ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01202955
Conditions: Nicotine Dependence
Keywords: Smoking, Abstinence
Sponsor: University of Pennsylvania
Start date: 2008-07-01; Completion date: 2009-06-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The goals of this within-subject pilot study are: (1) assess the feasibility and safety of administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms that promote relapse. A secondary exploratory goal is to assess whether these effects may be more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT val/val.

Detailed description:
Despite decades of research to develop pharmacotherapies for nicotine dependence (ND), with current FDA approved medications (bupropion, varenicline and NRTs) the majority (\>60%) of smokers relapse in the first year following treatment (Lerman, Patterson et al. 2005; Tonstad, Tonnesen et al. 2006). Testing novel medications that may reduce abstinence symptoms that prompt smoking relapse is a plausible route to identifying new treatments for nicotine dependence. The goals of this within-subject pilot study are: (1) assess the feasibility and safety of administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms that promote relapse. A secondary exploratory goal is to assess whether these effects may be more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT val/val. Sixteen smokers (8 met/met genotype and 8 val/val genotype) who meet study eligibility criteria will complete two 10-day medication periods: one while taking tolcapone and one while taking placebo (order counterbalanced). The testing session will occur on day 7 of each medication phase and include three computerized tasks. Participants will be asked to refrain from smoking for at least 14 hours (overnight) prior to the testing day in each medication phase. There will be a 3-day medication taper on days 8-10 of each medication period, followed by a washout period of at least 7 days between medication periods. The main outcomes to be evaluated are participant enrollment and retention, side effects, and performance on computerized tasks. Positive results from this pilot study would provide a basis for a larger scale investigation to assess the efficacy of tolcapone as a medication that ameliorates abstinence induced neurocognitive symptoms in smokers.

Arms: arm 1: Tolcapone arm 2: Placebo
Interventions: intervention 1: Tolcapone intervention 2: Placebo
Intervention descriptions: intervention 1: Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day intervention 2: Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day

Protocol documents:
Clinical trial NCT01203098
Conditions: Venous Thromboembolism Thromboembolism Thrombosis Embolism and Thrombosis Deep Vein Thrombosis Arthroplasty, Replacement, Hip
Keywords: prevention venous thromboembolism edoxaban anticoagulants
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2008-07-01; Completion date: 2009-06-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

Detailed description:

Arms: arm 1: DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery arm 2: Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery arm 3: DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery
Interventions: intervention 1: DU-176b 15mg intervention 2: DU-176b 30mg intervention 3: Enoxaparin sodium 20 mg (=2000IU)
Intervention descriptions: intervention 1: DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery. intervention 2: DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery. intervention 3: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.

Protocol documents:
Clinical trial NCT01431508
Conditions: Hypertension
Keywords: Hypertension
Sponsor: Organon and Co
Start date: 2007-08-01; Completion date: 2009-06-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension.

Detailed description:

Arms: arm 1: Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
Interventions: intervention 1: Losartan 50 mg / HCTZ 12.5 mg
Intervention descriptions: intervention 1: Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks

Protocol documents:
Clinical trial NCT01563172
Conditions: Dental Caries
Sponsor: GlaxoSmithKline
Start date: 2009-01-01; Completion date: 2009-06-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).

Detailed description:

Arms: arm 1: Participants brush twice a daily for 45 seconds with experimental dentifrice. arm 2: Participants brush twice a daily for 45 seconds with experimental dentifrice. arm 3: Participants brush twice a daily for 2 minutes with experimental dentifrice. arm 4: Participants brush twice a daily for 2 minutes with experimental dentifrice. arm 5: Participants brush twice a daily for 2 minutes with controll dentifrice.
Interventions: intervention 1: Sodium fluoride / silica and carbopol, 0.5g intervention 2: Sodium fluoride / silica and carbopol, 1.5g intervention 3: Sodium fluoride / silica and carbopol, 1.5g intervention 4: Fluoride free dentifrice
Intervention descriptions: intervention 1: Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol intervention 2: Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol intervention 3: Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol intervention 4: A non fluoride dentifrice was given to participants of each arm at washout period

Protocol documents:
Clinical trial NCT01577186
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Extended Release
Sponsor: Johnson & Johnson Taiwan Ltd
Start date: 2008-07-01; Completion date: 2009-06-01
Enrollment: 480 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in participants treated with flexibly dosed paliperidone ER.

Detailed description:
This is an open label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) 12-week study. Participants can be either in- or outpatients. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 0, 4, 8, and 12 (end of treatment or early withdrawal). Throughout the study, participants will receive paliperidone ER in a flexible dosing range of 3 to 12 milligram per day (mg/day). Efficacy will primarily be evaluated by PANSS and PSP scale. Participants' safety will also be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone ER
Intervention descriptions: intervention 1: Participants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion.

Protocol documents:
Clinical trial NCT01769339
Conditions: Vulva; Candidiasis
Keywords: Vulvar Candidiasis Miconazole Hydrocortisone Daktacort Feminine Care Cream
Sponsor: Janssen Pharmaceutica
Start date: 2009-01-01; Completion date: 2009-06-01
Enrollment: 115 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast infection of the vulva).

Detailed description:
This is an open label (all people know the identity of the intervention), single-arm, prospective (study following participants forward in time) study to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in participants with vulvar candidiasis. Participants will be evaluated and assessed on the degree of pruritus (itchiness) and screened for candidiasis on the baseline. Participants will apply the cream once enrolled and will be assessed for 1-hour to get the time to relief. Each participant will apply the study medication topically (applied to skin) to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the vulvar area affected and the treatment should be continued without interruption. Participants will be followed-up after 14 days and will be assessed clinically for signs and symptoms of vulvar candidiasis; if not cured, participants will continue the medication up to Day 28. Primary efficacy endpoint will be the time needed to achieve pruritus relief. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Miconazole plus Hydrocortisone
Intervention descriptions: intervention 1: Participants will apply miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the affected vulvar (the tissues around the opening to the vagina) area and the treatment should be continued without interruption. Participants will be assessed for signs and symptoms of vulvar candidiasis at Day 14. Medication will be continued till Day 28, if signs and symptoms of vulvar candidiasis are not cured clinically on Day 14.

Protocol documents:
Clinical trial NCT01774903
Conditions: Low Back Pain
Keywords: Low Back Pain TTS-fentanyl Durogesic
Sponsor: Janssen-Cilag Ltd.,Thailand
Start date: 2008-08-01; Completion date: 2009-06-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in severe (very serious, life threatening) chronic (lasting a long time) low back pain in Thai participants.

Detailed description:
This is an open label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic low back pain. All participants start treatment with 12.5 micrograms (µg) per hour patch. The patches will be replaced every 3 days. On Day 3, and every 3 days thereafter, the TTS-fentanyl dose increases will be considered based on rescue medication consumption and pain assessment. No increase in TTS-fentanyl dose will be performed within the 72-hour dosing interval. The duration of the treatment will be 30 days. Primary efficacy assessment will be pain control rated by participants. Assessment time points will be at Day 0 (baseline), on Day 15 and Day 30 (trial end). At the end of study, global preference on efficacy, side effects and overall satisfaction will also be rated by investigator and participants. Participants' safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: TTS-fentanyl
Intervention descriptions: intervention 1: TTS-fentanyl patches releasing drug at the rate of 12.5 microgram (µg) per hour for 3 days. The patches will be replaced every 3 days until 30 days.

Protocol documents:
Clinical trial NCT02563834
Conditions: Type 2 Diabetes Mellitus
Sponsor: Indiana University
Start date: 2007-01-01; Completion date: 2009-06-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Studies of myocardial fuel selection using a novel palmitate-based PET probe

Detailed description:
A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions.

Arms: arm 1: Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). arm 2: Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).
Interventions: intervention 1: thiapalmitate tracer intervention 2: Saline intervention 3: Insulin
Intervention descriptions: intervention 1: Radiolabeled tracer infusion; occurs in all treatment arms intervention 2: Saline infusion for control intervention 3: Insulin infusion for insulin/glucose clamp procedure

Protocol documents:
Clinical trial NCT02774278
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-07-01; Completion date: 2009-06-01
Enrollment: 264 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.

Detailed description:

Arms: arm 1: Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.

Protocol documents:
Clinical trial NCT00411684
Conditions: Emergency Contraception
Sponsor: HRA Pharma
Start date: 2006-11-01; Completion date: 2009-06-05
Enrollment: 1623 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.

Detailed description:

Arms: arm 1: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
Interventions: intervention 1: CDB-2914
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00891982
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Sponsor: Stiefel, a GSK Company
Start date: 2009-04-01; Completion date: 2009-06-05
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.

Detailed description:

Arms: arm 1: Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening arm 2: Soap Free Cleanser in the morning and CTGel in the evening
Interventions: intervention 1: CTGel/ BPO Wash intervention 2: Soap Free Cleanser and CTGel
Intervention descriptions: intervention 1: Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days

Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days. intervention 2: Soap Free Cleanser will be used once daily in the morning for 28 days

Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.

Protocol documents:
Clinical trial NCT00484718
Conditions: Osteoarthritis
Sponsor: Pfizer
Start date: 2008-01-17; Completion date: 2009-06-10
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The Purpose of this trial is to evaluate the use of a cross-over trial design in an osteoarthritis population. We will determine the inter- and intra-subject variability in osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA endpoints following treatment with 2 different types of analgesics in a crossover study of this design.

Detailed description:
Methodology study to evaluate the use of a cross over design and gait analysis. The study was terminated by mutual consent with the study site at a meeting on the 1 April 2009, because of slow recruitment due to a high screen fail rate. The study was not stopped for safety reasons.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: celecoxib intervention 2: Oxycodone intervention 3: placebo
Intervention descriptions: intervention 1: oral, 100 mg bid intervention 2: oral, 20 mg bid intervention 3: oral bid

Protocol documents:
Clinical trial NCT00423150
Conditions: Colorectal Neoplasm Head and Neck Neoplasm Carcinoma, Non-Small-Cell Lung Esophageal Neoplasm
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-01-26; Completion date: 2009-06-11
Enrollment: 86 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Temozolomide
Intervention descriptions: intervention 1: Temozolomide capsules 150 mg/m\^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.

Protocol documents:
Clinical trial NCT03644108
Conditions: Healthy Subjects
Sponsor: Reckitt Benckiser Inc.
Start date: 2009-06-04; Completion date: 2009-06-15
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects

Detailed description:

Arms: arm 1: Single dose of Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet taken with 240 mL of water after an overnight fast
Interventions: intervention 1: Mucinex® ER 600 mg
Intervention descriptions: intervention 1: Single dose of Mucinex® 600 mg ER Bi-Layer tablet

Protocol documents:
Clinical trial NCT00875017
Conditions: Kidney Failure, Chronic
Sponsor: Shire
Start date: 2009-04-20; Completion date: 2009-06-16
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the absorption of dietary phosphorus following a single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate (2400mg).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Lanthanum Carbonate intervention 2: Sevelamer
Intervention descriptions: intervention 1: 1 x 1000mg tablet intervention 2: 3 x 800mg tablets

Protocol documents:
Clinical trial NCT00612456
Conditions: Macular Degeneration
Keywords: angiogenesis pazopanib, age-related macular degeneration (AMD), vascular endothelial growth factor (VEGF), choroidal neovascularization (CNV),
Sponsor: GlaxoSmithKline
Start date: 2008-03-05; Completion date: 2009-06-17
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 28 day study to evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients

Detailed description:
Pazopanib has been formulated as an eye drop for the topical treatment of age-related macular degeneration (AMD). Safety, tolerability and pharmacokinetics have been evaluated in a first study conducted in healthy volunteers (MD7108238). In the present study, three dosing regimens of pazopanib eye drops, administered for 28 days, will be evaluated in subjects with occult or minimally classic subtypes of choroidal neovascularization due to AMD. This study is designed to measure pharmacological activity of topically administered pazopanib in target tissues (choroid and retina) of patients with AMD by weekly evaluation of central retinal thickness as measured by optical coherence tomography (OCT). Evaluation of efficacy will be performed on an exploratory basis by weekly measurement of visual acuity. The ocular and systemic safety and systemic pharmacokinetics of pazopanib treatment for 28 days will also be evaluated.

Arms: arm 1: Pazopanib eye drops formulation 5 mg/mL daily for 28 days arm 2: Pazopanib eye drop formulation 5mg/mL TID for 28 days arm 3: Pazopanib eye drop formulation 2mg/mL TID for 28 days
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: Pazopanib eye drops formulation

Protocol documents:
Clinical trial NCT00880750
Conditions: End Stage Renal Disease
Keywords: End stage Renal disease
Sponsor: Shire
Start date: 2009-01-28; Completion date: 2009-06-22
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.

Detailed description:

Arms: arm 1: Lanthanum carbonate granulated formulation crossover to chewable tablet formulation arm 2: Lanthanum carbonate chewable table formulation crossover to granulated formulation
Interventions: intervention 1: Lanthanum carbonate Granule Formulation intervention 2: Lanthanum carbonate Chewable Tablets (Fosrenol)
Intervention descriptions: intervention 1: 3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.) intervention 2: 3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.)

Protocol documents: