ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00944554
Conditions: Recurrence Smoking Cessation Substance-Related Disorders
Keywords: Relapse Smoking Cessation Substance Abuse
Sponsor: Johns Hopkins University
Start date: 2008-10-01; Completion date: 2011-05-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

Detailed description:
In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.

Arms: arm 1: Group given placebo. arm 2: Experimental group given varenicline dosing.
Interventions: intervention 1: Varenicline intervention 2: Placebo
Intervention descriptions: intervention 1: Varenicline given twice a day or five weeks. intervention 2: Placebo given twice a day or five weeks.

Protocol documents:
Clinical trial NCT00946478
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis elidel pimecrolimus CASM981 immunity cathelicidin antimicrobial peptide eczema
Sponsor: University of California, San Diego
Start date: 2009-10-01; Completion date: 2011-05-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of topical pimecrolimus on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with eczema. It is hypothesized that pimecrolimus applied topically will repair the body's immune system in patients with eczema by increasing antimicrobial peptides.

Detailed description:
Patients with atopic dermatitis (AD) have higher rates of skin infections from viruses and bacteria. They also have an impaired innate immune system. Antimicrobial peptides are a component of the innate immune system which are decreased in atopics. In vitro, pimecrolimus has demonstrated its ability to increase antimicrobial peptides. This study will examine the ability of pimecrolimus to increase antimicrobial peptides in vivo in AD patients. Thus, the study will yield a better understanding of the role of pimecrolimus in regulating the immune system in atopics.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pimecrolimus intervention 2: Vehicle cream
Intervention descriptions: intervention 1: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1.

Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit). intervention 2: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. Lesional target site and non-lesional site will be determined at Visit 1.

Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).

Protocol documents:
Clinical trial NCT00948389
Conditions: Glioblastoma
Sponsor: Bristol-Myers Squibb
Start date: 2009-10-01; Completion date: 2011-05-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dasatinib intervention 2: Lomustine
Intervention descriptions: intervention 1: Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity intervention 2: Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity

Protocol documents:
Clinical trial NCT00948506
Conditions: Prevention of Hair Growth
Sponsor: University of Pennsylvania
Start date: 2009-07-01; Completion date: 2011-05-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-arm, single center placebo-controlled double-blind proof of concept study which will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to placebo for the prevention of hair growth.

Detailed description:
This is a phase II randomized, placebo controlled double blind, dose-ranging clinical trial of topical cidofovir for the prevention of hair growth. This proof of concept study will evaluate 1% and 3% cidofovir in petrolatum topically applied once a day to the target treatment area on the hair bearing area of the face known as the beard area. This target area will be of a circular shape with a diameter of three centimeters along the jaw line of one side of the face.The first 14 enrolled subjects in the study will be randomized in a 1:1 fashion to receive either 1% topical cidofovir and placebo or 3% topical cidofovir and placebo. The last cohort of subjects to be enrolled in the study to achieve a total of 16 evaluable subjects will all receive the 3% formulation and placebo. Subjects will also be randomized as to which side of their face (left or right) will receive active drug versus placebo.

Subjects will be treated for up to eight weeks. Any subject who achieves 100% alopecia (which corresponds to a 0 on the PGA of Hair Density) in the treated area prior to eight weeks will be classified as a responder and will discontinue active treatment and begin the four week observation period. From the time of discontinuing treatment, subjects will be followed for four weeks during which time safety data will be collected.

Arms: arm 1: 1% topical cidofovir to one side of the face and placebo to the other side of the face arm 2: 3% topical cidofovir to one side of the face and placebo to the other side of the face
Interventions: intervention 1: 1% topical cidofovir intervention 2: 3% topical cidofovir intervention 3: Placebo
Intervention descriptions: intervention 1: 1% topical cidofovir intervention 2: 3% topical cidofovir intervention 3: topical placebo

Protocol documents:
Clinical trial NCT00954538
Conditions: Alzheimer's Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-08-01; Completion date: 2011-05-01
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will estimate the radiochemical and radiation safety and assess the efficacy of \[18F\]MK-3328, a novel positron emission tomography (PET) tracer. The study safety hypotheses will test whether \[18F\]MK-3328 is sufficiently safe and well-tolerated, based on an assessment of clinical and laboratory evaluations and adverse experiences in healthy participants, including healthy elderly (HE) participants, and Alzheimer's disease (AD) participants, to permit continued investigation. The study efficacy hypothesis will test whether \[18F\]MK-3328 can discriminate between AD participants and cognitively normal elderly control participants based on tracer volume of distribution, or one of its surrogates, in brain posterior cingulate gyrus.

Detailed description:

Arms: arm 1: Healthy participants will receive a single intravenous (IV) dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part I of the study arm 2: HE and AD participants will receive a single IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part II of the study arm 3: HE and AD participants will receive two separate IV doses of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part III of the study
Interventions: intervention 1: [18F]MK-3328
Intervention descriptions: intervention 1: IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328

Protocol documents:
Clinical trial NCT00961415
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-08-01; Completion date: 2011-05-01
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is \<500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: cisplatin intervention 3: pemetrexed
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 of each 3-week cycle intervention 2: 75mg/m2 iv on day 1 of each 3-week cycle intervention 3: 500mg/m2 iv on day 1 of each 3-week cycle

Protocol documents:
Clinical trial NCT00975143
Conditions: Severe Nodular Acne
Keywords: isotretinoin dermatology skin
Sponsor: Cipher Pharmaceuticals Inc.
Start date: 2009-09-01; Completion date: 2011-05-01
Enrollment: 925 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of CIP-Isotretinoin and a marketed (generic) formulation of isotretinoin when both are administered twice daily with meals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CIP-Isotretinoin intervention 2: Isotretinoin
Intervention descriptions: intervention 1: 0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily. intervention 2: 0.5 mg/kg/day for 4 weeks, and 1 mg/kg/day for 16 weeks, taken orally, twice daily.

Protocol documents:
Clinical trial NCT00977080
Conditions: Chronic Kidney Disease Secondary Hyperparathyroidism Hemodialysis
Keywords: Zemplar paricalcitol IMPACT SHPT Hemodialysis Chronic Kidney Disease Stage 5
Sponsor: Abbott
Start date: 2009-11-01; Completion date: 2011-05-01
Enrollment: 272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.

Detailed description:
During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet or paricalcitol. Participants who were assigned to receive paricalcitol were dosed according to the approved label in their respective geographic regions (i.e., IV at sites in the US and Russia and oral at sites in Europe). Supplemental cinacalcet was administered to participants in the paricalcitol arms who developed hypercalcemia (defined as \>= 10.5 mg/dL). The evaluation period was from Weeks 21 to 28.

Arms: arm 1: Participants in the IV stratum received intravenous (IV) paricalcitol and, if hypercalcemia (calcium \>= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at 0.07 mcg/kg with titration every 2 weeks. arm 2: Participants in the IV stratum received 30 mg of oral cinacalcet daily with a low-dose vitamin D receptor activator (VDRA) (doxercalciferol IV 1 mcg 3 times weekly (TIW) at sites in the US and alfacalcidol capsules 0.25 mcg daily at sites in Russia). arm 3: Participants in the oral stratum received oral paricalcitol and, if hypercalcemia (calcium \>= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at mcg = IPTH/60 3 times weekly (TIW) with titration every 2 weeks. arm 4: Participants in the oral stratum received 30 mg of oral cinacalcet daily with a low-dose vitamin D receptor activator (VDRA) (alfacalcidol capsules 0.25 mcg daily).
Interventions: intervention 1: Paricalcitol intervention 2: Cinacalcet
Intervention descriptions: intervention 1: Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia) intervention 2: On-label oral cinacalcet by region with low dose vitamin D receptor activator (VDRA) (either doxercalciferol at US sites or alfacalcidol at non-US sites)

Protocol documents:
Clinical trial NCT00995410
Conditions: Aspirin-Associated Gastric Ulcers
Keywords: Subjects Who are at Risk for Developing Aspirin-ASA Subject must have a pre-existing condition for which aspirin is already indicated Gastric Ulcers
Sponsor: POZEN
Start date: 2009-10-01; Completion date: 2011-05-01
Enrollment: 380 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study uses an open-label design and will be conducted in approximately 40 sites in the United States. Approximately 400 subjects will be enrolled in the study to ensure that approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects will have 12 months exposure to PA32540.

Detailed description:
PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers. This study is designed to provide long-term safety data for PA32540 in order to gain regulatory approval to make PA32540 available for clinical use in this subject population.

Arms: arm 1: 325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily
Interventions: intervention 1: PA32540
Intervention descriptions: intervention 1: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily

Protocol documents:
Clinical trial NCT01012414
Conditions: Coronary Artery Disease Chronic Kidney Disease Hypovitaminosis D Secondary Hyperparathyroidism
Keywords: Vitamin D Coronary Artery Disease (CAD) Chronic Kidney Disease (CKD)
Sponsor: Thomas Jefferson University
Start date: 2010-01-01; Completion date: 2011-05-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if vitamin D supplementation changes the results of certain tests associated with inflammation in the body using an oral, synthetic form of vitamin D called paricalcitol.

Detailed description:
Vitamin D deficiency is common and has been associated with an increased risk of heart disease. In patients with the combination of kidney disease and heart disease, inflammation is thought to contribute to a high rate of cardiac events. Less is known about the effects of vitamin D supplementation on certain tests associated with inflammation in the body.

Arms: arm 1: oral paricalcitol 2 mcg daily arm 2: one oral placebo drug daily
Interventions: intervention 1: paricalcitol intervention 2: placebo
Intervention descriptions: intervention 1: 2 mcg oral paricalcitol daily intervention 2: placebo

Protocol documents:
Clinical trial NCT01035346
Conditions: Infection
Keywords: Fever antipyretic uncomplicated acute viral infection uncomplicated acute bacterial infections
Sponsor: Pfizer
Start date: 2010-01-01; Completion date: 2011-05-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ibuprofen intervention 2: Placebo
Intervention descriptions: intervention 1: Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen) intervention 2: Single dose of a placebo

Protocol documents:
Clinical trial NCT01038128
Conditions: Bulimia Nervosa Body Dysmorphic Disorder
Keywords: Bulimia nervosa Bulimia Body dysmorphic disorder Eating disorders Body image Binge eating purging
Sponsor: Mclean Hospital
Start date: 2009-12-01; Completion date: 2011-05-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this 13-week clinical trial is to test the hypothesis that treatment with Memantine will significantly improve the symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.

Detailed description:
The primary objective of this clinical trial is to test the hypothesis that treatment with Memantine, an anti-glutamatergic drug, will significantly improve the core symptoms of those suffering from either bulimia nervosa, purging type or suffering from body dysmorphic disorder.

We will test this hypothesis by performing a 13-week open label study investigating the use of memantine, at a dose of 10-40mg daily, as a treatment for patients with either bulimia nervosa or body dysmorphic disorder. Improvement for patients with bulimia nervosa will be assessed using the Frequency of binge eating and vomiting as recorded in diary card, Eating Disorder Evaluation (EDE), and the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS). Improvement for patients with body dysmorphic disorder will be assessed using the the Yale-Brown-Cornell Eating Disorders Scale (YBC-EDS) and Brown Assessments of Beliefs Scale. In addition both groups will also receive the Clinical Global Impression (CGI) Severity and Improvement Scales (clinician rated), Patient Global Impression of Improvement (PGI-Improvement), Montgomery Asberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Barratt Impulsiveness Scale (BIS), Version 11, Sheehan Disability Scale (SDS), and Columbia Suicide Severity Rating Scale (C-SSRS).

Arms: arm 1: Memantine, 10-40 mg daily
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: Drug: Memantine, 10-40 mg daily

Protocol documents:
Clinical trial NCT01109173
Conditions: Cataract
Sponsor: Alcon Research
Start date: 2010-06-01; Completion date: 2011-05-01
Enrollment: 2120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.

Detailed description:

Arms: arm 1: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery. arm 2: Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. arm 3: Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery. arm 4: Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
Interventions: intervention 1: Nepafenac Ophthalmic Suspension, 0.3% intervention 2: Nepafenac Ophthalmic Suspension, 0.1% intervention 3: Nepafenac Ophthalmic Suspension 0.3% Vehicle intervention 4: NEVANAC Vehicle
Intervention descriptions: intervention 1: Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery. intervention 2: Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days intervention 3: Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery. intervention 4: Nepafenac vehicle, one drop in affected eye three times daily, for 16 days

Protocol documents:
Clinical trial NCT01122511
Conditions: Subfoveal Choroidal Neovascularization Age-Related Maculopathy
Sponsor: Allergan
Start date: 2010-08-01; Completion date: 2011-05-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration

Detailed description:

Arms: arm 1: Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye arm 2: Intravitreal injection of ranibizumab and Sham into study eye
Interventions: intervention 1: 700 ug dexamethasone intervention 2: ranibizumab intervention 3: sham
Intervention descriptions: intervention 1: Intravitreal injection of 700 ug dexamethasone into study eye intervention 2: Intravitreal injection of ranibizumab into study eye intervention 3: Sham needle-less injection administered in the study eye

Protocol documents: