MG first, after 4 days wash-out, then will accept Linezolid tablet 600 MG. arm 2: Subjects will accept Linezolid tablet 600 MG first, after 4 days wash-out, then will accept Linezolid OS 600 MG.
Interventions: intervention 1: Linezolid intervention 2: Linezolid
Intervention descriptions: intervention 1: 1. Linezolid OS 600 MG
2. Linezolid Tablet 600 MG intervention 2: 1. Linezolid Tablet 600 MG
2. Linezolid OS 600 MG

Protocol documents: