ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00703885
Conditions: Anxiety Disorders
Keywords: functional magnetic resonance imaging fMRI alprazolam anxiety disorders
Sponsor: University of California, San Diego
Start date: 2008-01-01; Completion date: 2008-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function.

Detailed description:
Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a different medication, alprazolam. An eventual aim of this study, in combination with future studies, is to evaluate the utility of fMRI as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

Arms: arm 1: 0.25 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan.

One-time, single dose.

Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. arm 2: 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan

One-time, single dose.

Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. arm 3: Inactive ingredient in liquid matching appearance and volume of the two active alprazolam dose comparators.

Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
Interventions: intervention 1: 0.25 mg alprazolam intervention 2: 1.0 mg alprazolam intervention 3: placebo
Intervention descriptions: intervention 1: 0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan

Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. intervention 2: 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan

Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. intervention 3: Placebo (liquid) to be administered 1 hour prior to fMRI scan

Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.

Protocol documents:
Clinical trial NCT00708110
Conditions: Infection, Human Immunodeficiency Virus
Keywords: dose-ranging study phase IIa integrase inhibitor HIV-1 infection
Sponsor: ViiV Healthcare
Start date: 2008-06-01; Completion date: 2008-08-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect, safety, tolerability, and pharmacokinetics of GSK1349572 monotherapy versus placebo over 10 days in ART-naïve and experienced, but integrase inhibitor naïve (meaning never having had an integrase inhibitor) HIV-1 infected adults who are not currently receiving antiretroviral therapy. This study consists of a screening visit, a treatment period and a follow-up evaluation. Thirty subjects will be randomized to receive one of three doses of GSK1349572 or placebo q24h over 10 days. Antiviral effect measures include viral load and CD4 cell count.

Detailed description:

Arms: arm 1: GSK1349572 2 mg or placebo every 24 hours for 10 days. Screening visit up to 30 days prior to first dose and follow-up for 11 days after last dose. arm 2: GSK1349572 10 mg or placebo every 24 hours for 10 days. Screening visit up to 30 days prior to first dose and follow-up for 11 days after last dose. arm 3: GSK1349572 50 mg or placebo every 24 hours for 10 days. Screening visit up to 30 days prior to first dose and follow-up for 11 days after last dose.
Interventions: intervention 1: GSK1349572 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK1349572 is an experimental drug being developed for the treatment of HIV. It is in the class of integrase inhibitors. intervention 2: Placebo is a tablet with no drug in it.

Protocol documents:
Clinical trial NCT00720057
Conditions: Toothache
Keywords: Dental Pain Analgesia
Sponsor: Bayer
Start date: 2008-06-01; Completion date: 2008-08-01
Enrollment: 312 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

Detailed description:

Arms: arm 1: single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. arm 2: Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.
Interventions: intervention 1: Naproxen Sodium ER (BAYH6689) intervention 2: Placebo
Intervention descriptions: intervention 1: Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery intervention 2: Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery

Protocol documents:
Clinical trial NCT00727857
Conditions: Diabetes Mellitus
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Drug Therapy
Sponsor: Takeda
Start date: 2007-06-01; Completion date: 2008-08-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus.

Detailed description:
Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 diabetes. Pioglitazone binds to peroxisome proliferator-activated receptors, an effect that is associated with altered transcription of genes capable of influencing carbohydrate and lipid metabolism.

Metformin hydrochloride is an oral antihyperglycemic drug not chemically or pharmacologically related to thiazolidinediones. Metformin is a biguanide, which has been shown to be effective in improving glycemic control in diabetic patients. Metformin inhibits hepatic glucose production, most likely through an inhibition of gluconeogenesis, and its use is associated with an improvement in tissue sensitivity to insulin. In accordance with published algorithms for the use of combination therapy for the treatment of type 2 diabetes, physicians have traditionally combined metformin with other antidiabetic agents.

This study will determine the effect of a fixed-dose combination of metformin with pioglitazone, compared to metformin monotherapy and pioglitazone monotherapy.

Study participation is anticipated to be approximately 6.5 months.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Pioglitazone and metformin intervention 2: Pioglitazone intervention 3: Metformin
Intervention descriptions: intervention 1: Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks. intervention 2: Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks. intervention 3: Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.

Protocol documents:
Clinical trial NCT00754442
Conditions: Secondary Hyperparathyroidism
Keywords: hyperparathyroidism parathyroid vitamin D vitamin D deficiency
Sponsor: University of Maryland, Baltimore
Start date: 2007-02-01; Completion date: 2008-08-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney function.

Detailed description:
Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it. Vitamin D must then be activated by both the liver and the kidneys to perform its function of maintaining strong bones and helping to prevent heart disease, infection, diabetes and cancer. Reduced kidney activation of Vitamin D occurs with advanced age and with all kidney diseases. We have identified a small group of patients who appear to have reduced ability of the kidneys to activate vitamin D, even though they are young and do not have chronic kidney disease. In these patients, we are comparing the ability of their kidneys to activate Vitamin D to that of healthy controls. To stimulate the kidneys to activate Vitamin D, we are giving parathyroid hormone intravenously over 8 hours and collecting blood and urine at baseline, 4 and 8 hours. This type of parathyroid infusion does not cause side effects. The gene that controls this activation is also being studied (by a simple blood test) to look for abnormalities. We are now actively recruiting healthy controls for this study.

Arms: arm 1: control subject arm 2: Patient with secondary hyperparathyroidism
Interventions: intervention 1: Teriparatide
Intervention descriptions: intervention 1: Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls"

Protocol documents:
Clinical trial NCT00761514
Conditions: Rheumatoid Arthritis
Sponsor: Abbott
Start date: 2006-11-01; Completion date: 2008-08-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate quality of life changes in Puerto Rican subjects with Rheumatoid Arthritis treated with Humira (adalimumab) as their first Anti-TNF Monoclonal Antibody.

Detailed description:

Arms: arm 1: All subjects will receive Adalimumab
Interventions: intervention 1: Humira (adalimumab)
Intervention descriptions: intervention 1: 40 mg eow

Protocol documents:
Clinical trial NCT00762372
Conditions: Anesthesia
Keywords: anesthesia desflurane
Sponsor: Baxter Healthcare Corporation
Start date: 2008-02-01; Completion date: 2008-08-01
Enrollment: 216 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.

Detailed description:
The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and muscle relaxants are concomitantly used. The study is also intended to demonstrate the non-inferiority of desflurane with nitrous oxide to sevoflurane with nitrous oxide in time to awakening/recovery.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: desflurane intervention 2: desflurane/nitrous oxide intervention 3: sevoflurane/nitrous oxide
Intervention descriptions: intervention 1: volatile liquid for inhalation intervention 2: volatile liquid for inhalation with gas for inhalation intervention 3: volatile liquid for inhalation and gas for inhalation

Protocol documents:
Clinical trial NCT00762450
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Start date: 2008-04-01; Completion date: 2008-08-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.

Detailed description:

Arms: arm 1: fluoride/triclosan/copolymer toothpaste arm 2: fluoride only toothpaste arm 3: fluoride/triclosan/amino acid toothpaste
Interventions: intervention 1: Triclosan, Fluoride intervention 2: fluoride intervention 3: Fluoride, triclosan, amino acid
Intervention descriptions: intervention 1: Rinse 3 times daily with assigned toothpaste slurry intervention 2: Rinse 3 times daily with assigned toothpaste slurry intervention 3: Rinse 3 times daily with assigned toothpaste slurry

Protocol documents:
Clinical trial NCT00762515
Conditions: Dental Plaque
Sponsor: Colgate Palmolive
Start date: 2008-02-01; Completion date: 2008-08-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to compare two commerical oral products for the treatment of gingivitis.

Detailed description:

Arms: arm 1: commercially available Fluoride only toothpaste arm 2: Commercially available triclosan/copolymer/fluoride toothpaste
Interventions: intervention 1: Fluoride intervention 2: Triclosan intervention 3: Fluoride
Intervention descriptions: intervention 1: Brush teeth two times daily for 6 weeks intervention 2: Brush two times daily for 6 weeks intervention 3: Brush two times daily for 6 weeks

Protocol documents:
Clinical trial NCT00762619
Conditions: Gingival Diseases
Sponsor: Colgate Palmolive
Start date: 2007-04-01; Completion date: 2008-08-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants

Detailed description:

Arms: arm 1: fluoride toothpaste (Ultrabrite) arm 2: fluoride/triclosan/copolymer toothpaste
Interventions: intervention 1: Fluoride intervention 2: Triclosan, fluoride
Intervention descriptions: intervention 1: Brush twice daily intervention 2: Brush twice daily

Protocol documents:
Clinical trial NCT00765206
Conditions: Gastric Acid Human Experimentation
Sponsor: Bayer
Start date: 2008-05-01; Completion date: 2008-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.

Detailed description:
Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs.

In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.

Arms: arm 1: Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule arm 2: Omeprazole magnesium 20 mg OTC tablet
Interventions: intervention 1: Omeprazole/sodium bicarbonate intervention 2: omeprazole magnesium (20 mg equivalent)
Intervention descriptions: intervention 1: Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days. intervention 2: Single dose of omeprazole magnesium per day for either 1 or 7 days.

Protocol documents:
Clinical trial NCT00790985
Conditions: Osteoarthritis of Knee
Sponsor: Primus Pharmaceuticals
Start date: 2008-01-01; Completion date: 2008-08-01
Enrollment: 223 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee.

Detailed description:
Efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee.

Arms: arm 1: flavonoid mixture arm 2: nonsteroidal anti-inflammatory drug
Interventions: intervention 1: flavocoxid intervention 2: Naproxen
Intervention descriptions: intervention 1: medical food intervention 2: antiinflammatory drug

Protocol documents:
Clinical trial NCT00807014
Conditions: Acne Vulgaris
Keywords: Differin quality of life Acne Duac Acne Vulgaris
Sponsor: Stiefel, a GSK Company
Start date: 2006-11-01; Completion date: 2008-08-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.

Detailed description:
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on the face, chest and back. Acne pathogenesis is recognized as multifactorial.

Acne vulgaris is the most common dermatological disorder. It affects approximately 85% individuals at some point in their lives, generally between 12 and 24 years of age. Although acne is prevalent within this age range, it can persist for many years and its long-term physical and psychological implications can be significant.

There are several medicinal products used to treat acne. However, the therapeutic challenge remains, therefore it is essential to continue investigating effective strategies for the treatment of this disease.

Arms: arm 1: Duac Gel arm 2: Differin gel
Interventions: intervention 1: Duac Gel intervention 2: Differin gel
Intervention descriptions: intervention 1: Duac® Gel will be applied to the face once daily at night, for 12 weeks. intervention 2: Differin Gel will be applied to the face once daily at night, for 12 weeks.

Protocol documents:
Clinical trial NCT00823199
Conditions: Schizophrenia
Sponsor: Bronx Psychiatric Center
Start date: 2005-11-01; Completion date: 2008-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10) poorly responsive patients with schizophrenia, monitoring their response and side-effects. No change in medication is required.

Detailed description:

Arms: arm 1: Allopurinal 300mg once daily by mouth for four weeks
Interventions: intervention 1: Allopurinal
Intervention descriptions: intervention 1: 300mg once daily by mouth for four weeks

Protocol documents:
Clinical trial NCT00837213
Conditions: Acne
Keywords: Acne
Sponsor: Stiefel, a GSK Company
Start date: 2007-08-01; Completion date: 2008-08-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne

Detailed description:
To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne

Arms: arm 1: Benzoyl peroxide (BPO) wash with clindamycin foam arm 2: Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules
Interventions: intervention 1: Benzoyl peroxide with clindamycin intervention 2: Benzoyl peroxide with clindamycin and doxycycline
Intervention descriptions: intervention 1: Benzoyl peroxide wash - Clindamycin foam intervention 2: Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules

Protocol documents:
Clinical trial NCT00848744
Conditions: Acne Vulgaris
Keywords: Acne
Sponsor: Northwestern University
Start date: 2008-02-01; Completion date: 2008-08-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is a split face, paired-comparison, pilot study of at least 10 subjects to complete. Participants in this study will be patients seen at Children's Memorial Hospital, who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be recruited from one of the clinics, as well as from previous Institutional Review Board (IRB) approved acne studies housed in the Department of Dermatology. All subjects accrued from previous studies have agreed to be contacted for further investigations. Subjects 13 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face, and meeting inclusion criteria will be eligible to participate

Detailed description:
Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules)1.

The basic cause of acne remains unknown, but its manifestations are thought to be the product of four pathogenic events: 1) increased sebum production fueled by androgenic stimulation in the pubertal period; 2) obstruction of the pilosebaceous unit due to an abnormal keratinization process; 3) proliferation of Propionibacterium acnes, an anaerobic diphtheroid normally residing in pilosebaceous follicles; and 4) inflammation that is mediated both by the action of chemotactic factors and various enzymes, and initiated in part by the interaction of P. acnes with toll-like receptors. Impaction of the pilosebaceous follicle gives rise to the microcomedo that is thought to be the precursor lesion of acne1.

Topical salicylic acid is a common and well-established agent with known keratolytic properties used in the treatment of acne vulgaris. The safety profile for topical salicylic acid has been well delineated. The most common side effects attributed to salicylic acid products include irritation, dryness, scaling, burning and stinging.

Salicylic acid 1.0% creams (Formulation A and Formulation B) will be evaluated to detect any differences in their response for safety and efficacy.

Arms: arm 1: None
Interventions: intervention 1: Formulation A intervention 2: Formulation B
Intervention descriptions: intervention 1: Formulation A will be applied to the randomly-assigned single (left or right) side of the face twice daily. intervention 2: Formulation B will be applied to the randomly-assigned single (left or right) side of the face twice daily.

Protocol documents: